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Title A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)
Therapeutic Area Leukemias (Pediatric), Lymphomas
Principal Investigator Jason Law, MD
Min Age 1 Years
Max Age 31 Years
Gender Male and Female
Contact NCCCR
More Information


This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with or without Down syndrome and newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma. Monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, 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. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better then combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.

Study Details

Inclusion Criteria

  • All B-ALL patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 and MUST submit eligibility studies.

  • Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate.

  • B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment).

Exclusion Criteria

  • Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy.
  • With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731.
  • Patient must not have acute undifferentiated leukemia (AUL).

Study Requirements

All patients will receive a common Induction regimen with the exception of children with DS who will also receive 2 doses of oral leucovorin following each dose of intrathecal methotrexate, and age-based steroid treatment that includes either dexamethasone for 28 days (for patients aged <10 years) or predniSO(LO)ne for 28 days (for patients aged ≥10 years). Patients with B-LLy and DS B-LLy will be approached with a single consent prior to starting Induction therapy, which describes all therapy to be received on study. DS B-LLy patients will also receive Induction treatment that includes either dexamethasone for 28 days (for patients aged <10 years) or predniSO(LO)ne for 28 days (for patients aged ≥10 years). Patients with B-LLy and DS B-LLy will be consented to treatment for the duration of the study at enrollment.


At the end of Induction, after B-ALL patients have been stratified into risk subgroups, a second consent that describes all post-Induction therapy will be discussed with patients and their families. There are separate post-Induction consents for children with SR-Fav B-ALL (including DS patients), SR-Avg B-ALL (including DS patients), SR-High B-ALL, and DS-High B-ALL. For patients with SR-Fav B-ALL, the post-Induction consent describes standard chemotherapy that will be administered on this study. For patients with SR-Avg and SR-High subsets of NCI SR B-ALL, the post-Induction consent describes the assignment to post-Induction chemotherapy and the possible randomization to 1 of 2 different post-Consolidation regimens. For patients with DS-High B-ALL the post-Induction consent describes the non-random therapy including three cycles of blinatumomab.


Patients will have physical exams, blood tests, and bone marrow evaluations at various time points throughout the study. Patients will be followed for five years following the end of treatment.