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

Conditions

• GVHD - Graft-Versus-Host Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Post transplant cyclophosphamide, bortezomib and sitagliptin in 3+3 design to MTD — DRUG
  Interventional, non-randomized, open-label, phase I/II study. Phase I: 3+3 phase dose de-escalation; phase II: Simon two-stage minimax.

Study Details

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.

Key Dates

Start date

Jul 1, 2026

Status verified

Jun 2026

Primary completion

Jul 1, 2030

Completion

Jul 1, 2032

Study Design

Enrollment

72 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: Dose Level -2
  Dosing for MTD: PTCy 50 mg/kg (day +3, +4), bortezomib 1 mg/m2 (day 0, +3), sitagliptin 400 mg (every 12 hours. day -1 to day +14)
• Experimental: Dose Level -1
  Dosing for MTD: PTCy 50 mg/kg (day +3, +4), bortezomib 1.3 mg/m2 (day 0, +3), sitagliptin 400 mg (every 12 hours. day -1 to day +14)
• Experimental: Dose Level 1
  Dosing for MTD: PTCy 50 mg/kg (day +3, +4), bortezomib 1.3 mg/m2 (day 0, +3), sitagliptin 600 mg (every 12 hours. day -1 to day +14)

Primary Outcome Measure

Phase I [ Time Frame: 6 months ]

Central Contacts

• Kelli Cole, MSN, FNP-BC
  15167348973
  [email protected]

Locations (1)

Find similar trials in New Hyde Park, NY