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Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia

Study acronym: PROSPERA
StatusRecruiting
PhasePhase 2
SponsorTheradex
Started2026-01-01
View on ClinicalTrials.gov ↗

Amendment history

2026-08-17
Study Status, Contacts/Locations v4
Study sites4→6
2026-03-03
Study Status, Contacts/Locations v3
Study sites1→4
2026-02-03
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12→confirmed 2026-01-01
Collaborators2 to 3 entries
MDS/MPN International Working Group (UK Sponsor)
2025-08-15
Study Status, Sponsor/Collaborators v1
Collaborators1 to 2 entries
H. Lee Moffitt Cancer Center and Research Institute
2025-06-13
Original filing
Theradex
1 trial monitored
See all monitored trials
Leukemia
2,553 trials monitored
See 134 trials at risk
MDS/MPN Overlap
180 trials monitored
See 13 trials at risk
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.
Trial Details
NCT Number NCT07033598
Lead Sponsor Theradex
Collaborators: MDS/MPN International Working Group (UK Sponsor), Sobi, Inc., H. Lee Moffitt Cancer Center and Research Institute
Conditions Leukemia, Myelomonocytic, Chronic
Enrollment 66 participants
Start Date 2026-01-01
Primary Completion 2028-07 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-18