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

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