A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed
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, whi
| Condition(s) | Down Syndrome, Recurrent B Acute Lymphoblastic Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 ca |
| Who can participate | Inclusion Criteria: * Patients must be \>= 1 and \< 31 years at time of enrollment * Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories: * Isolated bone marrow relapse * Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse * Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes * Patients with Down syndrome (DS) are eligible in the following categories: * Isolated bone marrow relapse * Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse * Patients must have a performance status corresponding to Eastern Cooperative Oncology G |
| Ages | 1 Year to 30 Years |
| Sex | All |
| Lead sponsor | National Cancer Institute (NCI) |
| Locations | Birmingham, Alabama, United States; Mobile, Alabama, United States; Anchorage, Alaska, United States; Kingman, Arizona, United States; Mesa, Arizona, United States; Phoenix, Arizona, United States (+219 more sites) |
| Start date | 2020-12-17 |
| NCT ID | NCT04546399 |
| Official listing | https://clinicaltrials.gov/study/NCT04546399 |