What is this study trying to find out about relapsed B-cell acute lymphoblastic leukemia?

This study is comparing blinatumomab alone to blinatumomab combined with nivolumab in patients with first relapse B-cell acute lymphoblastic leukemia to see which treatment better controls the disease. Researchers want to understand if adding nivolumab improves outcomes like remission and event-free survival. The National Cancer Institute sponsors this research to improve treatment options for this condition.

Who may be eligible for this relapsed B-cell acute lymphoblastic leukemia clinical trial?

Patients between 1 and under 31 years old with first relapse of CD19 positive B-cell acute lymphoblastic leukemia, including those with Down syndrome, may be eligible. Both males and females can participate if they meet health and performance status criteria and have not had a prior stem cell transplant. Please review eligibility criteria for more details.

Is there any cost to participate in this relapsed B-cell acute lymphoblastic leukemia clinical trial?

Study-related care, including medications and all trial visits, is provided at no cost. However, personal expenses like travel or lodging may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 1Year - 30Years

All Genders

ID04546399

A Phase 2 Study of Blinatumomab With or Without Nivolumab in Patients Aged 1 to Under 31 Years With First Relapse of B-Cell Acute Lymphoblastic Leukemia

Led by National Cancer Institute (NCI) · Updated on 2025-09-10

461

Participants Needed

215

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the combination of nivolumab and blinatumomab compared to blinatumomab alone in patients aged 1 to under 31 years with first relapse of CD19 B-cell acute lymphoblastic leukemia B-ALL, including those with Down syndrome. This phase II trial aims to compare event-free survival and remission rates, as well as assess safety and tolerability of these treatments in this patient group. Treatment involves several groups and arms with different combinations of drugs including dexamethasone, blinatumomab, nivolumab, methotrexate, and others. Some groups receive pre-immunotherapy treatments depending on disease characteristics. Treatment cycles last about 36 to 37 days and may repeat up to two cycles unless disease progression or unacceptable toxicity occurs. Radiation therapy and various chemotherapy regimens are also part of the treatment for certain patients. Participants undergo lumbar punctures, bone marrow biopsies and aspirations, and collections of blood, urine, and cerebrospinal fluid throughout the study. After treatment completion, they are followed up every 3 months for 1 year. The main results measured include minimal residual disease-negative remission rates and event-free survival. Safety, adverse events, and other clinical factors are closely monitored during and after treatment.

CONDITIONS

Brief Title

A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Who Can Participate

Age: 1Year - 30Years

All Genders

Eligibility Criteria

You may qualify if you...

Patients aged 1 to under 31 years at enrollment
First relapse of CD19 positive B-cell acute lymphoblastic leukemia in isolated bone marrow, isolated CNS/testicular relapse, or combined bone marrow with CNS/testicular relapse
Patients with Down syndrome with isolated bone marrow or combined bone marrow with CNS/testicular relapse
Performance status score of 0, 1, or 2 using ECOG, Karnofsky (over 16 years), or Lansky (16 years or younger) scales
Fully recovered from prior chemotherapy, immunotherapy, or radiotherapy
Prior blinatumomab or CD19 CAR therapy allowed if relapse blasts express CD19
No prior hematopoietic stem cell transplant
May have had up to five days of steroids or hydroxyurea before enrollment
Adequate kidney function based on creatinine clearance or age/sex-specific serum creatinine
Adequate heart function with shortening fraction ≥27% or ejection fraction ≥50%
No dyspnea at rest and pulse oximetry >94% if clinically indicated
Informed consent signed
Compliance with all institutional, FDA, and NCI human study requirements

You will not qualify if you...

Diagnosis of B-lymphoblastic lymphoma, Burkitt leukemia/lymphoma, mature B-cell leukemia, Philadelphia chromosome positive B-ALL, or mixed phenotype acute leukemia
Known Charcot-Marie-Tooth disease
Known MYC translocation associated with mature B-cell ALL
Active uncontrolled infection including recent positive blood cultures, ongoing antibiotics with symptoms, fever with infection signs, recent fungal infection, or active viral/protozoal infections requiring IV treatment
Known genetic syndromes affecting bone marrow (e.g., Bloom syndrome, Fanconi anemia)
Uncontrolled HIV, hepatitis B or C infections unless well controlled and undetectable
Significant CNS disorders preventing blinatumomab treatment, including severe neurologic or autoimmune disease involving CNS
Active autoimmune disease except certain controlled conditions
Non-hematopoietic, non-CNS/testicular extramedullary disease in Group 4 or Down syndrome patients
Female patients of childbearing potential without negative pregnancy test or effective contraception
Lactating females unwilling to stop breastfeeding during and after treatment

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