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

Universitätsklinikum Hamburg-Eppendorf

Status and phase: Completed; Phase 2

Conditions: Myelofibrosis

Treatments: Procedure: Allogeneic Stem Cell Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00599547

EBMT AlloRIC-MMM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Allogeneic Stem Cell Transplantation

Experimental group

Description:

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

Treatment:

Procedure: Allogeneic Stem Cell Transplantation