Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia

Active:	Yes
Cancer Type:	Leukemia	NCT ID:	NCT07033598
Trial Phases:	Phase II	Protocol IDs:	PROSPERA (primary) NCI-2026-00827 ABNL-MARRO 002
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Theradex
NCI Full Details:	http://clinicaltrials.gov/show/NCT07033598

Summary

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.

Objectives

This is a randomized, multicenter, open-label Phase 2 clinical trial evaluating the
efficacy and safety of pacritinib compared to hydroxyurea in adult participants with
advanced proliferative chronic myelomonocytic leukemia (CMML). Approximately 66
participants will be randomized in a 2:1 ratio to receive either pacritinib 200 mg twice
daily (n=44) or hydroxyurea (n=22) for up to 48 weeks. Randomization will be stratified
based on prior therapy (i.e., prior use of hydroxyurea or hypomethylating agents vs. no
prior therapy).

The study includes:

- A 28-day screening period

- A 48-week treatment period

- A 30-day post-treatment follow-up

- A survival follow-up phase lasting approximately one year after randomization
Participants receiving pacritinib who are not deriving benefit by Week 24, as
assessed by the treating physician, will discontinue treatment. Participants in the
hydroxyurea arm who are not deriving benefit by Week 24-or who experience
non-leukemic disease progression-may switch to pacritinib for the remainder of the
treatment period, provided they meet predefined "Safe to Switch" criteria.

Participants who discontinue study therapy due to toxicity, disease progression, or other
protocol-defined criteria will enter survival follow-up to monitor overall survival,
event-free survival, leukemic-free survival, and receipt of allogeneic hematopoietic stem
cell transplant. Data will be collected at least every three months until death,
hematopoietic stem cell transplant, or leukemic transformation.

An independent data monitoring committee will oversee safety, with the first review after
enrollment of ~18 participants and subsequent reviews approximately every 6 months.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.