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 transplantatio
- Conditions
- Myelofibrosis, primary, post-ET, post PV-MF<br />Allogeneic stem cell transplantation<br />Myelofibrose<br />Allogene stamceltransplantatie
- Registration Number
- NL-OMON21596
- Lead Sponsor
- HOVON<br>VU University Medical Center,<br>P.O.Box 7057<br>1007 MB Amsterdam<br>The Netherlands<br>tel: +31 20 4442124<br>tel: +31 20 4449086<br>Fax: +31 20 4443566
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
Patients with a confirmed diagnosis of post-ET, post-PV or primary myelofibrosis (Appendix A)
- Intermediate-2 or high-risk according to DIPSS plus
(Appendix E)
Exclusion Criteria
- Previous treatment with JAK2 inhibitors within 2 weeks
of study inclusion. Patients who have been treated with
pacritinib as their previous JAK2 inhibitor treatment
cannot participate in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint<br /><br>♦ Proportion of patients receiving allo-SCT, with failure within or<br>at day 180 post-transplant. Events that are considered a failure<br>are:<br /><br>o Primary graft failure<br /><br>o Acute graft versus host disease grade 3-4<br /><br>o Secondary graft failure<br /><br>o Death, from any cause
- Secondary Outcome Measures
Name Time Method Secondary endpoints<br /><br>♦ Adverse events<br /><br>♦ Proportion of patients receiving allo-SCT<br /><br>♦ Response rate (≥ PR) (see appendix B)<br /><br>♦ Progression free survival (PFS, i.e. time from either<br>registration or allo-SCT until progression/relapse or death from<br>any cause, whichever comes first)<br /><br>♦ Overall survival (OS) calculated from either registration or allo-<br>SCT. Patients still alive or lost to follow up are censored at the<br>date they were last known to be alive<br /><br>♦ Relapse mortality (RM), i.e. death due to the disease or after<br>progression<br /><br>♦ Non-relapse mortality (NRM)<br /><br>♦ Quality of Life during/after treatment