Ibrutinib Combined With Rituximab for Treatment of Relapsed Refractory MYD88 and CD79A/B (or CD79B Alone) DLBCL Who Have Received at Least Two Prior Therapies

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT04994626
Phase
PHASE2
Status
Unknown

Conditions

  • CD79A Gene Mutation
  • CD79B Gene Mutation
  • DLBCL
  • MYD88 Gene Mutation
  • Refractory Lymphoma
  • Relapse

Eligibility Criteria

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

Interventions

  • Ibrutinib Combined With Rituximab — DRUG
    Drug: ibrutinib ibrutinib 560mg administered orally once daily. Other Name: Imbruvica Drug: rituximab rituximab 375mg/m² administered intravenously (IV)

Study Details

The purpose of this study is to evaluate the efficacy and safety of Ibrutinib Combined With Rituximab in Relapsed Refractory MYD88 and CD79A/B (or CD79B Alone) DLBCL Who Have Received at Least Two Prior Therapies.

Key Dates

Start date
Oct 1, 2021
Status verified
Aug 2021
Primary completion
Apr 1, 2022
Completion
Jul 1, 2025

Study Design

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

Arms

  • Experimental: Ibrutinib Combined With Rituximab
    Induction therapy: Ibrutinib 560mg administered oral once a day of each 21-day cycle for 6 cycles. Rituximab 375mg/m² administered intravenously (IV) on Day 1 of each 21-day cycle for 6 cycles. Maintenance therapy: Ibrutinib 560mg administered oral once a day of each 56-day cycle for 6 cycles. Rituximab 375mg/m² administered intravenously (IV) on Day 1 of each 56-day cycle for 6 cycles.

Primary Outcome Measure

Objective Response Rate(ORR) [ Time Frame: 24 months after the last patient's enrollment ]

Central Contacts

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