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High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Sitagliptin for the Prevention of GVHD

NCT05895201 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2024-04-29

No results posted yet for this study

Summary

This is an open label Phase I-II study to determine the safe doses of bortezomib, sitagliptin, and PTCy (Phase I) with expansion into a phase II trial to determine efficacy in improving survival.

Conditions

Interventions

DRUG

Sitagliptin

600 or 400 (or MTD) mg PO every 12 hours on days -1 to +14 depending on dose level assignment.

DRUG

Bortezomib

1.3 or 1.0 mg/m2 (or MTD) IV push 6 hours after graft infusion completion (day 0), and 72 hours thereafter depending on dose level assignment.

DRUG

Cyclophosphamide

50 mg/kg IV over 1 hour on days +3 and +4

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05895201 on ClinicalTrials.gov