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PTCy and Ruxolitinib GVHD Prophylaxis in Myelofibrosis

NCT02806375 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-04-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • St. Petersburg State Pavlov Medical University

    lead OTHER

Principal Investigators

  • Boris V. Afanasyev, Professor · St. Petersburg State Pavlov Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-12-31
Completion
2019-04-30

Countries

  • Russia

Study Locations

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Entities

Drugs

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 NCT02806375 on ClinicalTrials.gov