Polycythemia Vera (PV)Phase 2NCT07886801
A Study of Ropeg-Interferon in People With Polycythemia Vera
A Phase 2 study testing Ropeginterferon in people with Polycythemia Vera (PV) and JAK2 Mutation, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The researchers are doing this study to find out whether it is practical (feasible) to stop treatment with ropeg-interferon (ropeg-INF) for some people with polycythemia vera (PV) with a change (mutation) in theJa nus kinase 2 (JAK2) gene, based on how their disease responds to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera (PV), JAK2 Mutation
- What is being tested?
- Ropeginterferon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Oct 2026to Oct 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subjects must have been diagnosed with PV per WHO 2016 or WHO 2022 criteria within 12 months of enrollment and must not have received prior cytoreductive therapy other than hydroxyurea for <6 months.54,55 Patients on hydroxyurea at the time of enrollment should discontinue hydroxyurea upon initiation of ropeg-IFN. If during the titration phase, the WBC and/or platelet counts increase to clinically significant levels, the Investigator can consider additional therapies as clinically appropriate. This transition approach has been evaluated in the ECLIPSE-PV study (NCT05481151).
- Prior treatment with aspirin and phlebotomy is permitted and should be continued per standard practice during the trial.
- Subjects with both high-risk and low-risk PV per European LeukemiaNet 2018 criteria are eligible for enrollment except for subjects with known PV-related thromboembolic complications other than DVT/PE more than 6 months prior to enrollment.
- Subjects must have a JAK2V617F allele burden of >20% at enrollment.
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- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Subject has adequate organ and hematologic function defined as:
- Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x ULN.
- Serum total bilirubin < 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis or Gilbert's syndrome.
- Serum creatinine < 2 x ULN or creatinine clearance ≥30 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR) estimation.
- White blood cell count ≥3.0 x109/L and platelet count ≥100 x10^9/L
- Females of childbearing potential may participate provided they have a negative serum pregnancy test at screening and a negative serum OR urine pregnancy test within 72 hours of starting on treatment. They also must agree to either abstain from sexual intercourse or use two forms of a highly effective method of contraception while on study.
Who cannot join
- Subjects with primary or secondary MF or pre-fibrotic MF, essential thrombocythemia, or secondary polycythemia
- Subjects with accelerated or blast-phase MPN (≥10% blasts in bone marrow or peripheral blood)
- Any systemic cytoreduction for PV in the medical history prior to study entry except for short courses (i.e., <6 months) of hydroxyurea
- Any contraindication to ropeg-IFN as defined by the FDA package insert
- Any systemic exposure to a non-pegylated or pegylated interferon-α in the medical history.
- Documented autoimmune disease at screening or in the medical history that requires treatment with systemic immunosuppressive therapy. Treatment with corticosteroids at a prednisone equivalent dose <20 mg/day at a stable dose for ≥3 months is permitted.
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- Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening.
- Infections with systemic manifestations of active disease, e.g., hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening. Patients with well-controlled disease status based on undetectable HBV, HCV, and HIV viral load are eligible for enrollment.
- Prior thromboembolic events except for DVT/PE more than 6 months prior to enrollment
- History of recurrent or current presence of depression requiring treatment with more than one antidepressant. Patients who are adequately managed on a stable dose of a single antidepressant can be considered for enrollment in discussion with the medical monitor.
- Any risk of suicide at screening based on a score of ≥1 on the Columbia-Suicide Severity Rating Scale (C-SSRS) or previous suicide attempts.
- History of severe or unstable cardiovascular disease (e.g., uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina) or recent (within the last 12 months) stroke or myocardial infarction
- Pregnancy and breast-feeding females of reproductive potential and males not using effective means of contraception. Note: women of childbearing potential not using effective contraceptive methods were not eligible for the study. A woman of childbearing potential was defined as any female having experienced menarche and who is not postmenopausal or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy).
- Evidence of severe retinopathy (e.g., cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension).
- Thyroid dysfunction (clinical symptoms of thyroid hyper- or hypofunction) not adequately controlled
- Patients tested positively to thyroglobulin (TgAb) autoantibodies and/or thyroid peroxidase (TPOAb) autoantibodies at screening.
- History of major organ transplantation.
- History of uncontrolled severe seizure disorder
- History of malignant disease, including solid tumors and hematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix or other localized, early-stage tumors that have been completely excised and are considered cured) within the last 3 years.
- Unwillingness to be transfused with blood components.
- Other conditions that, in the opinion of the investigator, may compromise the achievement of the objectives of the study
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brian Chernak, MD contact
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Raajit Rampal, MD,PhD, 646-608-3746
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Raajit Rampal, MD, PhD, 646-608-3746
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
East White Plains, New York, 10604
Raajit Rampal, MD, PhD, 646-608-3746
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Raajit Rampal, MD, PhD, 646-608-3746
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Raajit Rampal, MD, PhD, 646-608-3746
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Raajit Rampal, MD, PhD, 646-608-3746
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Raajit Rampal, MD, PhD, 646-608-3746
About this study
Official title: Efficacy of Molecularly Driven, Time-limited Treatment With Ropeg-interferon in Newly Diagnosed Patients With JAK2- Mutant Polycythemia Vera - a Multicenter, Single-arm, Phase II Study
The researchers are doing this study to find out whether it is practical (feasible) to stop treatment with ropeg-interferon (ropeg-INF) for some people with polycythemia vera (PV) with a change (mutation) in theJa nus kinase 2 (JAK2) gene, based on how their disease responds to treatment.
- Conditions
- Polycythemia Vera (PV), JAK2 Mutation
- Being tested
- Ropeginterferon
- Keywords
- Ropeg-interferon, Molecularly Driven, 26-202
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopeginterferonDrug
Patients will receive treatment with ropeg-IFN at previously established dosing subcutaneous every 2 weeks and escalated (within-person) as tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Ropeg-Interferon in People With Polycythemia Vera | Experimental | Each patient will receive ropeg-IFN subcutaneously. Receives: Drug: Ropeginterferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who meet criteria for treatment discontinuation
and sustain the same criteria without treatment re-initiation at month 48
Measured: 24 months
Secondary outcomes (1)
Proportion of patients who meet criteria for treatment discontinuation
and sustain the same criteria without treatment re-initiation at month 48
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia Vera (PV)Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multicenter, single-arm, open-label phase II study.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaEssentia
- Responsible party
- Sponsor
- Investigators
- Raajit Rampal, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886801
- Sponsor's protocol ID
- 26-202
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.