A Phase II Study of Zanubrutinib, Lenalidomide Plus R-CHOP as the First-line Treatment for Diffused Large B-cell Lymphoma

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05200312
Phase
PHASE2
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma
  • Non Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Zanubrutinib — DRUG
    160 mg capsules administered by mouth twice daily (21-day cycles).
  • Lenalidomide — DRUG
    25 mg capsules administered by mouth once daily on Day 1 to Day 10 of each cycle (21-day cycles)
  • Rituximab — DRUG
    375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
  • Cyclophosphamide — DRUG
    750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
  • Doxorubicin — DRUG
    50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
  • Vincristine — DRUG
    1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
  • Prednisone (or equivalent) — DRUG
    40 mg/m2 capsules administered by mouth once daily on Day 1 to Day 5 of each cycle

Study Details

This study is a multi-center, open-label, single-arm, non-randomized phase II clinical study in order to evaluate the safety and efficacy of zanubrutinib, lenalidomide plus R-CHOP (ZR2-CHOP) as the first-line therapy for treatment-naive high-risk diffuse large B-cell lymphoma patients.

Key Dates

Start date
Feb 1, 2022
Status verified
Mar 2022
Primary completion
Feb 1, 2024
Completion
Feb 1, 2025

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment-naive DLBCL
    Treatment-naive high-risk DLBCL patients will be enrolled. R/R2-CHOP were allowed in cycle 1 due to poor physical condition or liver and renal failure caused by lymphoma progression. Patients achieving Complete Remission (CR) or Partial Remission (PR) after 2 cycles will receive another 2 cycles. Patients achieving CR or PR after 4 cycles will finish 6 cycles. Patients achieving CR after 6 cycles with double-hit/triple-hit/double-expression/median to high risk aaIPI will undergo Autologous Stem Cell Transplantation (ASCT). Other patients will be administered rituximab for another 2 cycles and then turn to follow-up. After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for another 3 years. Patients achieving Stable Disease (SD) or PD (Progression Disease) after 2 or 4 cycles will quit the study. After 6 cycles, patients achieving SD or PD will quit the study and patients achieving PR will receive second-line therapy.

Primary Outcome Measure

Complete response rate after six cycles of ZR2-CHOP [ Time Frame: at the end of 6 cycles(each cycle is 21 days) ]

Central Contacts

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