NL-OMON47477
Recruiting
Phase 2
A phase II trial in patients with myelofibrosis (primary, post-ET or post PV-MF) treated with the selective JAK2 inhibitor Pacritinib before reduced-intensity conditioning allogeneic stem cell transplantation - HOVON 134 MF
HOVO0 sites65 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- HOVO
- Enrollment
- 65
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients with a confirmed diagnosis of post\-ET, post\-PV or primary
- •myelofibrosis
- •\- Intermediate\-2 or high\-risk according to DIPSS plus
- •\- Age 18\-70 years inclusive
- •\- WHO performance status 0\-2
- •\- Platelet count \>\= 25 × 109/L without platelet support within 2 weeks before
- •study entry.
- •\- All men and women of childbearing potential must agree to use adequate
- •contraception during the study
- •\- Written informed consent
Exclusion Criteria
- •\- Patients who have been treated with pacritinib as their previous JAK2
- •inhibitor treatment cannot participate in this study.
- •\- Previous treatment with JAK2 inhbitors, other than pacritinib, is allowed
- •with the exception of high dose ruxolitinib (above 10 mg BID). For these
- •patients taper the dose to 10 mg BID or lower at least 2 weeks before
- •pacritinib treatment is allowed.
- •\- Any GI or metabolic condition (e.g. inflammatory or chronic functional bowel
- •disorder such as Crohn\*s Disease, Inflammatory Bowel Disease, chronic diarrhea
- •or constipation) that could interfere with absorption of oral medication
- •\- Left ventricular cardiac ejection fraction of \<\= 45% by echocardiogram or
Outcomes
Primary Outcomes
Not specified
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