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Ropeginterferon Alfa-2b for Myelodysplastic/Myeloproliferative Neoplasm Overlap Syndromes

This study is testing a medication called ropeginterferon alfa-2b for people with myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap syndromes, including chronic myelomonocytic leukemia (CMML). Ropeginterferon alfa-2b is a type of interferon, which are proteins your body naturally makes to fight off illnesses. This medication works by slowing down the growth of cancer cells and boosting your immune system. The main goals are to see how safe and effective ropeginterferon alfa-2b is, and how many people respond to the treatment. You may be able to join if you are 18 or older and have a confirmed diagnosis of one of these MDS/MPN overlap syndromes. The study aims to enroll 35 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 35 participants. The phase of the study is not specified.
What's involved
Participants will undergo blood sample collection, bone marrow aspiration and biopsy, CT scans, and complete questionnaires. The duration of these commitments is not specified.
Compensation
Not stated in the trial record.
Follow-up
The study will measure overall response and adverse events for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07468916

Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Jonsson Comprehensive Cancer Center
~35 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow AspirationBone Marrow BiopsyComputed TomographyQuestionnaire AdministrationRopeginterferon Alfa-2B

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response
Measured over Up to 24 months
+1 more outcome measured

Conditions

Atypical Chronic Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Myelodysplastic/Myeloproliferative Neoplasm
Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified
Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified

Explore related trials

Atypical Chronic Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic/Myeloproliferative Neoplasm, Not Otherwise SpecifiedMyelodysplastic/Myeloproliferative Neoplasm with Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified

NCT07468916

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, Californiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Wanxing Chai-Ho, MD · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Vladimir Kustanovich
[email protected]
310-206-5756
Email the study team

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Eligibility criteria

Inclusion

Male or female ≥ 18 years of age at time of consent
Documentation of a diagnosis of MDS/MPN overlap syndrome based on World Health Organization (WHO) 2022 classification, including CMML, MDS/MPN with neutrophilia, myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T), or MDS/MPN, not otherwise specified, by local pathology review, and deemed to potentially benefit from study participation by the investigator
Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
Blast =\< 10% by marrow immunohistochemistry stain
Platelet count of \> 50,000/uL
Absolute neutrophils count (ANC) of \> 1000/uL
Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
Serum creatinine =\< 2.5 mg/dL
Serum direct bilirubin \< 2.0 mg/dL
Serum transaminase \< 2.5 times the upper limit of the normal range (ULN) or \< 5 times ULN if the transaminase elevation was deemed related to the MDS/MPN

Exclusion

Prior therapy with interferon or pegylated interferon product, or azacitidine
Spleen overtly enlarged by physical exam (eg. greater than 5 fingerbreadth below costal margin)
Other standard (including erythropoietin-stimulating agents \[ESA\] or luspatercept) or experimental therapy for MDS/MPN within 28 days of starting study therapy with the exception of hydroxyurea, which is allowed to continue up to 28 days after cycle 1 day 1 (C1D1) while on protocol
Clinically significant autoimmune disease by investigator assessment, regardless if the autoimmune phenomena is related to MDS/MPN overlap syndrome
History of or current clinically relevant depression or anxiety per investigator's judgement. Previous suicidal ideation or attempts are not allowed to participate in interferon (IFN) therapy
Evidence of severe retinopathy or clinically relevant ophthalmological disorder
History of organ transplant
Pregnant or breastfeeding women
Active uncontrolled infection with clinical symptoms, e.g., presence of bacteria, fungal, human immunodeficiency virus (HIV), hepatitis B or C
Active uncontrolled thromboembolic complications or hemorrhage
History of any malignancy within 5 years (except adequately treated non-melanoma skin cancer, prostate cancer status post resection with an undetectable prostate-specific antigen \[PSA\], curative treated in-situ cancer of the cervix, ductal carcinoma in situ \[DCIS\] of the breast, stage 1 grade 1 endometrial carcinoma, or other solid tumors including lymphomas curatively treated with no evidence of disease for ≥ 1 year prior to study)
Uncontrolled active clinically significant illness that, in the investigator's opinion, may affect the patient's participation in this study
Active abuse of alcohol and/or illicit drugs

What this trial measures

  • Overall responseUp to 24 months

    Will be assessed per the 2015 international consortium proposal (ICP) myelodysplastic syndrome (MDS)/myeloproliferative neoplasm (MPN) criteria. Overall response rate is defined as the best objective 2015 ICP MDS/MPN response achieved at any time on study (complete remission, complete cytogenetic remission, partial remission, marrow response or clinical benefit). Will be summarized as proportions with corresponding 95% exact binomial confidence intervals.

  • Incidence of adverse eventsUp to 24 months

    The incidence of adverse events, both hematological and non-hematological will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will be summarized as proportions with corresponding 95% exact binomial confidence intervals.