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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myelofibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Allogeneic Stem Cell Transplantation

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

Group Type EXPERIMENTAL

Allogeneic Stem Cell Transplantation

Intervention Type PROCEDURE

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

Interventions

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Allogeneic Stem Cell Transplantation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No