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Acute Myeloid Leukemia


A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FLT3/ITD AML in First Complete Remission

The purpose of the study is to see if a medicine called gilteritinib (ASP2215) is both effective and safe as maintenance treatment (treatment you will receive to maintain the response achieved during the first course of your treatment) for AML patients who are in a first complete remission (no residual leukemia cells in your bone marrow), with mutations in the FLT3 gene compared to placebo given alone.

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Amyloidosis


AL Amyloidosis - Assessing Treatments for Patients with Relapsed or Refractory Systemic Light Chain AL Amyloidosis

This is a phase 3, randomized, controlled, open-label, multicenter study of the oral formulation of dexamethasone plus MLN9708 (investigational study drug) compared with treatment chosen by the investigator from a prespecified list of regimens available in clinical practice. Treatment options will include: dexamethasone alone, dexamethasone plus an alkylating agent (melphalan or cyclophosphamide), or dexamethasone plus an immunomodulatory drug ([IMiD], thalidomide or lenalidomide) in patients with relapsed or refractory AL amyloidosis. The sponsor is Millennium Pharmaceuticals Inc. For any questions, please call the number listed above. Participants may also view clinicaltrials.gov for any additional information.

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A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis

The purpose of this study is to evaluate whether NEOD001, the study drug, will improve survival in subjects with AL amyloidosis and/or increase the interval of time that they can go without requiring hospitalization for problems with their hearts.  This study will also evaluate whether NEOD001 improves the function of subjects’ organs that have been affected by amyloid deposits.

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Ankylosing Spondylitis


A Multicenter, Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study To Evaluate The Efficacy And Safety Of Bimekizumab In Subjects With Active Ankylosing Spondylitis

BE AGILE 1 is evaluating a new drug called bimekizumab for patients with Ankylosing spondylitis. Bimekizumab is investigational, which means it is still being tested and has not yet been approved for treatment by health authorities. Bimekizumab may help lower the level of activity of interleukin-17A (IL-A) and interleukin-17F (IL-17F); two proteins that are involved in an inflammatory response believed to cause the symptoms of anklysing spondylitis. The purpose of this study is to help us understand how safe and effective different doses of bimekizumab are in treating your condition. It will also help us understand how bimekizumab acts in your body, and how your body reacts to bimekizumab.

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Bone Marrow Transplant


A Single-arm, Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients who Have Failed to Respond to Steroid Treatment for Acute GVHD

The main purpose of the study is to find out about whether the study drug, Remestemcel-L, is safe in humans and an effective product in pediatric patients with acute Graft versus Host Disease (GVHD). GVHD may occur after a bone marrow or stem cell transplant in which someone receives bone marrow tissue or cells from a donor (called an allogeneic transplant). The new, transplanted cells attack the recipient's body (the host) because they regard it as foreign.

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Brain Tumors


A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1)

The main purposes of this study are to evaluate whether combining ABT-414 with usual RT and TMZ treatment controls GBM better than usual RT and TMZ without ABT-414, and whether ABT-414 makes patients live longer. This study will only include people whose tumors are tested and confirmed to have EGFR amplification.

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A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma

The purpose of this study is to:  1) see if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in subjects who have been diagnosed with cancer and are experiencing fatigue; and 2) see the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue. In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent).  Subjects will not take both. Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders.   However, it is not been studied in people with cancer related fatigue.

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Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Cancer

The purpose of this the study that you are now being asked to participate in is to determine how safe and effective the study drug, trastuzumab, is in patients with HER-2 positive cancer that has spread to the fluid around the brain and spinal cord.

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Phase II Trial Of SMO/AKT/NF2 Inhibitors In Progressive Meningiomas With SMO/AKT/ NF2 Mutations

The purpose of this study is to test good and bad effects of two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in meningioma patients. Researchers have looked at the DNA material (genes) that can be affected in meningioma and have found several genes that are altered, or mutated. These include the genes called SMO and NF2. When the SMO or NF2 genes are altered, it can cause a tumor to grow. There are drugs that target these 2 genes.

