Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients

Sponsor
International Extranodal Lymphoma Study Group (IELSG)
Study ID
NCT05735834
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Splenic Marginal Zone Lymphoma

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    Truxima concentrate for solution for infusion 500 mg/50 ml
  • Zanubrutinib — DRUG
    Zanubrutinib 80 mg hard capsules

Study Details

The goal of this clinical trial is to compare the efficacy and tolerability of the combination of two medicinal products, rituximab, and zanubrutinib, compared to rituximab monotherapy in patients with Splenic Marginal Zone Lymphoma (SMZL), previously untreated and who need systemic treatment. The main questions it aims to answer are: * Is the combination rituximab and zanubrutinib a more effective therapy than rituximab monotherapy? * Is the combination therapy, rituximab and zanubrutinib, well tolerated? Study participants will be put into one of the two treatment groups (rituximab and zanubrutinib or rituximab alone) for a maximum of two years and will undergo regular visits until three years from treatment start.

Key Dates

Start date
May 21, 2024
Status verified
Mar 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
122 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - Rituximab + Zanubrutinib
    Zanubrutinib (160 mg BID orally continuous dosing) is administered for 12 cycles of 28 days each. After cycle 12: 1. Patients in Complete Response (CR) will stop treatment and enter the follow-up phase. 2. Patients in partial response (PR) will continue zanubrutinib treatment (160 mg BID orally continuous dosing) for 12 additional cycles of 28 days each for a total of 24 cycles. 3. Patients in stable disease (SD) or progressive disease (PD) will stop treatment and will enter the follow-up phase. Rituximab is infused at the dose of 375 mg/m2 iv on days 1, 8, 15, and 22 of cycle 1 (28 days per cycle), then on day 1 of cycles 3, 6, 9, and 12 (28 days per cycle). After cycle 12: 1. Patients in CR will stop treatment and enter the follow-up phase. 2. Patients in PR will go on with rituximab 375 mg/m2 IV on day 1 of cycles 15, 18, 21, and 24 (28 days per cycle). 3. Patients in SD or PD will discontinue treatment and will enter the follow-up phase.
  • Active Comparator: Arm B - Rituximab
    Rituximab is infused at the dose of 375 mg/m2 iv on days 1, 8, 15, and 22 of cycle 1 (28 days per cycle), then on day 1 of cycles 3, 6, 9, and 12 (28 days per cycle). After cycle 12: 1. Patients in CR will stop treatment and enter the follow-up phase. 2. Patients in PR will go on with rituximab 375 mg/m2 iv on day 1 of cycles 15, 18, 21, and 24 (28 days per cycle). 3. Patients in SD or PD will discontinue treatment and will enter the follow-up phase

Primary Outcome Measure

Progression Free Survival (PFS) rate at 3 years [ Time Frame: From the date of randomization to the date of progression or the date of death from any cause until 3 years after randomization ]

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