Active — Not RecruitingPhase 3

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

United States6,720 participantsStarted 2019-07-03

Plain-language 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.

Who can participate

Age range365 Days – 31 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * Age at diagnosis: * Patients must be \>= 365 days and \< 10 years of age (B-ALL patients without DS). * Patients must be \>= 365 days and =\< 31 years of age (B-ALL patients with DS). * Patients must be \>= 365 days and =\< 31 years of age (B-LLy patients with or without DS). * B-ALL patients without DS must have an initial white blood cell count \< 50,000/uL (performed within 7 days prior to enrollment). * B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment). * Patient has newly diagnosed B-cell ALL, with or without Down syndrome: \> 25% blasts on a bone marrow (BM) aspirate; * OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy; * OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells; * OR patient has newly diagnosed B-cell LLy Murphy stages I or II, with or without Down syndrome. * Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks),…

What they're measuring

Disease free survival (DFS) in randomization eligible patients with higher risk features (SR-High) or standard risk average (SR-Avg) B-ALL patients based on randomization with addition of blinatumomab

Timeframe: 5.3 years

DFS in boys in the SR-favorable subset of SR B-ALL with or without Down syndrome (DS)

Timeframe: 5.1 years

Trial details

NCT IDNCT03914625

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-09-30

View on ClinicalTrials.gov More B Acute Lymphoblastic Leukemia trials