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Phase I-II PTCy, Bortezomib and Sitagliptin for Prevention of GvHD Following Allogeneic HSCT

NCT07675174 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-06-30

No results posted yet for this study

Summary

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.

Conditions

  • GVHD - Graft-Versus-Host Disease

Interventions

DRUG

Post transplant cyclophosphamide, bortezomib and sitagliptin in 3+3 design to MTD

Interventional, non-randomized, open-label, phase I/II study. Phase I: 3+3 phase dose de-escalation; phase II: Simon two-stage minimax.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2030-07-01
Completion
2032-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07675174 on ClinicalTrials.gov