A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia

Brief summary

This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, 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 than 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.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

status

ACTIVE_NOT_RECRUITING

phase

PHASE3

study type

INTERVENTIONAL

enrollment

6720

sponsor

National Cancer Institute (NCI)

conditions

B Acute Lymphoblastic Leukemia; B Lymphoblastic Lymphoma; Down Syndrome

interventions

DRUG: Asparaginase Erwinia chrysanthemi; BIOLOGICAL: Blinatumomab; DRUG: Cyclophosphamide; DRUG: Cytarabine; DRUG: Dexamethasone; DRUG: Doxorubicin Hydrochloride; DRUG: Leucovorin Calcium; DRUG: Mercaptopurine; DRUG: Mercaptopurine Oral Suspension; DRUG: Methotrexate

start date

2019-07-03

start date type

ACTUAL

primary completion date

2027-09-30

has results

false

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters