NCT06347653

Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL)

A Single Arm, Open Label, Multicenter Clinical Trial of Linperlisib Combined With CHOP Regimen Followed by Autologous Hematopoietic Stem Cell Transplantation and Linperlisib Monotherapy Maintenance for Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL) Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted to evaluate the efficacy and safety of linperlisib combined with CHOP regimen followed by autologous hematopoietic stem cell transplantation and linperlisib monotherapy maintenance for newly diagnosed nTFHL patients.

Conditions

• Nodal T-follicular Helper Cell Lymphoma

Interventions

Type	Name	Description
DRUG	linperlisib combined with CHOP regimen	Induction therapy: cyclophosphamide 750 mg/m2 day1, doxorubicin 40-50 mg/m2 day1, vincristine 1.4 mg/m2 (max 2 mg) day1, prednisone 100 mg day1-5, linperlisib 80mg once a day，day1-21, repeat every 21 days, for 6 cycle. Consolidation therapy: high dose chemotherapy followed by autologous hematopoietic stem cell transplantation. Maintenance therapy: linperlisib 80 mg day1-28, up to 12 cycles.

Timeline

• Start date: 2023-11-28
• Primary completion: 2027-01-31
• Completion: 2030-01-31
• First posted: 2024-04-04
• Last updated: 2024-04-04

Locations

1 site across 1 country: China