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Enzyme

Blinatumomab + Chemotherapy for Leukemia

Phase 3
Waitlist Available
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5.3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

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.
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.
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
Select...
I was diagnosed with B-ALL or B-LLy at an age that meets the trial's criteria, and I have Down syndrome.
Select...
I have been diagnosed with B-cell ALL or B-cell LLy, with or without Down syndrome.
Select...
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:
Select...
I do not have specific conditions like T-Lymphoblastic Lymphoma, CNS disease, or am pregnant.
Select...
I do not have CNS3, testicular leukemia, or AUL.
Select...
My ALL did not develop after treatment for another cancer.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Defecation
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3330
Mercaptopurine
2012
Completed Phase 4
~12550
Prednisolone
2005
Completed Phase 4
~3570
Radiation Therapy
2017
Completed Phase 3
~7250
Dexamethasone
2007
Completed Phase 4
~2650
Prednisone
2014
Completed Phase 4
~2500
Thioguanine
2012
Completed Phase 4
~10830
Vincristine Sulfate
2005
Completed Phase 3
~10270
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Leucovorin Calcium
2011
Completed Phase 3
~12500
Pegaspargase
2005
Completed Phase 3
~9260
Methotrexate
2019
Completed Phase 4
~4400
Blinatumomab
2014
Completed Phase 3
~1230
Cyclophosphamide
2010
Completed Phase 4
~2310

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,925 Previous Clinical Trials
41,011,281 Total Patients Enrolled
12 Trials studying Down Syndrome
11,951 Patients Enrolled for Down Syndrome
Sumit GuptaPrincipal InvestigatorChildren's Oncology Group
~2331 spots leftby Sep 2027
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