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Prospective, observational study of combined PEG-IFN a -2b therapy in patients with chronic phase chronic myelogenous leukemia after poor efficacy with tyrosine kinase inhibitors

Prospective, observational study of combined PEG-IFN a -2b therapy in patients with chronic phase chronic myelogenous leukemia after poor efficacy with tyrosine kinase inhibitors

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092648
Enrollment
Unknown
Registered
2024-11-21
Start date
2023-06-20
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic myelocytic leukemia

Interventions

Peg IFN a-2b combined TKI treatment group:None

Sponsors

The West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Participants with chronic phase CML with no other concurrent tumors; 2. Participants who have not achieved MMR with TKI treatment >= 1 year or Patients who have not achieved stable DMR withTKI treatment >= 2 years; 3. Age between 18 to 70 years old; 4. ECOG score =1.5*10^9 / L and platelet (PLT)>=80*10^9 / L ; 8. Subjects voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergy to active ingredients, a -interferon or any excipients of this product; 2. Uncontrolled diabetes mellitus, hypertension, thyroid disease, retinopathy, autoimmune diseases, etc; 3. Severe liver dysfunction or decompensated liver cirrhosis; 4. A history of severe heart disease, including unstable or uncontrolled heart disease within 6 months; 5. A history of serious mental illness or serious mental illness, mainly of which are depression; 6. Pregnant women or women of childbearing potential and lactation women, or men of childbearing potential; 7. Severe kidney disease (undergoing hemodialysis), epilepsy (requiring antispasticity therapy); 8. A history of other malignancies within three years; 9. Patients with HAV, HCV, HDV, HEV infection, and autoimmune liver disease; 10. Not suitable for participating in this clinical trial judged by the investigator.

Design outcomes

Primary

MeasureTime frame
DMR%;MMR%;

Secondary

MeasureTime frame
Safety during combination therapy;Maintenance of DMR after stopping PEG-IFN a;

Countries

China

Contacts

Public ContactYunfan Yang

The West China Hospital of Sichuan University

tongjijerry@126.com+86 189 8060 7326

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026