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

• Status: Active, not recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Clinical Trial Center North (CTC North GmbH & Co. KG); CTC North (CRO); Novartis

Criteria

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