drugset / Trial / NCT03381118
Haploidentical Lymphocytes With Nivolumab/Ara-C as Consolidation in Elderly AML Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
A phase II trial to compare the efficacy and safety of nivolumab and intermediate dose cytarabine with or without haploidentical lymphocyte infusion. To identify the role of haploidentical lymphocytes in the treatment of acute myeloid leukemia in older adults. The patients will be stratified based on the remission number (first or second)
Timeline
- Start
- 2017-06-30
- Primary completion
- 2018-09-30
- Completion
- 2018-09-30
Outcome
Outcome not reported
Stopped: “Unexpected toxicity”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | G-CSF mobilized HLA-haploidentical donor PBSC | Cell therapy | — | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 40 mg | Intravenous |