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Not yet recruitingPhase 2

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

Ropeginterferon Alfa-2b for MDS/MPN Overlap Syndromes, Including CMML and MDS/MPN-RS-T

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 months
  • Procedures mentioned: CT scans, Blood draws, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To assess the percentage of splenomegaly changes on clinical exam and on computed tomography (CT)."
  • "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."
  • "After completion of study treatment, patients are followed up at 28 days and then every 3 months for up to 24 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety, best dose, and effects of ropeginterferon alfa-2b in adults with certain blood cancers called MDS/MPN overlap syndromes, including chronic myelomonocytic leukemia (CMML). This long-acting drug is a form of an immune system protein that may slow cancer cell growth.

This phase II trial tests the safety, best dose, and effectiveness of ropeginterferon alfa-2b for the treatment of patients with myelodysplastic syndrome/myeloproliferative neoplasm overlap syndromes and chronic myelomonocytic leukemia. Ropeginterferon alfa-2b is a form of interferon. Interferons are a type of signaling protein normally produced by the body as part of the immune response. Interferons interfere with the division of cancer cells and can slow cancer cell growth. Ropeginterferon alfa-2b is a long-acting form of a type of interferon called interferon alfa-2b. In the body, ropeginterferon alfa-2b causes the production of proteins that modulate the immune system and have anticancer effects.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have a confirmed MDS/MPN overlap syndrome, including CMML, that the study doctor thinks may benefit from this study.
  • You or your legal representative must give written consent, and you must be able to follow study requirements.
  • Have no more than 10% blasts, or immature blood cells, in a bone marrow test.
  • Have platelets, which help blood clot, above 50,000/uL and neutrophils, which fight infection, above 1,000/uL.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Have a creatinine level, a kidney test, of 2.5 mg/dL or less.
  • Meet liver test limits: direct bilirubin below 2.0 mg/dL and liver enzymes below 2.5 times the upper normal limit, or below 5 times that limit if the rise is linked to MDS/MPN.

Who can't join

  • Past treatment with interferon, pegylated interferon, or azacitidine; or other MDS/MPN treatment within 28 days before study treatment. Hydroxyurea may continue through the first 28 days of study treatment.
  • A clearly enlarged spleen on a physical exam, a past organ transplant, or pregnancy or breastfeeding.
  • A serious autoimmune disease, where the immune system attacks the body, or a severe or important eye disorder.
  • Past or current depression or anxiety that the study doctor considers important, or any past suicidal thoughts or attempts.
  • An active, uncontrolled infection with symptoms, or uncontrolled blood clots or bleeding.
  • Cancer within the past 5 years. Exceptions include certain treated skin, prostate, cervical, breast, or early uterine cancers, and other cured cancers with no signs of disease for at least 1 year.
  • Another serious, uncontrolled illness that the study doctor thinks could affect participation.
  • Current abuse of alcohol or illegal drugs.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Study sites (1)

CA