Allogeneic Stem Cell Transplantation (SCT) After Dose-reduced Conditioning for Myelofibrosis Patients
January 13, 2016 updated by: Universitätsklinikum Hamburg-Eppendorf
Allogeneic Stem Cell Transplantation After Dose-reduced Intensity Conditioning Regimen for Patients With Myelofibrosis With Myeloid Metaplasia (MMM): A Phase II-study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
106
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hamburg, Germany, 20246
- University Medical Center Hamburg-Eppendorf
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Allogeneic Stem Cell Transplantation
Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients
|
Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: Follow-up until day +1095
|
Follow-up until day +1095
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
VOD-Staging and VOD-Grading acc. to the McDonald-scale, incidence of GvHD, overall survival post-transplant, disease-free survival post-transplant
Time Frame: Follow-up until day +1095
|
Follow-up until day +1095
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicolaus Kroeger, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
January 11, 2008
First Submitted That Met QC Criteria
January 22, 2008
First Posted (Estimate)
January 23, 2008
Study Record Updates
Last Update Posted (Estimate)
January 14, 2016
Last Update Submitted That Met QC Criteria
January 13, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EBMT AlloRIC-MMM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.