Clinical Trials Directory

Trials / Completed

CompletedNCT02142049

Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma

A Multicenter Study of Ibrutinib and Lenalidomide in Combination With DA-EPOCH-R in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Pharmacyclics LLC. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a Phase 1b/2, open-label, non-randomized multicenter study to assess the safety and efficacy of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL).

Detailed description

This is a Phase 1b, open-label, non-randomized multicenter study conducted in 2 parts. Part 1, will determine the MTD of the combination of ibrutinib, lenalidomide and DA-EPOCH-R in subjects with DLBCL. Ibrutinib will be administered at a fixed dose of 560 mg and lenalidomide will be dose-escalated. DA-EPOCH-R will be given at standard doses. For Part 2, the MTD determined in Part 1 will be the dose used for all subjects. If no MTD is identified, then subjects in Part 2 will be treated with the maximum administered doses (MAD, treatment doses from dose Level 4). The primary objective for Part 2 is to determine the ORR of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with ABC DLBCL as analyzed by gene expression profiling when treated at recommended phase 2 dose (RP2D).

Conditions

Interventions

TypeNameDescription
DRUGIbrutinibIbrutinib
DRUGDA-EPOCH-REtoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
DRUGLenalidomideLenalidomide

Timeline

Start date
2014-05-01
Primary completion
2017-08-01
Completion
2017-08-01
First posted
2014-05-20
Last updated
2019-02-05
Results posted
2019-02-05

Locations

10 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02142049. Inclusion in this directory is not an endorsement.