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

Primary Purpose

Myelofibrosis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Allogeneic Stem Cell Transplantation
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelofibrosis focused on measuring Hematopoietic Stem Cell Transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Medical Center Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allogeneic Stem Cell Transplantation

Arm Description

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

Outcomes

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

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

Full Information

First Posted
January 11, 2008
Last Updated
January 13, 2016
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT00599547
Brief Title
Allogeneic Stem Cell Transplantation (SCT) After Dose-reduced Conditioning for Myelofibrosis Patients
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis
Keywords
Hematopoietic Stem Cell Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allogeneic Stem Cell Transplantation
Arm Type
Experimental
Arm Description
Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients
Intervention Type
Procedure
Intervention Name(s)
Allogeneic Stem Cell Transplantation
Intervention Description
Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaus Kroeger, Prof. Dr.
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19812383
Citation
Kroger N, Holler E, Kobbe G, Bornhauser M, Schwerdtfeger R, Baurmann H, Nagler A, Bethge W, Stelljes M, Uharek L, Wandt H, Burchert A, Corradini P, Schubert J, Kaufmann M, Dreger P, Wulf GG, Einsele H, Zabelina T, Kvasnicka HM, Thiele J, Brand R, Zander AR, Niederwieser D, de Witte TM. Allogeneic stem cell transplantation after reduced-intensity conditioning in patients with myelofibrosis: a prospective, multicenter study of the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation. Blood. 2009 Dec 17;114(26):5264-70. doi: 10.1182/blood-2009-07-234880. Epub 2009 Oct 7.
Results Reference
derived

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

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