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Blinatumomab + Chemotherapy for Leukemia

Phase 3
Led By Sumit Gupta
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age at diagnosis: Patients must meet specific age criteria based on B-ALL or B-LLy diagnosis and presence of Down syndrome.
Patients must meet specific diagnostic criteria for B-cell ALL or B-cell LLy, with or without Down syndrome.
Must not have
Specific exclusion criteria apply for B-cell LLy patients, including T-Lymphoblastic Lymphoma, morphologically unclassifiable lymphoma, absence of both B-cell and T-cell phenotype markers, CNS positive disease or testicular involvement, specific marrow blast percentages, known Charcot-Marie-Tooth disease, known MYC translocation associated with mature (Burkitt) B-cell ALL, requirement for radiation at diagnosis, pregnancy, lactation, and contraceptive use.
Specific exclusion criteria apply for B-ALL patients with central nervous system [CNS]3 leukemia, testicular leukemia, and acute undifferentiated leukemia (AUL).
Screening 3 weeks
Treatment Varies
Follow Up 5.3 years
Awards & highlights


This trial is studying how well blinatumomab works with chemotherapy in treating patients with newly diagnosed B-cell acute lymphoblastic leukemia or B-lymphoblastic lymphoma.

Who is the study for?
This trial is for patients with newly diagnosed B-lymphoblastic leukemia/lymphoma, including those with Down syndrome. Participants must meet specific age and white blood cell count criteria and have not received prior cytotoxic chemotherapy (except certain steroids or intrathecal cytarabine). Exclusions include CNS3/testicular leukemia, secondary ALL from previous cancer treatment, Burkitt B-cell ALL, pregnancy, lactation.Check my eligibility
What is being tested?
The study tests blinatumomab combined with chemotherapy drugs like vincristine and methotrexate in treating standard risk B-ALL/B-LLy. It aims to see if this monoclonal antibody plus chemo improves outcomes compared to chemo alone. Patients are grouped by cancer recurrence risk to tailor the treatment regimen.See study design
What are the potential side effects?
Potential side effects include immune system changes leading to inflammation in organs, allergic reactions from monoclonal antibodies like blinatumomab, common chemotherapy-related issues such as nausea, hair loss, fatigue, increased infection risk and potential harm to liver or kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I was diagnosed with B-ALL or B-LLy at an age that meets the trial's criteria, and I have Down syndrome.
I have been diagnosed with B-cell ALL or B-cell LLy, with or without Down syndrome.
My white blood cell count meets the criteria for someone with B-ALL and Down syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
I do not have specific conditions like T-Lymphoblastic Lymphoma, CNS disease, or am pregnant.
I do not have CNS3, testicular leukemia, or AUL.
My ALL did not develop after treatment for another cancer.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5.3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5.3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DFS in boys in the SR-favorable subset of SR B-ALL with or without Down syndrome (DS)
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
Secondary outcome measures
Caregiver burden as measured by the At-Work Productivity Loss summary score from the Caregiver Work Limitations questionnaire among a subset of children enrolled in the HMH and neurocognitive outcome study
Caregiver burden as measured by the Mean Total score from the Care of My Child with Cancer questionnaire among a subset of children enrolled in the HMH and neurocognitive outcome study
+7 more
Other outcome measures
Association between flow cytometry
Genetic landscape of B-ALL lacking a clonal Ig sequence
Neurocognitive, functional, and quality of life outcomes in patients with DS and ALL
+2 more

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: NCI SR or HR DS B-ALLExperimental Treatment12 Interventions
See detailed description.
Group II: DS B-ALLExperimental Treatment13 Interventions
See detailed description.
Group III: B-LLyExperimental Treatment14 Interventions
See detailed description.
Group IV: Arm D (SR-High experimental)Experimental Treatment15 Interventions
Arm D See detailed description.
Group V: Arm B (SR-Avg experimental)Experimental Treatment13 Interventions
Arm B: See detailed description.
Group VI: Arm C (SR-High Control)Active Control14 Interventions
Arm C: See detailed description.
Group VII: Arm A (SR-Avg control)Active Control13 Interventions
Arm A: See detailed description.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Completed Phase 4
Completed Phase 4
Radiation Therapy
Completed Phase 3
Completed Phase 4
Completed Phase 4
Completed Phase 4
Vincristine Sulfate
Completed Phase 3
Doxorubicin Hydrochloride
Completed Phase 3
Leucovorin Calcium
Completed Phase 3
Completed Phase 3
Completed Phase 4
Completed Phase 3
Completed Phase 3

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,952,681 Total Patients Enrolled
Sumit GuptaPrincipal InvestigatorChildren's Oncology Group
~3332 spots leftby Jun 2029