The study drug, vismodegib, blocks the SMO receptor. Vismodegib has already been FDA-approved to treat basal cell cancer, which is a type of skin cancer. Vismodegib could shrink cancer, but it could also cause side effects. The study drug, GSK2256098, blocks FAK, and seems to work better in tumors that have NF2-mutations. GSK2256098 has been tested in other cancers. Researchers hope to learn if either of the study drugs will shrink cancer.

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Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

The purpose of this study is to compare a different radiation schedule and higher radiation dose [higher dose group] to the standard dose of radiation [standard dose group]. Both groups will receive usual chemotherapy, temozolomide. The higher radiation dose could shrink brain cancer, but it could also cause side effects. This study will allow the researchers to know whether this higher dose is better, the same, or worse than the usual approach.

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Breast Cancer


A Phase 1, Open Label, Dose Escalation Study of MGA271 (Fcoptimized Humanized Anti-B7-H3 Monoclonal Antibody) in Patients with Refractory B7-H3-Expressing Neoplasms or Neoplasms Whose Vasculature Expresses B7-H3

The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it may have an effect on tumors.

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A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients with Triple Negative Breast Cancer

The purpose of this study is to test the theory that therapy designed for each individual’s tumor will improve outcomes over standard of care in a population that needs a better standard. Using tumor tissue samples from a prior surgery, treatment reccomendations will be made based on DNA sequencing of the tumor cells by a Cancer Genomics Tumor Board facilitated by the Hoosier Cancer Research Network. Subjects will be randomized to one of several treatment options based on their specific tumor genetic make-up, prior treatment history and tolerance, and medical history.

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Palbociclib Collaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer

The purpose of this study is to compare any good and bad effects of using 2 years of Palbociclib in combination with standard anti-hormone therapy to using standard anti-hormone therapy alone and to evaluate the likelihood that invasive breast cancer returns.

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Bronchopulmonary Dysplasia


Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome

The goal of this study is to assess the effectiveness of a new drug, rhCC10, on respiratory outcomes of premature infants with Respiratory Distress Syndrome.

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Cholesterol


Role of EPA and DHA in fish oil on inflammation and lipid metabolism

Inflammation plays an important role in several chronic diseases including cardiovascular disease, diabetes mellitus, and neurodegenerative disorders. Fish oil, containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), has been shown to reduce the risk or severity of these diseases. While it is generally assumed that EPA and DHA have similar effects, evidence is emerging of different modes of action of EPA and DHA. The objective of this study is to assess the differential and common effects of EPA and DHA on inflammation and lipid metabolism.

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Chronic Lymphocytic Leukemia


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

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Crohn's Disease


A Long-Term Non-Invasive Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Pediatric Patients with Moderately to Severly Active Crohn’s Disease

To find out more about children with Crohn’s Disease (CD) to help doctors improve the care of patients with this disease.

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A Multicenter, Prospective, Long-Term, Observational Registry of Pediatric Patients with Inflammatory Bowel Disease

A study designed to gain additional information on pediatric patients with Inflammatory Bowel Disease…Crohn’s Disease, Ulcerative Colitis, and Indeterminate Colitis

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Diabetes


Vitamin D and Type 2 Diabetes (D2d) Study

A clinical trial to test whether taking vitamin D daily lowers the risk of diabetes in people who are at high risk for diabetes (e.g. overweight, older than 40 years, family history of diabetes, or had diabetes during pregnancy). Participants will take 1 pill a day (vitamin D or placebo) for the duration of the 4 year study. Participants will visit the study site for up to 13 scheduled visits during their participation. All participants receive education on diabetes prevention and are monitored twice a year for diabetes.

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Diabetes Mellitus


Vitamin D and Type 2 Diabetes (D2d) Study

A clinical trial to test whether taking vitamin D daily lowers the risk of diabetes in people who are at high risk for diabetes (e.g. overweight, older than 40 years, family history of diabetes, or had diabetes during pregnancy). Participants will take 1 pill a day (vitamin D or placebo) for the duration of the 4 year study. Participants will visit the study site for up to 13 scheduled visits during their participation. All participants receive education on diabetes prevention and are monitored twice a year for diabetes.

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Ependymoma


ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years

This study is being done to evaluate what effects, if any, chemotherapy can have when added to the standard of care for this type of cancer. The current standard of care for this type of cancer is a surgery, to remove as much of the tumor as possible, followed by radiation. It will look at if chemotherapy, when added to the standard of care, affects the cancer from coming back.

