Ropeginterferon Alfa-2b for Chronic Myelomonocytic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ropeginterferon alfa-2b for individuals with certain blood disorders, including chronic myelomonocytic leukemia (CMML). Ropeginterferon alfa-2b is a long-acting protein that boosts the immune system to combat cancer cells. The trial aims to determine the optimal dose and assess the treatment's safety and effectiveness. Individuals diagnosed with myelodysplastic/myeloproliferative overlap syndromes, who have not previously received similar medications, might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop all current medications, but you cannot have had other standard or experimental therapies for MDS/MPN within 28 days of starting the study, except for hydroxyurea, which you can continue for up to 28 days after starting the trial.
Is there any evidence suggesting that ropeginterferon alfa-2b is likely to be safe for humans?
Research has shown that ropeginterferon alfa-2b is generally safe. Earlier studies reported no very serious side effects. Some patients experienced moderate side effects, but these were uncommon. People with chronic myelomonocytic leukemia usually tolerate the treatment well. Ropeginterferon alfa-2b is also approved for treating polycythemia vera, another blood condition, indicating it has undergone human safety testing. This approval provides some confidence in its safety for trial participants.12345
Why do researchers think this study treatment might be promising?
Ropeginterferon Alfa-2b is unique because it targets chronic myelomonocytic leukemia (CMML) with a novel mechanism of action using a pegylated interferon. Unlike traditional treatments for CMML, such as hydroxyurea or hypomethylating agents like azacitidine, which focus on reducing leukemic cell proliferation, Ropeginterferon Alfa-2b works by modulating the immune system to fight cancer cells more effectively. Additionally, its administration via subcutaneous injection every two weeks offers a potentially more convenient and manageable treatment schedule. Researchers are excited about its potential to provide a new, effective option with a different approach to managing CMML.
What evidence suggests that ropeginterferon alfa-2b might be an effective treatment for chronic myelomonocytic leukemia?
Research has shown that ropeginterferon alfa-2b can be effective for certain blood cancers. In one study on polycythemia vera, a type of blood cancer, it achieved an important goal in 81% of patients after 12 months, compared to 51% with standard treatment. Ropeginterferon alfa-2b has also managed other blood disorders by controlling blood cell levels and reducing the need for additional treatments. This treatment boosts the immune system and slows cancer cell growth. While these results are promising, more research is needed to fully understand its potential for chronic myelomonocytic leukemia. Participants in this trial will receive ropeginterferon alfa-2b to evaluate its effectiveness specifically for chronic myelomonocytic leukemia.13456
Who Is on the Research Team?
Wanxing Chai-Ho, MD
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with certain blood cancers called myelodysplastic/myeloproliferative neoplasm overlap syndromes or chronic myelomonocytic leukemia. Participants need to have stable organ function, not be pregnant or breastfeeding, and cannot have had prior interferon treatment, recent cancer therapies, severe depression, active infections, or other serious illnesses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ropeginterferon alfa-2b subcutaneously on days 1 and 15 of each 28-day cycle, repeating for up to 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Ropeginterferon Alfa-2B
Trial Overview
The study is testing the safety and effectiveness of ropeginterferon alfa-2b—a long-acting immune system protein—given to people with specific blood cancers. The trial includes regular medical tests like bone marrow biopsies and scans to monitor response.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive ropeginterferon alfa-2b SC on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 24 months (26 cycles) in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy, CT, and collection of blood samples throughout the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
PharmaEssentia
Industry Sponsor
Citations
Randomized phase 3 trial of Ropeginterferon alfa-2b ...
The Kaplan-Meier probabilities MRFS by 6, 12, and 24 months after TKI discontinuation were 73% (95%-CI, 62–81%), 64% (53–73%) and 56% (45–66%) ...
Study Details | NCT07468916 | Ropeginterferon Alfa-2b for ...
This phase II trial tests the safety, best dose, and effectiveness of ropeginterferon alfa-2b for the treatment of patients with myelodysplastic ...
Efficacy and safety of ropeginterferon alfa-2b in the treatment ...
In the LOW-PV trial, ropeginterferon alfa-2b achieved the composite endpoint in 81% of patients at 12 months versus 51% with phlebotomy alone, ...
4.
clinical-lymphoma-myeloma-leukemia.com
clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(25)00216-2/abstractReal-World Evidence on Outcomes and Safety of ...
RopegIFN demonstrated hematological and molecular efficacy across Ph- MPN subtypes and was generally well tolerated. However, its effectiveness appears limited ...
5.
targetedonc.com
targetedonc.com/view/endure-no-added-benefit-with-ropeginterferon-alfa-2b-after-tki-stoppage-in-cmlENDURE: No Added Benefit With Ropeginterferon Alfa-2b ...
Ropeginterferon alfa-2b showed no significant MRFS benefit over observation in CML patients post-TKI cessation. High rates of MMR regain were ...
6.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/2039/551131/Long-term-efficacy-and-safety-of-ropeginterferonLong-term efficacy and safety of ropeginterferon alfa-2b under ...
Furthermore, ropeg demonstrated a favorable safety profile, with no Grade 4 or higher adverse events (AEs) observed and grade 3 AEs occurring in ...
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