Back to Results

Randomized Study of Opdivo plus AVD or Adcetris plus AVD in patients with newly diagnosed advanced classical hodgkin lymphoma SWOG 1826


Title A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE >/= 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA
Therapeutic Area Hodgkin Lymphoma
Principal Investigator Jason Law, MD
Min Age 12 Years
Gender Both
Contact NCCCR Staff
617-636-3264
NCCCR@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03907488?term=03907488&draw=2&rank=1

Overview

This is a randomized Phase III study comparing the addition of nivolumab or brentuximab vedotin to a backbone of AVD chemotherapy for the initial treatment of advanced stage Hodgkin lymphoma (HL). In addition to the primary therapeutic objective, a series of quality of life analyses will be conducted to assess the impact of each treatment regimen on patient well-being. The prognostic impact of imaging-based biomarkers like pre-treatment metabolic tumor volume and outcomes based on novel response assessment criteria (i.e. LYRIC and RECIL) that specifically address atypical responses observed with immunotherapy will be studied. Finally, tumor tissue banking and blood for future translational medicine studies will be done

Study Details

Inclusion Criteria

1. Newly diagnosed and previously untreated Stage II or IV Classical Hodgkin Lymphoma

2. Greater than or equal to 12 years of age

3. Patients must have adequate liver and kidney function and no known/active infections or immunodeficiency

Exclusion Criteria

1. Previously received any prior chemotherapy, radiation or antibody based treatment for classical Hodgkin lymphoma

2. Prior solid organ transplant or allogenic stem cell transplantation

3. History of or active interstitial pneumonitis or interstitial lung disease.

Study Requirements

This phase III trial studies how well inotuzumab ozogamicin and post-induction chemotherapy work in treating patients with high-risk B-cell lymphoblastic lymphoma (B-ALL), mixed phenotype acute leukemia, and B-lymphoblastic lymphoma (B-LLy). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, cytarabine, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, thioguanine, vincristine, and pegaspargase, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The goal of the part 1 of the study is to collect information about leukemia and the effects of the first two phases of treatment, called Induction and Consolidation on this cancer. Additionally, this study aims to investigate whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for 3 years from the start of Interim Maintenance in patient with High Risk Favorable (HR-Fav) and HR B-ALL. Another aim is to understand the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) receiving HR B-ALL therapy. Finally, another goal of this study is to determine the outcomes of subjects with Mixed Phenotype Acute Leukemia (MPAL) with a favorable early response to treatment using High Risk B-cell Acute Lymphoblastic Leukemia therapy.