To evaluate the efficacy and safety of Linperlisib combined with standard immunochemotherapy in patients with R/R LBCL.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Linperlisib RP2D D1-14
rituximab 375 mg/m2 D0
gemcitabine per regimen dosage
Institute of Hematology & Blood Disease Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGDose-Limiting Toxicities
Dose-Limiting Toxicities per study protocol defination
Time frame: Safety Run-in Period, up to the end of cycle 1 (each cycle is 21 days)
ORR
Response is assessed according to the Lugano criteria
Time frame: up to 2 years
Incidence of Treatment-Emergent Adverse Events
The adverse events were evaluated by NCI-CTCAE 5.0 standard Hematologic and non-hematologic toxicity
Time frame: up to 2 years
Complete Response Rate (CRR)
Response is assessed according to the Lugano criteria
Time frame: up to 2 years
Duration of Response (DOR)
From the date of achieving complete or partial response until disease progression, death or last follow-up
Time frame: up to 2 years
Duration of Complete Response (DOCR)
From the date of achieving complete response until disease progression, death or last follow-up
Time frame: up to 2 years
Progression-free Survival (PFS)
From the date of the first dose of therapy is given until disease progression, death or last follow-up
Time frame: up to 2 years
Overall Survival (OS)
From the date of the first dose of therapy is given until death, irrespective of cause
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Oxaliplatin 130 mg/m2 D1
Ifosfamide 5g/m2 D2
Carboplatin AUC=5mg/mL · min (maximum absolute dose/cycle = 800 mg)
Etoposide 100mg/m2 D1-3
Dexamethasone 40mg D1-4
Cisplatin 100mg/m2 D1, continuous intravenous infusion
Ara-C 2g/m2 q12h D2
Vinorelbine 20mg/m2 D1
Mitoxantrone hydrochloride liposome 18mg/m2 D1
Time frame: up to 2 years