Clinical Trial

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

Active, Not Recruiting Phase 2
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Summary
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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2016-02-12; most recent amendment 2026-03-26.
Status change: Recruiting → Active, Not Recruiting 2020-05-05
Status change: Active, Not Recruiting → Recruiting 2016-05-30
Status change: Not Yet Recruiting → Active, Not Recruiting 2016-05-25
Trial Details
NCT Number NCT02682641
Lead Sponsor Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Collaborators: Janssen-Cilag, S.A.
Conditions Mantle Cell Lymphoma
Enrollment 50 participants
Start Date 2016-05-18
Primary Completion 2019-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-27