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Glioblastoma


Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

The purpose of this study is to compare a different radiation schedule and higher radiation dose [higher dose group] to the standard dose of radiation [standard dose group]. Both groups will receive usual chemotherapy, temozolomide. The higher radiation dose could shrink brain cancer, but it could also cause side effects. This study will allow the researchers to know whether this higher dose is better, the same, or worse than the usual approach.

More

Glioma


A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma

The purpose of this study is to:  1) see if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in subjects who have been diagnosed with cancer and are experiencing fatigue; and 2) see the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue. In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent).  Subjects will not take both. Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders.   However, it is not been studied in people with cancer related fatigue.

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GVHD


A Single-arm, Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients who Have Failed to Respond to Steroid Treatment for Acute GVHD

The main purpose of the study is to find out about whether the study drug, Remestemcel-L, is safe in humans and an effective product in pediatric patients with acute Graft versus Host Disease (GVHD). GVHD may occur after a bone marrow or stem cell transplant in which someone receives bone marrow tissue or cells from a donor (called an allogeneic transplant). The new, transplanted cells attack the recipient's body (the host) because they regard it as foreign.

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Head and Neck Cancer


A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MEDI4736 in Combination With AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

This study is to evaluate the overall response rate of two experimental drugs, AZD9150 and AZD5069, both as single medicine treatments and in combination with another study drug,MEDI4736, in the second-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

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Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

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Hematologic Malignancies


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

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High Blood Pressure


Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension

The REDUCE HTN: REINFORCE study is testing a new procedure that could treat high blood pressure.  This procedure is called renal (kidney) denervation.  The study will be evaluating patients that have high blood pressure when they do not take medications. The study will compare the blood pressure of people who undergo the study procedure (renal denervation) with the blood pressure of those who undergo a sham procedure (a renal angiogram that will not include the renal denervation). The study’s purpose is to collect data about the safety and effectiveness of this renal denervation (disabling of kidney nerves) treatment for patients with uncontrolled hypertension.

The Vessix™ Renal Denervation System consists of a catheter (a thin tube) and a radio frequency (RF) generator (power generator).  The procedure involves the nerves that surround the blood vessel (artery) that supplies blood to the kidney (kidney artery). The generator sends energy through the kidney artery to disable the surrounding nerves. These nerves have a role in causing the kidneys to keep sodium (salt) in the body and in causing the amount of blood flowing into the filters in the kidney to be lower. These two things, among others, can then cause high blood pressure.  By disabling these nerves, the Vessix system aims to reduce the amount of salt kept in the body and therefore reduce blood pressure in the body.

Renal denervation is not a treatment currently used for high blood pressure management in the U.S.  The device is investigational in the United States. It is not approved by the U.S. FDA. The sponsor of this study is Boston Scientific Corporation.  

The study will include 100 subjects at up to 20 hospitals in the US (about 20 of these subjects will be enrolled at Tufts Medical Center). About 67 people of the 100 total will get the renal denervation procedure (study group) and about 33 people will get a “sham” procedure (control group). People will be randomly selected to one or the other group.  The doctor doing the procedure will know which group you are in when he is doing the procedure. Your Study Doctor will tell you whether you received the renal denervation procedure or the sham procedure at your 6 month follow-up visit. Until then, neither you nor your Study Doctor will know which procedure you received. The sham procedure is done to get data that is not influenced by knowing what procedure you received.

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Hodgkin Lymphoma


A Randomized Phase III Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents

This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma.

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Hypertension


Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension

The REDUCE HTN: REINFORCE study is testing a new procedure that could treat high blood pressure.  This procedure is called renal (kidney) denervation.  The study will be evaluating patients that have high blood pressure when they do not take medications. The study will compare the blood pressure of people who undergo the study procedure (renal denervation) with the blood pressure of those who undergo a sham procedure (a renal angiogram that will not include the renal denervation). The study’s purpose is to collect data about the safety and effectiveness of this renal denervation (disabling of kidney nerves) treatment for patients with uncontrolled hypertension.

