NCT06489808

Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL

An Open-label, Multicenter, Multi-cohort Clinical Study of Linperlisib Combined With Standard Immunochemotherapy in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma Failing to First-line Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Linperlisib combined with standard immunochemotherapy in patients with R/R LBCL.

Detailed description

This is a phase 2, open-label, multicenter, multi-cohort study evaluating the efficacy and safety of Linperlisib combined with standard immunochemotherapy in the treatment of relapsed/refractory LBCL after first-line treatment. This study is divided into a safety run-in phase and a dose expansion phase.The primary objective of the safety run-in phase was to determine the recommended dose for the dose expansion phase based on dose-limiting toxicities (DLTs). The dose expansion phase consisted of Cohort 1 and Cohort 2.Cohort 1 was transplant-ineligible patients who received Linperlisib in combination with R-Gemox at RP2D for 6 cycles.Cohort 2 consisted of patients scheduled for transplantation who received 3 cycles of Linperlisib combined with R-ICE/DHAP/GVM regimen, followed by autologous hematopoietic stem cell transplantation in responding patients

Conditions

• Relapsed/Refractory Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Linperlisib	Linperlisib RP2D D1-14
DRUG	Rituximab	rituximab 375 mg/m2 D0
DRUG	Gemcitabine	gemcitabine per regimen dosage
DRUG	Oxaliplatin	Oxaliplatin 130 mg/m2 D1
DRUG	Ifosfamide	Ifosfamide 5g/m2 D2
DRUG	Carboplatin	Carboplatin AUC=5mg/mL · min (maximum absolute dose/cycle = 800 mg)
DRUG	Etoposide	Etoposide 100mg/m2 D1-3
DRUG	Dexamethasone	Dexamethasone 40mg D1-4
DRUG	Cisplatin	Cisplatin 100mg/m2 D1, continuous intravenous infusion
DRUG	Ara-C	Ara-C 2g/m2 q12h D2
DRUG	Vinorelbine	Vinorelbine 20mg/m2 D1
DRUG	Mitoxantrone hydrochloride liposome	Mitoxantrone hydrochloride liposome 18mg/m2 D1

Timeline

• Start date: 2024-05-28
• Primary completion: 2026-12-31
• Completion: 2027-05-31
• First posted: 2024-07-08
• Last updated: 2024-07-08

Locations

1 site across 1 country: China