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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00599547

Enrollment

106

Registered

2008-01-23

Start date

2002-11-30

Completion date

2009-12-31

Last updated

2016-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis

Keywords

Hematopoietic Stem Cell Transplantation

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.

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.

Interventions

PROCEDUREAllogeneic Stem Cell Transplantation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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	Follow-up until day +1095

Secondary

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	Follow-up until day +1095

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026