Pacritinib for Chronic Myelomonocytic Leukemia
(PROSPERA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if pacritinib, a type of medication, is more effective than hydroxyurea in treating advanced proliferative chronic myelomonocytic leukemia, a type of blood cancer. Researchers seek to discover if pacritinib can better control the disease and identify any side effects compared to hydroxyurea. Participants will receive either pacritinib or hydroxyurea randomly for up to 48 weeks. This trial may suit those diagnosed with chronic myelomonocytic leukemia who experience symptoms like an enlarged spleen or low platelet counts. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires stopping certain medications before joining. You must not use strong CYP3A4 inhibitors or inducers, systemic anticoagulants or antiplatelets (except low-dose aspirin), or hematologic support drugs shortly before enrolling. Check with the trial team about your specific medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that pacritinib is a new treatment under testing for chronic myelomonocytic leukemia (CMML). Early studies have found that patients tolerate pacritinib well. In some trials with patients who have similar conditions, pacritinib did not lead to worse outcomes compared to other treatments, suggesting it might be a good option for managing CMML symptoms.
Conversely, hydroxyurea is a more established treatment. It is generally considered safe and is often used for blood disorders. However, like any medication, it can cause side effects, such as nausea and low blood cell counts.
In summary, both pacritinib and hydroxyurea have been studied for safety, but they may affect individuals differently. Clinical trial participants will be closely monitored to ensure their safety and to address any medical issues that arise.12345Why do researchers think this study treatment might be promising for chronic myelomonocytic leukemia?
Pacritinib is unique because it targets chronic myelomonocytic leukemia (CMML) through a specific mechanism that differs from standard treatments like hydroxyurea. Unlike hydroxyurea, which is a chemotherapy drug that generally slows the growth of cancer cells, pacritinib works as a selective inhibitor of certain enzymes (JAK2/FLT3) involved in the growth of cancer cells. This targeted approach could potentially lead to more effective management of CMML with possibly fewer side effects. Researchers are excited about pacritinib because it offers a novel way to tackle the disease, providing hope for improved outcomes in patients who might not respond well to existing therapies.
What evidence suggests that this trial's treatments could be effective for chronic myelomonocytic leukemia?
This trial will compare Pacritinib with Hydroxyurea for treating chronic myelomonocytic leukemia (CMML). Research has shown that Pacritinib may help patients with myelofibrosis, particularly those with high levels of a specific white blood cell, by reducing symptoms. In studies, patients taking Pacritinib lived longer when their spleen size decreased significantly. This suggests that Pacritinib might also be useful for treating CMML by controlling the disease and easing symptoms. Currently, Hydroxyurea is used for these conditions, but Pacritinib could offer a new option that might better control the disease and relieve symptoms. However, more research is needed to confirm these benefits specifically for CMML.5678
Are You a Good Fit for This Trial?
Adults with advanced proliferative chronic myelomonocytic leukemia (CMML) can join this trial. They should have specific blood cell counts, good organ function, and an ECOG performance status of 2 or less, indicating they are able to carry out daily activities. Participants must not be pregnant and agree to use effective contraception. Those with certain levels of spleen enlargement or low platelet counts may also qualify.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either pacritinib or hydroxyurea for up to 48 weeks
Post-treatment Follow-up
Participants are monitored for safety and effectiveness after treatment
Survival Follow-up
Participants are monitored for overall survival, event-free survival, and leukemic-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Hydroxyurea
- Pacritinib
Trial Overview
The trial is testing whether pacritinib is more effective than hydroxyurea in treating CMML. Patients will be randomly assigned to take either pacritinib twice a day or hydroxyurea for up to 48 weeks, followed by a year-long observation period after treatment ends.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Pacritinib 200 mg twice daily
Hydroxyurea at doses up to 4 g daily
Find a Clinic Near You
Who Is Running the Clinical Trial?
Theradex
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
Sobi, Inc.
Industry Sponsor
MDS/MPN International Working Group (UK Sponsor)
Collaborator
Citations
MPN-499 A Retrospective Analysis of Pacritinib Treatment ...
Pacritinib is associated with a clinical benefit in myelofibrosis patients with monocytosis compared to those without, particularly in symptom reduction.
2.
clinical-lymphoma-myeloma-leukemia.com
clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(24)01441-1/abstractMPN-499 A Retrospective Analysis of Pacritinib Treatment ...
Pacritinib is associated with a clinical benefit in myelofibrosis patients with monocytosis compared to those without, particularly in symptom reduction.
3.
library.ehaweb.org
library.ehaweb.org/eha/2024/eha2024-congress/document?c_id=420119&cm_id=434952&type=document434952A RETROSPECTIVE ANALYSIS OF PACRITINIB ...
Pacritinib is associated with a clinical benefit in MF patients with monocytosis compared to those without, particularly in symptom reduction in this ...
Pacritinib Response Is Associated With Overall Survival ... - PMC
Among patients on pacritinib (n = 89), SVR ≥ 10% demonstrated the greatest separation in OS curves between responders and non‐responders (HR, 0.00; 95% CI, 0.00 ...
Study Details | NCT07033598 | Pacritinib vs. Hydroxyurea ...
This is a randomized, multicenter, open-label Phase 2 clinical trial evaluating the efficacy and safety of pacritinib compared to hydroxyurea in adult ...
Outcome of patient with high-risk chronic myelomonocytic ...
The present study describes a patient with high-risk chronic myelomonocytic leukemia (CMML), for whom decitabine therapy achieved partial remission.
Long-term treatment with pacritinib on a compassionate ...
Outcomes are particularly poor in patients with prior JAK2 inhibitor therapy: median survival in MF after discontinuing ruxolitinib is 14 months overall and ...
Pacritinib in CMML | Clinical Research Trial Listing ...
Overview. This is a phase 1/2 trial of pacritinib in combination with azacitidine in patients with Chronic Myelomonocytic Leukemia (CMML).
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