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

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ClinicalTrials.gov Identifier: NCT00599547
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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 or disease Intervention/treatment Phase
Myelofibrosis Procedure: Allogeneic Stem Cell Transplantation Phase 2

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  (Clinical Trial)
Actual Enrollment : 106 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2002
Actual Primary Completion Date : August 2009
Actual Study Completion Date : December 2009


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

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

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