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

NCT04669210 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-07-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • St. Petersburg State Pavlov Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2023-02-27
Completion
2025-03-28

Countries

  • Russia

Study Locations

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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 NCT04669210 on ClinicalTrials.gov