The Vessix™ Renal Denervation System consists of a catheter (a thin tube) and a radio frequency (RF) generator (power generator).  The procedure involves the nerves that surround the blood vessel (artery) that supplies blood to the kidney (kidney artery). The generator sends energy through the kidney artery to disable the surrounding nerves. These nerves have a role in causing the kidneys to keep sodium (salt) in the body and in causing the amount of blood flowing into the filters in the kidney to be lower. These two things, among others, can then cause high blood pressure.  By disabling these nerves, the Vessix system aims to reduce the amount of salt kept in the body and therefore reduce blood pressure in the body.

Renal denervation is not a treatment currently used for high blood pressure management in the U.S.  The device is investigational in the United States. It is not approved by the U.S. FDA. The sponsor of this study is Boston Scientific Corporation.  

The study will include 100 subjects at up to 20 hospitals in the US (about 20 of these subjects will be enrolled at Tufts Medical Center). About 67 people of the 100 total will get the renal denervation procedure (study group) and about 33 people will get a “sham” procedure (control group). People will be randomly selected to one or the other group.  The doctor doing the procedure will know which group you are in when he is doing the procedure. Your Study Doctor will tell you whether you received the renal denervation procedure or the sham procedure at your 6 month follow-up visit. Until then, neither you nor your Study Doctor will know which procedure you received. The sham procedure is done to get data that is not influenced by knowing what procedure you received.

More

Inflammation


Role of EPA and DHA in fish oil on inflammation and lipid metabolism

Inflammation plays an important role in several chronic diseases including cardiovascular disease, diabetes mellitus, and neurodegenerative disorders. Fish oil, containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), has been shown to reduce the risk or severity of these diseases. While it is generally assumed that EPA and DHA have similar effects, evidence is emerging of different modes of action of EPA and DHA. The objective of this study is to assess the differential and common effects of EPA and DHA on inflammation and lipid metabolism.

More

Inflammatory Bowel Disease


A Multicenter, Prospective, Long-Term, Observational Registry of Pediatric Patients with Inflammatory Bowel Disease

A study designed to gain additional information on pediatric patients with Inflammatory Bowel Disease…Crohn’s Disease, Ulcerative Colitis, and Indeterminate Colitis

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Joint Disorders


A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-02 (Disodium Zoledronate Tetrahydrate) Administered Orally to Subjects with Knee Osteoarthritis Associated with Bone Marrow Lesions.

This is a phase 3 trial for the treatment of knee osteoarthritis associated with bone marrow lesions. The purpose of the study is to determine whether a study medication, AXS02 (disodium zoledronate tetrahydrate) can reduce bone marrow lesions, and therefore alleviate pain associated with osteoarthritis of the knee. AXS02 is an investigational drug and subjects are monitored to see if it causes any adverse event. Maximum participation is 21 weeks and may include up to 14 visits to Tufts Medical Center. A total of approximately 346 subjects are planned for enrollment. Subjects who are eligible for the study will receive AXS02 or placebo during visits 4-8 (1 tablet per week for 6 weeks). The following 6 visits consist of a number of tests and procedures to gather data.

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Leukemia


A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FLT3/ITD AML in First Complete Remission

The purpose of the study is to see if a medicine called gilteritinib (ASP2215) is both effective and safe as maintenance treatment (treatment you will receive to maintain the response achieved during the first course of your treatment) for AML patients who are in a first complete remission (no residual leukemia cells in your bone marrow), with mutations in the FLT3 gene compared to placebo given alone.

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AALL0932:  Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

This is a protocol for people with newly diagnosed Standard Risk Acute Lymphoblastic Leukemia. The study is broken up into parts. Each part of the study will be exploring different phases of chemotherapy such as Induction, Post-Induction, and Maintenance. In each phase of the study, researchers will be testing different experimental drug regimens versus standard treatments to see which one works better. Additionally, participants will be grouped based on their risk level and may receive different  chemotherapy regimens based on their risk.

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AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum

This study will look at how effective different combinations of chemotherapy are a preventing acute lymphoblastic leukemia from coming back.

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AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)

The aims of this study are to improve treatment for T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy). We want to see if adding bortezomib to the standard treatment reduces the chance that the cancer will come back.

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Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

  1. To find out if subjects with down syndrome and standard risk acute myeloid leukemia can be treated with less treatment and still have successful outcomes.
  2. To find out if subjects with down syndrome and high risk acute myeloid leukemia can be successfully treated with stronger chemotherapy.

