Northwell Health
Phase I-II studying post transplant cyclophosphamide, bortezomib and sitagliptin for GvHD prevention in allogeneic HSCT. Adults with hematologic malignancies undergoing an RIC allogeneic PBSC transplant from a 5/6 or 6/6 sibling or 7/8 or 8/8 matched unrelated donor.
The phase I portion of the clinical trial, which will define the MTD of sitagliptin, bortezomib, and PTCy as GvHD prophylaxis after reduced-intensity allogeneic PBSC transplantation. Dose escalation will follow a traditional 3+3 design. We will first test the drugs at full doses and sequentially de-escalate the doses of sitagliptin, and then bortezomib, in successive cohorts if a DLT is observed using a 3+3 design. The phase II portion is an open-label, single-arm, Simon two-stage minimax phase II trial design. Patients will receive RIC with fludarabine, busulfan (rATG in unrelated donor gra…
Inclusion Criteria: 1. Patients with any of the following hematologic malignancies: 1. AML in first remission (CR1) if they have intermediate- or high-risk cytogenetic and/or molecular features, or patients in second or subsequent complete remission (CR2, CR3, etc.). Complete remission is defined as presence of \<5% blasts in the bone marrow with no morphological evidence of leukemia. Patients in CR with incomplete count recovery may be included. 2. ALL with any of the following in CR1 or subsequent complete remission (CR2, CR3, etc.). Complete remission is defined as presence of \<5%…
Interventional, non-randomized, open-label, phase I/II study. Phase I: 3+3 phase dose de-escalation; phase II: Simon two-stage minimax.
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