Trials / Not Yet Recruiting
Not Yet RecruitingNCT07447817
Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias
Investigator-Initiated, Open-Label, Phase II Trial of Selinexor in Combination With Pacritinib in Patients With Myelofibrosis Who Are JAK Inhibitor-Naïve and Have Cytopenias (ILLUMINATE)
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- Sponsor
- John Mascarenhas · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase II, multicenter, open-label trial evaluating the safety and efficacy of pacritinib and selinexor in JAK inhibitor naïve patients with anemia and thrombocytopenia.
Detailed description
This Phase II, multicenter, open-label will evaluate the safety and efficacy of pacritinib and selinexor in JAK inhibitor naïve patients with anemia and thrombocytopenia. Participants will receive pacritinib monotherapy for 1 cycle (4 weeks) and will be assessed for qualification to proceed to combination therapy at Cycle 2 Day 1. Participants who qualify for combination therapy will receiving pacritinib and selinexor for the remaining cycles. Participants who do not qualify at Cycle 2 Day 1 will have weekly assessments and count checks. If they meet criteria for combination therapy at any point, selinexor will be added onto pacritinib. Participants who do not qualify for combination therapy by Cycle 4 Day 1 will complete 6 cycles of pacritinib monotherapy, complete primary endpoint assessments after 24 weeks, and discontinue study participation. Participants receiving combination therapy must demonstrate clinical benefit at Cycle 7 Day 1 (24 weeks) to continue receiving therapy until loss of response, disease progression, unacceptable toxicity, participant/physician withdrawal, or the study is terminated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pacritinib | Pacritinib 200mg twice a day (BID) by mouth (PO) |
| DRUG | Selinexor | Selinexor 60mg once weekly (QW) by mouth (PO) |
Timeline
- Start date
- 2026-05-04
- Primary completion
- 2030-05-24
- Completion
- 2030-05-24
- First posted
- 2026-03-04
- Last updated
- 2026-03-18
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07447817. Inclusion in this directory is not an endorsement.