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

Clinical trial · National Cancer Institute (NCI)

- Archive id: nct:NCT03914625
- Published: 2019-04-16
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03914625
- Source URL: https://clinicaltrials.gov/study/NCT03914625
- Provenance: clinicaltrials

## Abstract

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.

_Abstract reproduced under 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._

## 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

Topics: [Cancer Immunotherapy](https://space-kitty.com/topics/cancer-immunotherapy)

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