A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV
ConditionPolycythemia Vera (PV)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuan Minghui
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years
Diagnosis of polycythemia vera (PV) according to the 2022 International Consensus Classification (ICC) criteria;
No current plan for stem cell transplantation;
Life expectancy >24 weeks;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Gecacitinib Hydrochloride Tablets；Pegylated interferon alfa-2b
DrugGecacitinib Hydrochloride Tablets: 100 mg twice daily (BID), orally, on an empty stomach. Pegylated interferon alfa-2b: 90 μg once weekly, subcutaneous injection in the abdomen or thigh.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Gecacitinib，Pegylated interferon alfa-2bExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hematologic remission rate at Week 24
Simultaneous achievement of HCT \<45%, WBC \<10×10⁹/L, and PLT ≤400×10⁹/L
Time frame
Week 24Secondary outcomes
1
HCT remission rate
Proportion of patients achieving HCT \<45% at 24 weeks
Time frame
week 242
Time to HCT remission
Time from treatment initiation to HCT remission
Time frame
Up to 24 weeks3
Duration of HCT remission
Interval from first achievement of HCT remission to reappearance of HCT ≥45%
Time frame
Through study completion, an average of 2 year4
Proportion of patients achieving spleen reduction at 24 weeks
≥10% shortening of the longest spleen diameter by palpation or normalization of spleen size
Time frame
Week 4, Week 12, Week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Duan Minghui
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Source ClinicalTrials.gov