Genotype-guided Treatment in DLBCL

Sponsor
Ruijin Hospital
Study ID
NCT05351346
Phase
PHASE3
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
  • Cyclophosphamide — DRUG
    Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
  • Doxorubicin — DRUG
    Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
  • Vincristine — DRUG
    Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
  • Prednisone — DRUG
    Prednisone PO will be administered as per the schedule specified in the respective arm.
  • Orelabrutinib — DRUG
    Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
  • Lenalidomide — DRUG
    Lenalidomide PO will be administered as per the schedule specified in the respective arm.
  • Decitabine — DRUG
    Decitabine IV infusion will be administered as per the schedule specified in the respective arm.

Study Details

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma

Key Dates

Start date
Jun 1, 2022
Status verified
Mar 2023
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
1,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: R-CHOP-X
    Patients in R-CHOP-X group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive orelabrutinib 150 mg/day PO on days 1-21, or lenalidomide 25 mg/day PO on days 2-11, or decitabine 10 mg/m² IV on days -5 to -1 followed by standard R-CHOP of every 21-day cycle.
  • Active Comparator: R-CHOP
    Patients in R-CHOP group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² iv, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for 6 cycles.

Primary Outcome Measure

Progression-free survival [ Time Frame: Baseline up to data cut-off (up to approximately 2 years) ]

Central Contacts

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