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Clinical Trials in Germany / NCT03333187
Active, not recruiting Phase 2

Ruxolitinib vs Allogeneic SCT for Patients With Myelofibrosis According to Donor Availability

NCT03333187 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2016-12-21
Last updated
2025-03-30

Condition(s) studied

Bone Marrow Fibrosis

Investigational drug(s) / intervention(s)

Allogeneic stem cell transplantationRuxolitinib continuous therapy →

Study 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 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)

Trial sites (14)

FacilityCityRegionStatus
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

Official registry record

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.

View NCT03333187 on ClinicalTrials.gov ↗ ← All trials in Germany