drugset / Trial / NCT02806375

PTCy and Ruxolitinib GVHD Prophylaxis in Myelofibrosis

NCT02806375

Phase 1/2 Completed 20 enrolled St. Petersburg State Pavlov Medical University
NaSingle-groupOpen-labelTreatment

Summary

A number of groups have demonstrated very low incidence of acute and chronic graft-versus-host disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in haploidentical and unrelated allogeneic stem cell transplantation (SCT). Still the relapse of the underlining malignancy is a problem after this prophylaxis. Ruxolitinib is currently one of the most promising drugs in the treatment of steroid-refractory GVHD. On the other hand, its primary indication is myelofibrosis, and it was demonstrated that ruxolitinib before allogeneic SCT might improve the outcome. This pilot trial evaluates whether the combination of PTCy and ruxolitinib facilitates adequate GVHD control, and decreases the risk of graft failure and disease progression in myelofibrosis patients.

Timeline

Start
2016-01
Primary completion
2018-12
Completion
2019-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Subject Ruxolitinib Small molecule 7.5 mg
Background Busulfan Small molecule 1 mg/kg Oral
Background Fludarabine Small molecule 30 mg/m2 Intravenous

Indications