Status:
UNKNOWN
Phase I/II Study of Linperlisib Plus Chidamide for R/R Cutaneous T-cell Lymphoma: a Prospective, Single-center Study
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Cutaneous T-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
HDAC inhibitor chidamide and PI3K inhibitor linperlisib has shown clinical activity as mono therapy in PTCL. The combination of duvelisib and romidepsin is highly active against relapsed and refractor...
Eligibility Criteria
Inclusion
- Ages 18-75;
- Mycosis fungoides and Sezary syndrome confirmed by histopathology;
- Patients with measurable lesions, with or without extra-cutaneous lesions, and clinical stage IIB-IVB;
- No remission or relapse after at least one systemic therapy (including total body electron irradiation, becarodine, retinoic acid, interferon, photoseparation and replacement, methotrexate, chidamide, etc.);
- ECOG score of 0-2;
- Adequate bone marrow hematopoietic function: neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥80×109/L, hemoglobin (HGB) ≥90g/L;
- Adequate organ function: NYHA grade 1-2, LVEF≥50%, ALT\<2.5UNL, TBil\<1.5ULN, SPO2 \> 93%@RA, SCr\>60ml/(min·1.73m2);
Exclusion
- Acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmia, and significantly prolonged QT interval (\> 450ms in men and \> 470ms in women) within 6 months;
- Uncontrolled active infections;
- Active hepatitis B and C infection (hepatitis B virus DNA over 1×103 copies /mL is excluded, hepatitis C virus RNA over 1×103 copies /mL is excluded)
- Pregnant or lactating women;
- Investigators judged that they were not suitable to participate in the study
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06037239
Start Date
July 1 2023
End Date
July 1 2025
Last Update
September 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730