Linperlisib Combined With Chidamide in Patients With PTCL
ConditionPeripheral T-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYanyan Liu
About this trial
The phase Ib part of this study aims to determine the recommended phase II dose （RP2D）of linperlisib in combination with chidamide for the treatment of peripheral T-cell lymphoma (PTCL).
The phase IIa part is designed to evaluate the preliminary efficacy and safety of the linperlisib plus chidamide regimen in newly diagnosed PTCL patients.
The phase IIb part compares the efficacy and safety of linperlisib combined with chidamide versus the standard CHOP (CHOP-like) regimen in newly diagnosed PTCL patients.
Eligibility criteria
Qualifiers
Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib and IIa study)
Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large cell lymphoma, NK/T-cell lymphoma, and primary cutaneous T-cell lymphoma are not included.
ECOG PS 0-2 at protocol entry
Estimated life expectancy of 6 months or longer
Disqualifiers
Patients previously treated with PI3K inhibitor
Patients previously treated with chidamide (phase Ib study is not limited by this item)
Suspected or documented central nervous system involvement by lymphoma
Patients with positive HIV and/or active hepatitis B and/or hepatitis C infection
Trial design
Treatments tested in this trial
- Linperlisib and chidamide
- Linperlisib and chidamide
- Linperlisib and chidamide
- cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone
Treatment groups
134 Participants
are divided into 4 treatment groupsSponsors and collaborators
Yanyan Liu
Lead sponsor
Henan Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov