Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of MCL

Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Study ID
NCT02682641
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • IBRUTINIB — DRUG
    Ibrutinib 560 mg daily po for 28 days (cycle one). Continuous cycles until disease progression or unacceptable toxicity.
  • Rituximab — DRUG
    Rituximab 375 mg/m2 iv day 1,8, 15 and 22 (cycle 1, 4 doses). Rituximab 375 mg/m2 iv, day one of every other cycle for 4 doses (cycle 3, 5, 7 and 9).

Study Details

Phase II study with a two-stage design to evaluate efficacy and safety of ibrutinib in combination with rituximab (I+R) in untreated patients with indolent clinical forms of MCL. An extensive biological study will be conducted in order to further characterize this population of MCL patients and evaluate the response obtained with the mutational profile of the tumor.

Key Dates

Start date
May 18, 2016
Status verified
Mar 2026
Primary completion
Dec 31, 2019
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: IBRUTINIB + RITUXIMAB
    Subjects will receive the ibrutinib in combination with rituximab according to the following schedule: * Ibrutinib 560 mg daily po until disease progression or unacceptable toxicity. In case of sustained negative MRD (at least for 6 months) after 2 years of continuous therapy, ibrutinib will be discontinued. * Rituximab 375 mg/m2 iv day 1,8, 15 and 22 (cycle 1). Rituximab 375 mg/m2 iv, day one of every cycle 3, 5, 7 and 9.

Primary Outcome Measure

Rate of complete remission [ Time Frame: 12 months ]

Related Studies