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A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV | Clinical Trials | Clareo Health

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A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV

A Clinical Study of Gecacitinib Hydrochloride Tablets Combined With Pegylated Interferon as First-line Treatment in Patients With Polycythemia Vera (PV)

NCT07445893•Duan Minghui

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of Gecacitinib in combination with pegylated interferon for the treatment of polycythemia vera (PV).The main question it aims to answer is: Can PV patients achieve hematological remission after receiving the combination therapy? Participants will: Receive combination treatment with Gecacitinib Hydrochloride Tablets and pegylated interferon for 24 weeks Visit the hospital regularly for examinations and follow-up assessments

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged ≥18 years
•Diagnosis of polycythemia vera (PV) according to the 2022 International Consensus Classification (ICC) criteria;
•Presence of at least one of the following disease manifestations, defined as:
•a. Peripheral hematological abnormality: HCT ≥45% and/or PLT \>400×10⁹/L and/or WBC ≥10×10⁹/L in the absence of phlebotomy; b. Presence of weight loss \>10% over the past 6 months, night sweats, pruritus, or unexplained fever (\>37.5°C); c. Progressive splenomegaly (previous splenomegaly with an increase \>5 cm from baseline or newly developed splenomegaly); d. History of prior thrombotic or hemorrhagic events;
•No current plan for stem cell transplantation;
•Life expectancy \>24 weeks;
•ECOG performance status 0-2;
•Able to swallow tablets;
•No prior treatment with interferon or JAK inhibitors (patients who have received hydroxyurea or phlebotomy are eligible);
•No receipt of growth factors, colony-stimulating factors, thrombopoietin, or platelet transfusion within 2 weeks prior to screening, with platelet count ≥100×10⁹/L and ANC ≥1.5×10⁹/L;
+4 more criteria

Exclusion Criteria

•Any significant clinical or laboratory abnormality considered by the investigator to affect safety assessment, such as:a. Uncontrolled diabetes (\>250 mg/dL or \>13.9 mmol/L);b. Hypertension that cannot be reduced to the following range despite combination antihypertensive therapy (systolic blood pressure \<160 mmHg, diastolic blood pressure \<100 mmHg);c. Peripheral neuropathy (Grade ≥2 according to NCI-CTCAE V5.0).
•History of congestive heart failure (Grade ≥3 according to NCI-CTCAE V5.0), uncontrolled or unstable angina pectoris or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 24 weeks prior to screening.
•Patients who have undergone major surgery within 4 weeks prior to screening and have not fully recovered.
•Patients who have received PEG-IFN-α-2a or have a history of ³²P therapy within 5 weeks prior to screening.
•Patients diagnosed with primary immunodeficiency syndrome (e.g., X-linked agammaglobulinemia and common variable immunodeficiency).
•Patients with arrhythmic disorders requiring treatment at screening (except digoxin).
•Patients with any clinically symptomatic bacterial, viral, parasitic, or fungal infection requiring treatment at screening.
•Patients with active pulmonary infection indicated by chest CT examination at screening.
•Patients with a prior confirmed diagnosis of active tuberculosis infection or those with a positive interferon-gamma release assay at screening confirmed as active tuberculosis infection by the investigator.
•Patients who have undergone splenectomy or have received splenic radiation therapy within 48 weeks prior to screening.
+9 more criteria

Key Dates

Start Date

February 24, 2026

Primary Completion Date

December 30, 2026

Completion Date

December 30, 2028

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Polycythemia Vera (PV)

Interventions

Gecacitinib Hydrochloride Tablets；Pegylated interferon alfa-2b

DRUG

MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial

NCT06541249

Polycythemia Vera (PV)Essential Thrombocythemia (ET)+1 more

View study

ACTIVE_NOT_RECRUITINGPHASE2

The Ruxo-BEAT Trial in Patients With High-risk Polycythemia Vera or High-risk Essential Thrombocythemia

NCT02577926

Polycythemia Vera (PV)Essential Thrombocythemia (ET)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV

Inclusion Criteria

Exclusion Criteria

MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial

The Ruxo-BEAT Trial in Patients With High-risk Polycythemia Vera or High-risk Essential Thrombocythemia

Managed Access Programs for INC424, Ruxolitinib

Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients