PTCy and Ruxolitinib GVHD Prophylaxis in Myelofibrosis

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT02806375
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Myeloproliferative Disorders
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 31, 2016
Status verified
Apr 2019
Primary completion
Dec 31, 2018
Completion
Apr 30, 2019

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PTCy and ruxolitinib

Primary Outcome Measure

Incidence of acute graft-versus-host disease, grades II-IV [ Time Frame: 180 days ]

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