MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas

Sponsor
International Extranodal Lymphoma Study Group (IELSG)
Study ID
NCT03697512
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Marginal Zone Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Splenic Marginal Zone Lymphoma

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    capsules for oral intake in a dosage of 560 mg (four capsules) daily
  • Rituximab — DRUG
    Concentrate solution for infusion - intravenous use; Solution for injection - subcutaneous use.

Study Details

Single-arm, phase II clinical trial of patients with Extranodal Marginal Zone Lymphoma (EMZL). It is planned to recruit 130 patients. Additional patients with Splenic Marginal Zone Lymphoma (SMZL), up to 30, and Nodal Marginal Zone Lymphoma (NMZL), up to 15, will be included in the trial in order to preliminary explore the clinical activity and safety of the combination treatment proposed. The study primary endpoints will be analysed on the EMZL population. Outcome of patients with SMZL and NMZL will be analysed and reported separately

Key Dates

Start date
Sep 27, 2019
Status verified
Apr 2026
Primary completion
Jun 15, 2027
Completion
Jun 15, 2027

Study Design

Enrollment
175 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib and Rituximab
    Induction PART A, from Day 1 to Day 56. Patients will be treated with: * Ibrutinib 560 mg/day continuously up to Day 56; * Rituximab 375 mg/m2 intravenously at Day 1, and then subcutaneous (1400 mg, flat dose) at Day 8, 15 and 22 of cycle 1. Induction PART B, from Day 57 to Day 196. Patients will be treated with: * Ibrutinib 560 mg/day continuously up to Day 196; * Rituximab subcutaneous (1400 mg, flat dose) at Day 1 every 28 days for 4 cycles. Maintenance PART C, from Day 197 to Day 730. Patients will be treated with: \- Ibrutinib 560 mg/day continuously up to Day 730.

Primary Outcome Measure

Complete Response Rate at 12 months [ Time Frame: 12 months after treatment start ]

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