The study is to investigate the safety, tolerability and efficacy of PI3Kδ inhibitor Parsaclisib in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in frontline treatment of patients with peripheral T-cell lymphoma (PTCL).
The study is to investigate the safety, tolerability and efficacy of PI3Kδ inhibitor Parsaclisib in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in frontline treatment of patients with peripheral T-cell lymphoma (PTCL) by conducting in two stages, dose-escalation stage and dose-expansion stage. In dose-escalation stage, patients with treated-naïve PTCL will be assigned to receive sequentially higher doses of parsaclisib range from 10 to 20mg po, qd plus CHOP (21 days per cycle). The dose escalation will follow the classic 3+3 design. The recommended phase 2 dose (RP2D) of parsaclisib will be determined according to the dose-escalation results. In dose-expansion stage, additional patients will be recruited to receive Par-CHOP for the planned 6 cycles or until disease progression, unacceptable drug-related adverse events or starting new anti-lymphoma treatments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
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
3-year EFS
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
Time frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Hematology and non hematology toxicity
number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Throughout the treatment period，up to 6 months
CRR
the ratio of numbers of patients with complete response to all the participants receiving treatment
Time frame: at the end of Cycle 6 (each cycle is 21 days)
ORR
the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment
Time frame: at the end of Cycle 6 (each cycle is 21 days)
EFS
the period from the date of patients sign informed consent to the observed event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment
Time frame: From date of randomization until the date of first documented event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment, whichever came first, assessed up to 3 years
OS
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Time frame: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 3 years
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