Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2022

Primary Completion Date

March 31, 2025

Study Completion Date

December 31, 2025

Conditions
PI3Kδ InhibitorParsaclisibCHOPPTCL
Interventions
DRUG

Parsaclisib

"Phase Ib: Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. This stage follows the traditional 3+3 model. Parsaclisib is set at 10 mg/day, 15 mg/day, 20 mg/day 3 dose groups, starting from 10 mg/day, each group included 3 subjects. The final dose determined at this stage will be used in the Phase II study.~Phase II:~Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib.~Maintain treatment: 2.5mg orally every day continuously, once a day until disease progression, death or unacceptable toxicity developments. The maximum treatment time of Parsaclisib is no more than 2 years."

DRUG

CHOP

Cyclophosphamide: 750mg/m2, IV, d1 Doxorubicin: 50mg/m2, IV, d1 Vincristine: 1.4mg/m2, IV, d1 (maximum 2mg) Prednison: 100mg, po, d1-5 21 days per cycle

All Listed Sponsors
lead

Fudan University

OTHER

NCT05238064 - Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL | Biotech Hunter | Biotech Hunter