This is a phase II open label, two-arm parallel design study of T-CHOP in patients with treatment naïve PTCL. Two doses of tenalisib (400 mg BID and 800 mg BID) will be evaluated in separate groups (Group 1: 400 mg BID and Group 2: 800mg BID) when given with standard regimen of CHOP, followed by single agent maintenance treatment with tenalisib for 1 year. Recruitment of 20 patients each will be done in both groups in parallel. All eligible patients will start with a run-in period, in which single agent tenalisib will be administered for 3 cycles of 21 days each. Post run-in period, all patients will proceed to receive tenalisib and CHOP regimen for next 6 cycles. After completion of 6 cycles of T-CHOP treatment, maintenance therapy with tenalisib will be initiated in patients showing CR and PR. These patients will continue to receive single agent tenalisib for 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Tenalisib will be administered orally twice daily in a 21-day cycle for 26 cycles (from cycle 1 to cycle 26), CHOP will be administered for 6 cycles (from Cycle 4 to Cycle 9) on Days 1 to 5 of each cycle.
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Complete Response (CR) rate at the end of T-CHOP treatment.
CR rate is defined as the percentage of patients showing complete response as assessed by the Investigator according to the Lugano Classification.
Time frame: 9 months
Overall Response Rate (ORR) at the end of T-CHOP treatment.
ORR is defined as sum of CR and PR rates, as assessed by the Investigator according to the Lugano Classification
Time frame: 9 months
Duration of Response (DoR),
The duration of response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
Time frame: 3 years
Progression-Free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of documentation of progression or death from any cause
Time frame: 3 years
Overall Survival (OS)
OS is defined as the duration of time from start of treatment to death from any cause.
Time frame: 3 years
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