Allogeneic Stem Cell Transplantation (SCT) After Dose-reduced Conditioning for Myelofibrosis Patients

Phase 2

Completed

• Conditions: Myelofibrosis
• Interventions: Procedure: Allogeneic Stem Cell Transplantation

• Registration Number: NCT00599547
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation is a feasible and effective treatment for patients with primary myelofibrosis.

Detailed Description

The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from related or unrelated donors is a feasible and effective treatment for patients with primary myelofibrosis.

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-01-23
• Primary Completion: 2009-08
• Study Completion: 2009-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Disease: Histologically proven Myelofibrosis with myeloid metaplasia/MMM defined as per the Italian Consensus Conference on MMM diagnosis with either primary MMM or secondary to Polycythaemia vera or essential thrombocythaemia with

  • "intermediate risk" or "high risk" score according to the Lille Scoring System
  • OR "low risk" score according to the Lille Scoring System with constitutional symptoms (fever, night sweat, weight loss > 5% of body weight)
  • OR "high risk" score according to the Cervantes score

• Age:

  • Patients between 50 and 70 years of age and no limited life expectancy for other reasons than MMM
  • Patients under 50 years of age who are not eligible for a standard myeloablative conditioning, (e.g., because of prior autologous stem cell, history of severe infections like fungal infections, history of cardiac toxicity or other reasons according to the treating physician)

• HLA compatible or identical donor, related or unrelated (one mismatch allowed)

• Written informed consent of the patient

Exclusion Criteria

• Positive search for bcr-abl on blood.
• Serious irreversible renal, hepatic, pulmonary or cardiac disease
• Central nervous involvement
• Positive serology for HIV
• Pregnant or lactating women
• Patients with a life-expectancy of less than six months because of another debilitating disease
• Serious psychiatric or psychological disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allogeneic Stem Cell Transplantation	Allogeneic Stem Cell Transplantation	Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients

Primary Outcome Measures

Name	Time	Method
Transplant-related mortality by day +100 and by one year post-transplant, hematopoietic recovery by day +100 post-transplant, myeloid and T-cell chimerism by day +100 posttransplant, toxicity of the regimen acc. to Bearman scale	Follow-up until day +1095

Secondary Outcome Measures

Name	Time	Method
VOD-Staging and VOD-Grading acc. to the McDonald-scale, incidence of GvHD, overall survival post-transplant, disease-free survival post-transplant	Follow-up until day +1095

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany