Phase I Trial of Pacritinib in Combination With Venetoclax and Azacitidine for the Treatment of Accelerated and Blast Phase Myeloproliferative Neoplasms

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT07679334
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Myeloproliferative Neoplasm

Eligibility Criteria

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

Interventions

  • Pacritinib — DRUG
    Subjects will be dosed until MTD is reached
  • Venetoclax — DRUG
    Given PO
  • Azacitidine — DRUG
    Given SC or IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrrow aspiration

Study Details

This phase I trial studies the side effects and best dose of pacritinib when given together with venetoclax and azacitidine in treating patients with accelerated and blast phase myeloproliferative neoplasms (MPN-AP/BP). Pacritinib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving pacritinib together with venetoclax and azacitidine may be safe, tolerable, and/or effective in treating patients with MPN-AP/BP

Key Dates

Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2028
Completion
Aug 1, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm 1
    Pacritinib in combination with venetoclax and azacitidne. Dose will increase until side effects occur or maximum tolerated dose is reached. Additionally, patients undergo MRI or CT as well as bone marrow aspiration and biopsy throughout the trial.

Primary Outcome Measure

To determine the maximum tolerated dose (MTD) of the treatment regimen. [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263
ASK Roswell
[email protected]
800-767-9355
Steven Green, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Roswell Park Comprehensive Cancer Center· Buffalo, NY

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