NCT02806375

PTCy and Ruxolitinib GVHD Prophylaxis in Myelofibrosis

Graft-versus-host Disease Prophylaxis With Post-transplantation Cyclophosphamide and Ruxolitinib in Patients With Myelofibrosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: St. Petersburg State Pavlov Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Myelofibrosis
• Myeloproliferative Disorders

Interventions

Type	Name	Description
PROCEDURE	Allogeneic hematopoietic stem cell transplantation	Day 0: Infusion of unmanipulated graft
DRUG	Busulfan	Days -5 through -3: Busulfan 1 mg/kg po qid №10
DRUG	Fludarabine monophosphate	Days -7 through -2: 30 mg/m2/day iv qd x 6 days
DRUG	Cyclophosphamide	Day +3 and +4: 50 mg/kg/day iv qd
DRUG	Ruxolitinib	Days -8 through -2 15 mg tid
DRUG	Ruxolitinib	Days +5 through +100: 7.5 mg bid

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-12-01
• Completion: 2019-04-01
• First posted: 2016-06-20
• Last updated: 2019-04-04

Locations

1 site across 1 country: Russia