OncoMatch/Clinical Trials/NCT04546399
A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Is NCT04546399 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for down syndrome.
Treatment: Blinatumomab · Calaspargase Pegol · Cytarabine · Dexamethasone · Hydrocortisone Sodium Succinate · Mercaptopurine · Methotrexate · Nivolumab · Pegaspargase · Pegcrisantaspase · Vincristine Sulfate — This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 positive
relapse blasts must express CD19
Excluded: BCR Philadelphia chromosome
Patients with Philadelphia chromosome positive (Ph+) B-ALL
Excluded: MYC translocation
Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL
Disease stage
Required: Stage FIRST RELAPSE
first relapse of CD19+ B-ALL
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: hematopoietic stem cell transplant
Lab requirements
Kidney function
Creatinine clearance or radioisotope GFR >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/sex as specified
Cardiac function
Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by echocardiogram, cardiac MRI or radionuclide angiogram; No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination
Creatinine clearance or radioisotope GFR >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/sex as follows ... Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% ... No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Alabama · Birmingham, Alabama
- USA Health Strada Patient Care Center · Mobile, Alabama
- Providence Alaska Medical Center · Anchorage, Alaska
- Kingman Regional Medical Center · Kingman, Arizona
- Banner Children's at Desert · Mesa, Arizona
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04546399 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hematopoietic stem cell transplant disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Are patients with BCR alterations eligible?
No. BCR Philadelphia chromosome is an exclusion criterion.
Are patients with MYC alterations eligible?
No. MYC translocation is an exclusion criterion.
What disease stage is eligible?
Stage FIRST RELAPSE is required.
Is there an age limit?
Yes. Patients must be 30 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages