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

Part of paid clinical trials in Duarte, California.

Sponsor
Pharmacyclics LLC.
Study ID
NCT02142049
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Diffuse Large B Cell Lymphoma Refractory
  • Diffuse Large B Cell Lymphoma Relapsed

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Ibrutinib
  • DA-EPOCH-R — DRUG
    Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
  • Lenalidomide — DRUG
    Lenalidomide

Study Details

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).

Key Dates

Start date
May 31, 2014
Status verified
May 2018
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017

Study Design

Enrollment
35 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Level 1
    Ibrutinib 560 mg PO + DA-EPOCH-R
  • Experimental: Part 1: Dose Level 2
    Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
  • Experimental: Part 1: Dose Level 3
    Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
  • Experimental: Part 1: Dose Level 4
    Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
  • Experimental: Part 2: RP2D
    Recommended Phase 2 Dose(RP2D): Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicities as a Measure of Safety and Tolerability [ Time Frame: 1 year after last subjects received the first dose ]

Locations (10)

FacilityCityStateZIPSite coordinators
SITE-1DuarteCalifornia91010-
SITE-2Los AngelesCalifornia90095-
SITE-10OrangeCalifornia92868-
SITE-3ChicagoIllinois60612-
SITE-5BaltimoreMaryland21201-
SITE-6BethesdaMaryland20892-
SITE-4Ann ArborMichigan48109-
SITE-8AlbuquerqueNew Mexico87106-
SITE-9Stony BrookNew York11794-
SITE-7CharlestonSouth Carolina29425-

Find similar trials in Duarte, CA

By research site
SITE-1· Duarte, CASITE-2· Los Angeles, CASITE-10· Orange, CASITE-3· Chicago, ILSITE-5· Baltimore, MDSITE-6· Bethesda, MD

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