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Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND#117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

This randomized phase III trial compares how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, can block cancer growth by finding cancer cells and helping to kill them or carrying cancer-killing substances to them. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

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Lung Cancer


An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations SOLAR Study

The purpose of the study is to collect information to determine if an investigational drug called ASP8273 is effective, safe and comparable to the treatments erlotinib or gefitinib that are already approved in the US, Europe and Asia, respectively, for patients with your type of NSCLC.

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Phase 2, Parallel-Arm Study of MGCD265 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Activating Genetic Alterations in Mesenchymal- Epithelial Transition Factor

The main purpose of this study is to test whether subjects with lung cancer, with specific changes in the tumor genes, benefit from getting study drug, MGCD265.  Other objectives of the study include assessing the side effects of MGCD265 in subjects, and how much and how quickly drug is absorbed and cleared from the blood stream.

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Lyme Disease


Xenodiagnosis After Antibiotic Treatment for Lyme Disease – Phase 2 study

Recent studies have shown that the causative agent of Lyme disease, the organism (Borrelia burgdorferi), may persist in animals after antibiotic treatment and can be detected by using the natural tick vector (Ixodes scapularis) to acquire the organism through feeding (xenodiagnosis). The aim of this study is to investigate the utility of xenodiagnosis for identifying persistence of infection with B. burgdorferi in treated human Lyme disease.

Our objectives include: (1) assessing the link between the detection of B. Burgdorferi by xenodiagnosis and the persistence of symptoms in patients diagnosed with Lyme disease, (2) comparing the rate of detection of B. burgdorferi by xenodiagnosis after therapy in participants with posttreatment Lyme disease symptoms, (3) identifying subject characteristics related to the likelihood of detecting B. burgdorferi by xenodiagnosis, and (4) continuing to evaluate the safety of xenodiagnosis in humans.

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Lymphomas


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

More

A Randomized Phase III Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents

This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma.

More

AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)

The aims of this study are to improve treatment for T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy). We want to see if adding bortezomib to the standard treatment reduces the chance that the cancer will come back.

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Mantle Cell Lymphoma


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

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Multiple Myeloma


A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

This study will assess whether taking ixazomib as maintenance therapy after standard treatments extends the period of time that a patient’s cancer stays inactive.

Maintenance therapy means that a drug is taken for a relatively long period (in this study, up to 24 months) to prolong the time that the myeloma remains under control after a prior therapy; in this study the prior therapy must not include autologous stem cell transplant.  It is not yet proven whether maintenance therapy given to people with multiple meyloma is better than waiting until the myeloma comes back to receive additional treatment.  The study will assess whether taking ixazomib immediately after responding to a prior therapy allows people with multiple myeloma to live longer by preventing or delaying the return of their disease.

This study is also being performed for these additional research purposes:

  • To evaluate the safety of ixazomib and to learn about the side effects associated with the use of this drug when it is used as a maintenance therapy.
  • To find out whether the presence of certain genes and proteins in the cancer cells of patients with multiple myeloma can predict whether ixazomib will work on cancers similar to yours.
  • To evaluate the health and overall well-being of patients while they are taking ixazomib.

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    Myelodysplastic Syndromes


    A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician’s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent

    The primary objective of this study is to compare the overall survival (OS) of patients receiving intravenous (IV) rigosertib to the OS of patients receiving the physician’s choice of treatment (PC) in a population of patients with myelodysplastic syndrome (MDS) after failure of treatment with a hypomethylating agent (HMA), azacitidine (AZA) or decitabine (DEC).

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    A Randomized Phase 2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Combination with Azacitidine Compared with Azacitidine Alone in Subjects with Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

    This is a Phase 2, open-label, 3-arm randomized, multicenter study designed to determine the safety, pharmacokinetics, and efficacy of venetoclax when administered with azacitidine, compared to azacitidine alone, in subjects with treatment-naïve higher-risk MDS.

    Approximately 90 subjects, from approximately 50 sites, will be enrolled with approximately 30 subjects to be randomized to each arm.

