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Trial Title:
Pegylated Interferon α-2b in Combination With Ruxolitinib for Treating Hydroxyurea-resistant/Intolerant PV
NCT ID:
NCT05870475
Condition:
Polycythemia Vera
Conditions: Official terms:
Polycythemia Vera
Polycythemia
Interferons
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ruxolitinib
Description:
Ruxolitinib at a starting dose of 10mg, orally administered twice daily. If ruxolitinib
is not tolerated, cross-over to the pegylated interferon α-2b alone group is allowed.
Arm group label:
pegylated interferon α-2b in combination with ruxolitinib group
Other name:
RUX
Intervention type:
Drug
Intervention name:
Pegylated interferon α-2b
Description:
Starting dose of 180ug, subcutaneous injection once a week. If complete hematological
remission is not achieved after 12 weeks of treatment with pegylated interferon α-2b
alone, cross-over to the pegylated interferon α-2b plus ruxolitinib group is allowed.
Arm group label:
Pegylated interferon α-2b group
Arm group label:
pegylated interferon α-2b in combination with ruxolitinib group
Other name:
PEG IFNα-2b
Summary:
Study purpose: To compare the efficacy and safety of pegylated interferon α-2b in
combination with ruxolitinib versus pegylated interferon α-2b alone for treating
hydroxyurea-resistant or hydroxyurea-intolerant polycythemia vera.
Detailed description:
Study purpose: To compare the efficacy and safety of pegylated interferon α-2b in
combination with ruxolitinib versus pegylated interferon α-2b alone for treating
hydroxyurea-resistant or hydroxyurea-intolerant polycythemia vera.
The subjects will be randomly divided into two groups:
pegylated interferon alpha-2b combined with ruxolitinib group: pegylated interferon
alpha-2b at a starting dose of 180ug will be administered subcutaneously once a week;
ruxolitinib at a starting dose of 10mg will be administered orally twice daily.
pegylated interferon alpha-2b group: pegylated interferon alpha-2b at a starting dose of
180ug will be administered subcutaneously once a week.
If complete hematologic remission is not achieved after 12 weeks of treatment with
pegylated interferon alpha-2b alone, the subject may be switched to the pegylated
interferon alpha-2b combined with ruxolitinib group. If ruxolitinib is not tolerated, the
subject may be switched to the pegylated interferon alpha-2b group alone.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥18 years old.
- Male or Female.
- Meets the diagnostic criteria for Polycythemia Vera according to WHO-2022.
- Resistant or intolerant to hydroxyurea (based on the 2013 European LeukemiaNet
criteria).
- Have not previously received interferon preparations or ruxolitinib treatment, or
the washout period between the last use of interferon preparations or ruxolitinib
and the first use of the study drug should not be less than 4 weeks.
- Patients with indications for cytoreductive therapy.
- During screening, female hemoglobin (HGB) ≥10g/dL, male hemoglobin (HGB) ≥11g/dL;
neutrophil count ≥1.5×109/L; platelet count ≥100×109/L.
- Voluntary written informed consent.
Exclusion Criteria:
- Symptomatic splenomegaly;
- Contraindications to interferon or ruxolitinib therapy;
- Severe or significant comorbidities that may affect the participant's ability to
participate in the study, as determined by the investigator;
- History of major organ transplantation;
- Pregnant or breastfeeding women;
- History or current diagnosis of autoimmune thyroid disease (patients with controlled
hypothyroidism on oral thyroid hormone replacement therapy may be included);
- Documented evidence of any other autoimmune disease (such as active hepatitis,
systemic lupus erythematosus, antiphospholipid antibody syndrome, or autoimmune
arthritis);
- Clinically significant bacterial, fungal, mycobacterial, parasitic, or viral
infection such as active hepatitis or HIV infection (patients with acute bacterial
infections requiring antibiotic treatment should be deferred from
screening/enrollment until completion of antibiotic treatment);
- Evidence of severe retinopathy or clinically significant ophthalmologic disease (due
to diabetes or hypertension);
- Current clinically significant depression or history of depression, or any suicidal
attempt or tendency during screening;
- Active bleeding or thrombotic complications;
- History of any malignant tumor within the past 5 years (except for stage 0 chronic
lymphocytic leukemia [CLL], cured basal cell carcinoma, squamous cell carcinoma, and
superficial melanoma);
- History of alcohol or substance abuse within the past year;
- Presence of blasts in the peripheral blood within the past 3 months;
- Use of any investigational drug or participation in any other clinical trial within
4 weeks prior to the first dose of the study drug, or failure to recover from any
effects of previously administered study drugs;
- The investigator deems the presence of any concurrent condition that may jeopardize
the safety of the participant or the compliance to the protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Zhang, MD
Phone:
8602223909240
Email:
zhanglei1@ihcams.ac.cn
Start date:
June 30, 2023
Completion date:
May 31, 2028
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05870475
