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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00599547
First received: January 11, 2008
Last updated: October 21, 2008
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Myelofibrosis
 Procedure: allogeneic HSCT
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Stem Cell Transplantation After Dose-Reduced Intensity Conditioning Regimen for Patients With Myelofibrosis With Myeloid Metaplasia (MMM): A Phase II-Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 106
Study Start Date: January 2003
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: allogeneic HSCT
    dose-reduced conditioning
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599547

Locations
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Nicolaus Kroeger, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided by Universitätsklinikum Hamburg-Eppendorf

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. N. Kroeger, European Group for Blood and Marrow Transplantation
ClinicalTrials.gov Identifier: NCT00599547     History of Changes
Other Study ID Numbers: EBMT AlloRIC-MMM
Study First Received: January 11, 2008
Last Updated: October 21, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Hematopoietic Stem Cell Transplantation

Additional relevant MeSH terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013