Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL

Part of paid clinical trials in Duarte, California.

Sponsor: Craig Portell, MD
Study ID: NCT02419560
Phase: PHASE1
Status: Completed

Conditions

Lymphoma, Mantle-Cell
Recurrent Lymphoma, Mantle-Cell

Eligibility Criteria

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

Interventions

ABT-199 and Ibrutinib Combination — DRUG
Both are administered orally once daily.

Study Details

The purpose of this study is to determine the optimal dosing scheme for the combination of ibrutinib with ABT-199 for the treatment of relapsed or refractory mantle cell lymphoma (MCL).

Key Dates

Start date: Apr 30, 2015
Status verified: May 2022
Primary completion: May 31, 2021
Completion: May 31, 2021

Study Design

Enrollment: 37 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: ABT-199 and Ibrutinib Combination
Participants will take ABT-199 (dose 100-400 mg) and Ibrutinib (dose 280-560 mg).

Primary Outcome Measure

Incidence of Dose Limiting Toxicities [ Time Frame: 30 Days Following Start of Treatment ]

Locations (4)

Facility	City	State	ZIP	Site coordinators
City of Hope	Duarte	California	91010	-
Winship Cancer Institute, Emory University	Atlanta	Georgia	30322	-
Washington University School of Medicine	St Louis	Missouri	63110	-
University of Virginia	Charlottesville	Virginia	22908	-

Find similar trials in Duarte, CA

By research site

City of Hope· Duarte, CA Winship Cancer Institute, Emory University· Atlanta, GA Washington University School of Medicine· St Louis, MO University of Virginia· Charlottesville, VA