OncRef

Clinical Trial: NCT04669210

PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:St. Petersburg State Pavlov Medical University
Information Provided By:St. Petersburg State Pavlov Medical University
Last Update Posted:2025-07-04

Study Overview

Brief Summary

This is multicenter investigator-initiated randomized open-label phase II clinical trial to compare prophylaxis of graft versus host disease treated with tacrolimus and mycophenolate mofetil versus ruxolitinib after post-transplant cyclophosphamide.

In total 128 patients will be included in the study. After inclusion into the study and performing of transplantation patients will be randomized in 1:1 proportion in two arms (64 patients per arm): arm A will include patients who will be treated with cyclophosphamide and ruxolitinib for GVHD prophylaxis; arm B will include patients who will be treated with cyclophosphamide, tacrolimus and MMF for GVHD prophylaxis. After the end of the treatment patients will be followed-up during two years.

Official Title

A Randomized, Multicenter, Open-label Phase II Trial to Compare Prophylaxis of Graft Versus Host Disease With Tacrolimus and Mycophenolate Mofetil Versus Ruxolitinib After Post-transplant Cyclophosphamide

Conditions

Graft-versus-host-disease, Stem Cell Transplant Complications, Acute Myeloid Leukemia, Acute Lymphoid Leukemia

Intervention / Treatment

  • Drug: Ruxolitinib
  • Drug: Tacrolimus
  • Drug: Mycophenolate Mofetil

Other Study ID Numbers

  • CINC424ARU01T

Start Date (Actual)

2020-11-03

Primary Completion Date (Actual)

2023-02-27

Study Completion Date (Actual)

2025-03-28

Enrollment (Actual)

128

Study Type

Interventional

Phase

Phase 2