Azacitidine Plus Nivolumab Following Reduced-intensity Allogeneic PBSC Transplantation for Patients With AML and High-risk Myelodysplasia
Summary
This is a phase I clinical trial that will define the maximum tolerated dose (MTD) and investigate the feasibility and safety of the combination of nivolumab and azacitidine after reduced-intensity allogeneic PBSC transplantation. Dose escalation will follow a traditional 3+3 design. The investigators will first escalate the dose of single agent nivolumab to determine its MTD (if any, at the doses tested), with an expanded cohort at the MTD or highest dose tested. The investigators will then combine escalating azacitidine in combination of with nivolumab at its determined MTD or highest dose tested in earlier cohorts, and expand the highest dose cohort tested with the combination. Patients will be treated according to the dose level cohorts described in the protocol.
Timeline
- Start
- 2019-10-10
- Primary completion
- 2020-09-28
- Completion
- 2020-09-28
Outcome
Outcome not reported
Stopped (Enrollment): “Funder withdrew funding after not accruing any subjects after 1 year.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 8 mg/m2 | — |
| Subject | Azacitidine | Other / unclassified | 16 mg/m2 | — |
| Subject | Azacitidine | Other / unclassified | 24 mg/m2 | — |
| Subject | Nivolumab | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 0.5 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 1 mg/kg | Intravenous |