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    Neonatal Abstinence Syndrome


    Improving outcome in neonatal abstinence syndrome with included sub-study: Establishing Risk in Neonatal Abstinence Syndrome (NAS) Genomics Component

    The purpose of this research study is to find better ways to treat infants with Neonatal Abstinence Syndrome (NAS) and improve long-term outcome. The goal is to compare two common drugs and see which one works the best.

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    Neonatal Conditions


    Improving outcome in neonatal abstinence syndrome with included sub-study: Establishing Risk in Neonatal Abstinence Syndrome (NAS) Genomics Component

    The purpose of this research study is to find better ways to treat infants with Neonatal Abstinence Syndrome (NAS) and improve long-term outcome. The goal is to compare two common drugs and see which one works the best.

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    Neuroblastoma


    ANBL1232: Utilizing Response and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma: A Groupwide Historically Controlled Phase III Study

    In this study we are using new biologic features, in addition to the standard risk factors, to help decide which subjects need treatment and what the best treatment is. People with non-high-risk NBL generally respond well to treatment and the majority of patients can be treated successfully with standard therapy. But standard therapy can include risks from surgery and/or side effects from chemotherapy.Based on the evaluation of non-high-risk NBL patients treated in the past, we think that we can change the amount of therapy for subjects and still treat the cancer successfully. Small studies have shown that some subjects can be watched without having surgery or getting chemotherapy and still have an excellent outcome. By not having surgery or lowering the amount of chemotherapy we hope to prevent complications and harmful side effects. For other subjects we think a change in therapy will treat the cancer more successfully.

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    NMTT: Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

    The purpose of this research study is to evaluate an investigational drug (DFMO) for Neuroblastoma that is in remission. Remission means that there are no current signs of active cancer. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the ability of this study drug to keep neuroblastoma in remission and will also look at the safety and tolerability of DFMO.

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    Non Small Cell Lung Cancer


    An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations SOLAR Study

    The purpose of the study is to collect information to determine if an investigational drug called ASP8273 is effective, safe and comparable to the treatments erlotinib or gefitinib that are already approved in the US, Europe and Asia, respectively, for patients with your type of NSCLC.

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    Phase 2, Parallel-Arm Study of MGCD265 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Activating Genetic Alterations in Mesenchymal- Epithelial Transition Factor

    The main purpose of this study is to test whether subjects with lung cancer, with specific changes in the tumor genes, benefit from getting study drug, MGCD265.  Other objectives of the study include assessing the side effects of MGCD265 in subjects, and how much and how quickly drug is absorbed and cleared from the blood stream.

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    Osteoarthritis


    A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-02 (Disodium Zoledronate Tetrahydrate) Administered Orally to Subjects with Knee Osteoarthritis Associated with Bone Marrow Lesions.

    This is a phase 3 trial for the treatment of knee osteoarthritis associated with bone marrow lesions. The purpose of the study is to determine whether a study medication, AXS02 (disodium zoledronate tetrahydrate) can reduce bone marrow lesions, and therefore alleviate pain associated with osteoarthritis of the knee. AXS02 is an investigational drug and subjects are monitored to see if it causes any adverse event. Maximum participation is 21 weeks and may include up to 14 visits to Tufts Medical Center. A total of approximately 346 subjects are planned for enrollment. Subjects who are eligible for the study will receive AXS02 or placebo during visits 4-8 (1 tablet per week for 6 weeks). The following 6 visits consist of a number of tests and procedures to gather data.

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    Ovarian Cancer


    A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer

    The purpose of this study is to compare the effect on ovarian cancer of using either olaparib by itself or the combination of cediranib and olaparib to the usual chemotherapy given for ovarian cancer.

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    A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb-003) in Combination with Carboplatin plus Paclitaxel or Carboplatin plus Pegylated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer

    This research is being done to find out if carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin (PLD), chemotherapies (anticancer drugs) that are used to treat ovarian cancer, work better alone or when given with an investigational drug called farletuzumab.

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    Can diet and physical activity modulate ovarian, fallopian tube and primary peritoneal cancer progression-free survival?

