Pegylated Interferon α-2b in Combination With Ruxolitinib for Treating Hydroxyurea-resistant/Intolerant PV

NCT05870475 | Recruiting Phase 2

• 1 other identifier: IIT2023018
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycythemia Vera

Outcome Measures

Primary Outcomes (1)

• The cumulative complete hematologic response (CHR) rate

  The proportion of patients who can achieve CHR ( defined as hematocrit lower than 45% without phlebotomies; platelet count \< 400×109/L, WBC count \< 10×109/L for at least 12 weeks) among all patients.

  From the start of study treatment (Week 0) up to the end of Week 24.

Secondary Outcomes (15)

• Cumulative CHR rates at Week 36.

  From the start of study treatment (Week 0) up to the end of Week 36.

• Cumulative CHR rates at Week 52.

  From the start of study treatment (Week 0) up to the end of Week 52.

• Time to CHR

  From the start of study treatment (Week 0) up to the end of Week 52.

• The CHR rates after crossover

  From the start of study treatment (Week 0) up to the end of Week 52.

• The rate of reduction in JAK2V617F, CALR, or MPL gene mutation burden.

  From the start of study treatment (Week 0) up to the end of Week 52.

Other Outcomes (3)

• Changes of T lymphocytes

  From the start of study treatment (Week 0) up to the end of Week 52.

• Changes of B lymphocytes

  From the start of study treatment (Week 0) up to the end of Week 52.

• Changes of dendritic cells

  From the start of study treatment (Week 0) up to the end of Week 52.

Study Arms (2)

pegylated interferon α-2b in combination with ruxolitinib group

EXPERIMENTAL

Pegylated interferon α-2b in combination with ruxolitinib group: Pegylated interferon α-2b at a starting dose of 180ug, subcutaneous injection once a week; ruxolitinib at a starting dose of 10mg, orally administered twice daily.

Drug: Ruxolitinib; Drug: Pegylated interferon α-2b

Pegylated interferon α-2b group

ACTIVE COMPARATOR

Pegylated interferon α-2b group: 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; if ruxolitinib is not tolerated, cross-over to the pegylated interferon α-2b alone group is allowed.

Drug: Pegylated interferon α-2b

Interventions

Ruxolitinib DRUG

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.

Also known as: RUX

pegylated interferon α-2b in combination with ruxolitinib group

Pegylated interferon α-2b DRUG

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.

Also known as: PEG IFNα-2b

Pegylated interferon α-2b group; pegylated interferon α-2b in combination with ruxolitinib group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Polycythemia Vera

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders

Study Officials

• Lei Zhang, MD

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

• Rongfeng Fu

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Zhang, MD

CONTACT

8602223909240; zhanglei1@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 23, 2023
• Study Start: June 30, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: July 3, 2024

Record last verified: 2024-05

Locations

CN (1)