NCT04669210View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

November 3, 2020

Primary Completion Date

February 27, 2023

Study Completion Date

March 28, 2025

Conditions
Graft-versus-host-diseaseStem Cell Transplant ComplicationsAcute Myeloid LeukemiaAcute Lymphoid Leukemia
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

Trial Locations (2)

125167

National Hematology Research Center, Moscow

197022

RM Gorbacheva Research Institute, Saint Petersburg

All Listed Sponsors
lead

St. Petersburg State Pavlov Medical University

OTHER

NCT04669210 - PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT | Biotech Hunter | Biotech Hunter