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 Ruxolitinib induction therapy with patients who lack a suitable stem cell donor and will continue to receive Ruxolitinib.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. 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
2. Patients age: 18 - 70 years at time of inclusion (female and male)
3. Patients understand and voluntarily sign an informed consent form
4. Platelet count ≥ 50 x 109/L
5. No prior Ruxolitinib treatment
6. ECOG ≤ 2
Exclusion Criteria:
1. 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
2. Positive serology for HIV
3. Pregnant or lactating women (positive serum pregnancy test)
4. Age \< 18 and ≥ 71 years.
5. Uncontrolled invasive fungal infection at time of screening (baseline)
6. Serious psychiatric or psychological disorders
7. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
8. Transformation to AML
Primary outcome measure(s)
Event free survival — 3 years Compare to event free survival of patients at 3 years after allogeneic SCT and in Ruxolitinib continuous therapy in patients without a suitable donor
Trial sites (14)
Facility
City
Region
Status
Universitätsklinkum Aachen
Aachen
Germany
HELIOS Klinikum Berlin-Buch
Berlin
Germany
Universitätsklinikum Bonn
Bonn
Germany
Universitätsklinikum Düsseldorf
Düsseldorf
Germany
Universitätsklinkum Halle
Halle
Germany
University Medical Center Hamburg-Eppendorf
Hamburg
Germany
Universitätsklinikum Jena
Jena
Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz
Germany
Johannes Wesling Klinikum Minden
Minden
Germany
Universitätsklinikum Münster
Münster
Germany
Klinikum Nürnberg
Nuremberg
Germany
Robert-Bosch-Krankenhaus Stuttgart
Stuttgart
Germany
Universitätsmedizin Tübingen
Tübingen
Germany
Universitätsklinkum Ulm
Ulm
Germany
More Universitätsklinikum Hamburg-Eppendorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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