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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00599547
First received: January 11, 2008
Last updated: January 13, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Myelofibrosis
Procedure: Allogeneic Stem Cell Transplantation
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:


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: November 2002
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allogeneic Stem Cell Transplantation
Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients
Procedure: Allogeneic Stem Cell Transplantation
Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00599547     History of Changes
Other Study ID Numbers: EBMT AlloRIC-MMM 
Study First Received: January 11, 2008
Last Updated: January 13, 2016
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 December 05, 2016