Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Marginal Zone Lymphoma

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT05846750
Phase
PHASE2
Status
Recruiting
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Conditions

  • Marginal Zone Lymphoma

Eligibility Criteria

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

Interventions

  • Obinutuzumab — DRUG
    Induction (6 cycles, every 28 days/cycle): 1000 mg each time, administered on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 ( 8 total infusions)； Maintenance(12 cycles, every 2 months/cycle): 12 infusions of 1000 mg every 2 months for 2 years or until disease progression
  • lenalidomide — DRUG
    Induction( 6 cycles, every 28 days/cycle): 20 mg/day, oral, Dosing on Days 2-22, every 28 days/cycle of Cycles 1-6； Maintenance(12 cycles, every 28 days/cycle):10 mg on Days 2-22 of each 28-day cycle, 12 cycles for 1 year or until disease progression

Study Details

This is a prospective, multicenter clinical study that will enroll 59 patients with relapsed and refractory (R/R) MZL. The study is designed to evaluate the efficacy and safety of the combination of obinutuzumab and lenalidomide in the treatment of relapsed and refractory marginal zone lymphoma (MZL).

Key Dates

First listed
May 6, 2023
Start date
Nov 1, 2022
Status verified
Mar 2023
Primary completion
May 31, 2026
Completion
May 31, 2028

Study Design

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

Arms

  • Experimental: Obinutuzumab and lenalidomide
    Patients will be treated with obinutuzumab and lenalidomide for 6 cycles as induction, and the patients who achieve at least a partial response after 6 cycles of induction therapy will be eligible to enter the maintenance phase for 2 years

Primary Outcome Measure

Overall Remission Rate(ORR) [ Time Frame: 24 weeks ]

Central Contacts

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