Trials / Completed

CompletedNCT04669210

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

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

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 128 (actual)

Sponsor: St. Petersburg State Pavlov Medical University · Academic / Other
Sex: All
Age: 18 Years – 70 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
DRUG	Ruxolitinib	Ruxolitinib administered during conditioning 5 mg tid before allogeneic hematopoietic stem cell transplantation, 5 mg tid days 5-21 and 5 mg bid days 22-150 after transplantation instead of tacrolimus and MMF.
DRUG	Tacrolimus	Tacrolimus 0.03 mg/kg adjusted to concentrations 5-15 ng/ml from day+5 to +100
DRUG	Mycophenolate Mofetil	Mycophenolate mofetil 30 mg/kg from day +5 to +35

Timeline

Start date: 2020-11-03
Primary completion: 2023-02-27
Completion: 2025-03-28
First posted: 2020-12-16
Last updated: 2025-07-04

Locations

2 sites across 1 country: Russia

Source: ClinicalTrials.gov record NCT04669210. Inclusion in this directory is not an endorsement.