Is NCT07886801 recruiting in Middletown, NJ?

Yes, NCT07886801 is currently enrolling participants at its Middletown, NJ location. This polycythemia vera (pv) clinical trial is accepting qualified participants.

How do I join the polycythemia vera (pv) clinical trial in Middletown?

To join this clinical trial in Middletown, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Middletown clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Polycythemia Vera (PV) Clinical Trial in Middletown, NJ: Ropeginterferon

About This Polycythemia Vera (PV) Study in Middletown

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.

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion Criteria

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.

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.

Exclusion Criteria

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.

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Middletown?

Yes, this clinical trial (NCT07886801) has an active research site in Middletown, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Polycythemia Vera (PV) Treatment Options in Middletown, NJ

If you're searching for polycythemia vera (pv) treatment options in Middletown, NJ, this clinical trial (NCT07886801) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Middletown research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced polycythemia vera (pv) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all polycythemia vera (pv) clinical trials near you to find additional studies recruiting in your area.

Polycythemia Vera (PV) Clinical Trial in Middletown, NJ

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