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Completed

NCT Number: NCT00599547

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

allogeneic stem cell transplantation

Procedure

Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Jan 23, 2008
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.