Status:
ACTIVE_NOT_RECRUITING
Ruxolitinib vs Allogeneic SCT for Patients With Myelofibrosis According to Donor Availability
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
Novartis
Clinical Trial Center North (CTC North GmbH & Co. KG)
Conditions:
Bone Marrow Fibrosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The present study will be a multicenter, prospective phase II-study comparing efficacy of allogeneic SCT for patients with myelofibrosis who have a suitable stem cell donor after a 3 months Ruxolitini...
Detailed Description
This study is a multicenter, prospective phase II-study compares efficacy of allogeneic SCT for patients with myelofibrosis who have a suitable stem cell donor after a 3 months Ruxolitinib induction t...
Eligibility Criteria
Inclusion
- Symptomatic primary myelofibrosis or myelofibrosis post polycythaemia vera or essential thrombocythemia stage intermediate 2- or high-risk according to IPSS or DIPSS \[46\] or intermediate 1-risk with high risk cytogenetics, other than normal karyotype, sole del 20q, del 13q, or sole+9, or transfusion-dependency
- Patients age: 18 - 70 years at time of inclusion (female and male)
- Patients understand and voluntarily sign an informed consent form
- Platelet count ≥ 50 x 109/L
- No prior Ruxolitinib treatment
- ECOG ≤ 2
Exclusion
- Severe renal, hepatic, pulmonary or cardiac disease, such as:
- Total bilirubin, SGPT or SGOT \> 3 times upper the normal level
- Left ventricular ejection fraction \< 30 %
- Creatinine clearance \< 30 ml/min
- DLCO \< 35 % and/or receiving supplementary continuous oxygen
- Positive serology for HIV
- Pregnant or lactating women (positive serum pregnancy test)
- Age \< 18 and ≥ 71 years.
- Uncontrolled invasive fungal infection at time of screening (baseline)
- Serious psychiatric or psychological disorders
- Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
- Transformation to AML
Key Trial Info
Start Date :
December 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2025
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03333187
Start Date
December 21 2016
End Date
October 7 2025
Last Update
March 30 2025
Active Locations (14)
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1
Universitätsklinkum Aachen
Aachen, Germany, 52074
2
HELIOS Klinikum Berlin-Buch
Berlin, Germany, 13125
3
Universitätsklinikum Bonn
Bonn, Germany, 53105
4
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225