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

Study Overview
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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.

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.

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

Conditions
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Myelofibrosis

Intervention / Treatment
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* Procedure: Allogeneic Stem Cell Transplantation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allogeneic Stem Cell Transplantation<br>Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients | Procedure: Allogeneic Stem Cell Transplantation<br>* Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic Stem Cell Transplantation