NCT06159491

Pacritinib in CMML

Pacritinib in Combination With Azacitidine in Patients With Chronic Myelomonocytic Leukemia

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Douglas Tremblay · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2 trial of pacritinib in combination with azacitidine in patients with Chronic Myelomonocytic Leukemia (CMML). Patients will be newly diagnosed or previously treated but could not have received a prior JAK inhibitor. Patients who have previously been treated with a hypomethylating agent (HMA) must have received ≤ 1 cycle. Pacritinib will be initially tested at a dose of 200mg twice daily (dose level 0) in combination with azacitidine 75mg/m2, which can be administered subcutaneously or intravenously, for 7 days in a 28-day cycle. If there are 2 DLTs in the first 6 patients, there will be a dose escalation to pacritinib 100mg twice daily (dose level -1) and an additional 6 patients will be enrolled. Based on the phase 1, 3+3 dose de-escalation design, 6-12 patients will be enrolled in the phase 1 portion. After the completion of phase 1 and identification of the recommended phase 2 dose (RP2D), the trial will then proceed to phase 2 which will employ a Simon two stage design. This portion will include the 6 patients enrolled during the phase 1 portion at the MTD. An interim analysis for futility will occur. If 3 or fewer patients have had a clinical benefit (CB) or better, as defined by 2015 MDS/MPN IWG criteria, the PI and DSMC will meet to discuss the totality of the evidence and determine if the trial shall proceed. In the second stage, an additional 12 patients will be enrolled.

Conditions

• Chronic Myelomonocytic Leukemia

Interventions

Type	Name	Description
DRUG	Pacritinib	Participants will take Pacritinib 100 mg - 200mg BID for each 28 day cycle
DRUG	Azacitidine	Azacitidine 75mg/m\^2 will be administered IV or SQ QD D1-7 of each 28 day cycle

Timeline

• Start date: 2024-09-18
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2023-12-06
• Last updated: 2025-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study