Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06489808
Phase
PHASE2
Status
Recruiting
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Conditions

  • Relapsed/Refractory Large B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Jul 8, 2024
Start date
May 28, 2024
Status verified
May 2024
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
89 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 transplant-ineligible patients: Linperlisib combined with R-Gemox regimen
    Cohort 1 consisted of transplant-ineligible patients who received Linperlisib in combination with R-Gemox. The treatment regimen was as follows: Linperlisib (RP2D dosage) on Days 1-14, rituximab 375 mg/m² on Day 0, gemcitabine 1000 mg/m² on Day 1, and oxaliplatin 130 mg/m² on Day 1, every 21 days for 6 cycles.
  • Experimental: Cohort 2 patients scheduled for transplantation:Linperlisib combined with R-ICE/DHAP/GVM regimens
    Cohort 2 consisted of patients scheduled for transplantation who received 3 cycles of Linperlisib (RP2D, D1-14) combined with R-ICE/DHAP/GVM regimen (R-ICE regimen: rituximab, ifosfamide, carboplatin, etoposide; R-DHAP regimen: rituximab, cytarabine, dexamethasone, cisplatin; R-GVM regimen: rituximab, gemcitabine, vinorelbine, mitoxantrone liposome), followed by autologous hematopoietic stem cell transplantation in responding patients.

Primary Outcome Measure

Dose-Limiting Toxicities [ Time Frame: Safety Run-in Period, up to the end of cycle 1 (each cycle is 21 days) ]

Central Contacts