Nivolumab for High-Risk MDS/AML Patients After Allogeneic Stem Cell Transplant With Post-Transplant Cyclophosphamide
Status:
Withdrawn
Trial end date:
2021-04-20
Target enrollment:
Participant gender:
Summary
There are no strategies developed post-stem cell transplant (SCT) for patients who receive
allogenic SCT with a significant amount of blasts prior SCT. Novel strategies to treat
relapsed AML/MDS and to reduce the incidence of relapse after allogeneic SCT are needed. This
study is being done in patients with high-risk MDS or AML who undergo an allogeneic SCT.
The study will have two arms, participants who receive an HLA-matched unrelated donor SCT
(Arm A) or HLA- haploidentical SCT (Arm B). Following myeloablative conditioning (MAC), GVHD
prophylaxis with post-transplantation cyclophosphamide (PTCy), tacrolimus and mycophenolate
mofetil will be given per standard of care. At 40-60 days post SCT, If the patient has not
had any evidence of Grade II-IV acute graft-versus-host-disease (aGVHD), Nivolumab will be
given intravenously every 2 weeks for 4 cycles of consolidation or treatment with Nivolumab.
Dose-escalation of Nivolumab will follow the standard 3+3 design where a maximum of three
dose levels will be evaluated, with a maximum of 18 patients treated with nivolumab per arm.
As the maximum tolerated dose (MTD) of Nivolumab may differ between Arm A and Arm B, dose
escalation of nivolumab in each arm will be followed separately following allogeneic SCT.
Immunosuppression with tacrolimus will be continued during the cycles of PD-1 blockade to
provide a moderate level of GVHD prophylaxis during consolidation or treatment with
nivolumab.