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.
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.
ALL with any of the following in CR1 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.
MDS with a revised International Prognostic System Score (IPSS-R) of greater than 3 at diagnosis. Patients must have <10% blasts in the bone marrow documented within 30 days of transplant.*
Therapy-related myelodysplastic disorder (t-MDS). Patients must have <10% blasts in the bone marrow documented within 30 days of transplant.*
Pregnant or nursing females or women of reproductive capability who are unwilling to completely abstain from heterosexual sex or practice effective methods of contraception from start of conditioning through a minimum of 90 days after the last dose of study drug. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 consecutive months.
Male subjects who refuse to practice effective barrier contraception from the start of conditioning through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized (i.e., post- vasectomy).
Inability to provide informed consent.
Patient had myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
Sequential
Post transplant cyclophosphamide, bortezomib and sitagliptin in 3+3 design to MTD
DrugInterventional, non-randomized, open-label, phase I/II study. Phase I: 3+3 phase dose de-escalation; phase II: Simon two-stage minimax.
Phase I
Phase I portion is determining the MTD of sitagliptin and bortezomib in combination with PTCy. Based on 3 planned dose levels, a maximum of 18 patients are included, although testing all three dose levels is not expected to be required.
Phase II
Phase II study is the incidence of grade II-IV acute GvHD by day +100
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