At a glance
ClinicalIndex Comparison RecordPhase 1Active· 27 enrolled
Drug / intervention
Lenalidomide +2 moredrug
Likely dose
Lenalidomide 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase Ib Dose Finding Study of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma (MCL)
In Brief
A Phase 1 clinical trial evaluating Lenalidomide, Ibrutinib, and 1 other intervention for Mantle Cell Lymphoma. Active but no longer recruiting, targeting 27 participants across 1 site.
Detailed Summary
This is a dose-escalation to determine the MTD and/or RPII for combinations of ibrutinib (PCI-32765) plus lenalidomide/rituximab in patients with relapsed/refractory mantle cell lymphoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMantle Cell Lymphoma
CountriesUnited States
Collaborators--
Timeline
Phase 1ActiveOverdue
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartJun 2015
Primary CompletionJan 2017
Study CompletionJul 2026
TodayJul 2026
First PostedMay 18, 2015
Enrollment StartJun 18, 2015
Primary CompletionJan 3, 2017
Study CompletionJul 1, 2026
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.1 years ago
Interventions
Lenalidomidedrug
Dose escalation of lenalidomide. Patients will receive 10, 15, 20, or 25 mg PO days 1-21
Ibrutinibdrug
560 mg PO daily
Rituximabdrug
375 mg/m2 IV Day 1