Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia

Conditions

• Leukemia, Myelomonocytic, Chronic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pacritinib — DRUG
  100-mg capsules
• Hydroxyurea — DRUG
  capsules or tablets

Study Details

The goal of this clinical trial is to learn if pacritinib works better than hydroxyurea to treat advanced proliferative chronic myelomonocytic leukemia in adults. The main questions it aims to answer are: * Does pacritinib improve disease control compared to hydroxyurea? * What medical problems do participants have when taking pacritinib or hydroxyurea? Researchers will compare pacritinib to hydroxyurea to see if pacritinib is more effective and better tolerated in people with advanced proliferative chronic myelomonocytic leukemia. Participants will be randomly assigned to receive either pacritinib twice a day or hydroxyurea for up to 48 weeks. After treatment ends, participants will be followed for up to one year.

Key Dates

Start date

Jan 1, 2026

Status verified

Mar 2026

Primary completion

Jul 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

66 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pacritinib
  Pacritinib 200 mg twice daily
• Active Comparator: Hydroxyurea
  Hydroxyurea at doses up to 4 g daily

Primary Outcome Measure

Clinical benefit at Week 24, defined as achieving erythroid response in the absence of leukemic transformation. [ Time Frame: Measured from Week 24 through the end of treatment, up to 48 weeks. ]

Central Contacts

• Zach Albaugh
  [email protected]
• Melissa Fischer
  [email protected]

Locations (4)

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