    The purpose of this study is to find out if a change in diet and exercise in women with ovarian, fallopian tube, or primary peritoneal cancer has an effect on the length of time someone is cancer free following initial treatment. Some studies suggest diet and exercise may improve survival for cancer patients, but no studies have been done to show if changes in diet and exercise can have an effect on cancer returning in women treated for ovarian, fallopian tube, or primary peritoneal cancer. Other goals include finding out if the changes in diet and exercise will improve your overall quality of life and your ability to be physically active. In addition, you may be asked if researchers can test some of your blood to measure carotenoid levels, which will tell them about the kind of foods you are eating, and examine your genes (DNA).

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    Pancreatic Cancer


    Nab-Paclitaxel (Abraxane®) Plus Gemcitabine In Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-Label, Multi-Center, Phase 2 Study (LAPACT)

    This clinical study is in subjects with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment.

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    Parkinson's Disease


    Observational Study In Parkinson’s Patient Volunteers To Characterize Digital Signatures Associated With Motor Portion Of The Updrs, Daily Living Activities And Speech

    This study is looking at how sensor, audio, and video recordings can be used to identify unique characteristics that can be compared and monitored in patients with Parkinson’s disease.

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    Polycystic Kidney Disease


    Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease

    This study will involve patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and is supported by the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Program. The study has started at Tufts Medical Center and the University of Maryland (Baltimore). Drs. Ronald Perrone and Dana Miskulin of Tufts Medical Center and Drs. Terry Watnick and Steve Seliger of the University of Maryland will conduct the study at these clinical sites. The study will test the safety and tolerability of the antidiabetic drug metformin, which has been shown in animal models to slow the progression of PKD. Metformin is a widely used generic drug that is FDA approved for the treatment of diabetes.

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    Respiratory Distress Syndrome in Premature Infant


    Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome

    The goal of this study is to assess the effectiveness of a new drug, rhCC10, on respiratory outcomes of premature infants with Respiratory Distress Syndrome.

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    Seizures


    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects with Super-Refractory Status Epilepticus

    The purpose of the study is to find out if SAGE-547 has any effect on continuous seizures and if it is safe to use in patients in super-refractory status epilepticus (SRSE). SAGE-547 Injection (SAGE-547) is an investigational drug being studied in patients with continuous seizures (seizures that have little or no break between them) that do not respond to seizure medications.

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    Stroke


    A Phase 2, Placebo Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of BMS-986141 For the Prevention of Recurrent Brain Infarction in Subjects receiving Acetylsalicylic Acid (ASA) following Acute Ischemic Stroke or Transient Ischemic Attack

    The purpose of this study is to determine if the study drug, BMS-986141, is safe and prevents a future stroke when given daily to subjects who have experienced acute ischemic stroke or transient ischemic attack (TIA) and are also taking acetylsalicylic acid (also known as aspirin or ASA).

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    Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS) comparing rivaroxaban 15 mg once daily with aspirin 100 mg

    The purpose of this study is to find out whether a new anti-clotting medication called rivaroxaban leads to fewer blood clots in your brain (stroke) or in other blood vessels in your body when compared with aspirin.

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    Stroke Hyperglycemia Insulin Network Effort Trial

    The purpose of this study is to find out the effects of controlling blood sugar within a narrow range by giving IV insulin in patients with high blood sugar within 12 hours of developing symptoms of a stroke. The study is to determine if giving IV insulin to people with high blood sugar and who have had a stroke can improve recovery as compared to those who receive insulin by an injection under the skin. Studies have shown that high blood sugar levels during a stroke could be associated with more damage to the brain than normal blood sugar levels. Blood sugar levels can be lowered with insulin. The five different insulins that will be used in this study are approved by the FDA and are approved for this use as well. A subject will be assigned to one of 2 study groups: IV insulin and subcutaneous insulin. The subject will have a 50% chance to be assigned in one of the two groups by an internet-based randomization system.

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    Transient Ischemic Attack


    A Phase 2, Placebo Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of BMS-986141 For the Prevention of Recurrent Brain Infarction in Subjects receiving Acetylsalicylic Acid (ASA) following Acute Ischemic Stroke or Transient Ischemic Attack

    The purpose of this study is to determine if the study drug, BMS-986141, is safe and prevents a future stroke when given daily to subjects who have experienced acute ischemic stroke or transient ischemic attack (TIA) and are also taking acetylsalicylic acid (also known as aspirin or ASA).

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