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

Myelofibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599547
• Other study ID #: EBMT AlloRIC-MMM
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2008
• Last updated: January 13, 2016
• Start date: November 2002
• Est. completion date: December 2009

Study information

• Verified date: January 2016
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelofibrosis
• Primary Myelofibrosis

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes