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Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL

Peripheral T Cell Lymphoma Clinical Trial

Official title:
An Open Label, Phase II Study to Evaluate the Efficacy and Safety of Tenalisib (RP6530), Given With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) Therapy for Front Line Treatment in Patients With Peripheral T-cell Lymphoma

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05239910
Study type Interventional
Source Rhizen Pharmaceuticals SA
Contact
Status Withdrawn
Phase Phase 2
Start date January 2023
Completion date May 2027
View Details
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