Pacritinib in CMML

Part of paid clinical trials in New York, New York.

Sponsor
Douglas Tremblay
Study ID
NCT06159491
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Chronic Myelomonocytic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 18, 2024
Status verified
Aug 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pacritinib in combination with Azacitidine
    Participants will take pacritinib 200 mg BID for each 28 day cycle, azacitidine 75mg/m2 will be administered IV or SQ QD D1-7 of each 28 day cycle

Primary Outcome Measure

Dose-limiting toxicity of Pacritinib in combination with Azacitidine [ Time Frame: at the end of one 28-day cycle ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Mount Sinai HospitalNew YorkNew York10029
Tina Czaplinska
[email protected]
917-841-2454
Katherine Vandris
[email protected]
917-841-2454
Douglas Tremblay (PRINCIPAL_INVESTIGATOR)

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By research site
The Mount Sinai Hospital· New York, NY

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