Status:
UNKNOWN
Phase I/II Study of Linperlisib Plus Chidamide for R/R Peripheral T-cell Lymphoma: a Prospective, Multi-center Study
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Peripheral 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 for relapsed and refractory PT...
Eligibility Criteria
Inclusion
- Ages 18-75;
- Pathologically confirmed diagnosis of PTCL, not otherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), angioimmunoblastic T-cell lymphoma (AITL), or other PTCL subtypes that the researchers considered to be eligible;
- Fulfills the criteria for relapsed/refractory lymphoma;
- There must be at least one measurable lesion: for measurable lymph node, the longest diameter should be \> 1.5cm, for measurable extranodal lesion, the longest diameter should be \> 1.0cm;
- 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\<3UNL, TBil\<2ULN, SPO2 \> 93%@RA, SCr\>60ml/(min·1.73m2);
Exclusion
- Extranodal natural killer/T cell lymphoma;
- Previously treated with PI3K inhibitors;
- 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;
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 25 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06083701
Start Date
September 25 2023
End Date
September 25 2025
Last Update
October 16 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital
Beijing, Beijing/China, China, 100000
2
Beijing Hospital
Beijing, China