Allogeneic Stem Cell Transplantation After Dose-reduced Intensity Conditioning Regimen for Patients With Myelofibrosis With Myeloid Metaplasia (MMM): A Phase II-study

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country106 target enrollmentNovember 2002

ConditionsMyelofibrosis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Myelofibrosis
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Enrollment: 106
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2002

End Date

December 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Responsible Party

Sponsor

Eligibility Criteria

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
•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

Outcomes

Primary Outcomes

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

Time Frame: Follow-up until day +1095

Secondary Outcomes

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)