Trial of PCI-32765 (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02269085
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Phase I Starting Dose: 420 mg by mouth daily on Days 1 - 28 of a 28-day cycle. Phase II Starting Dose: MTD from Phase I.
  • Carfilzomib — DRUG
    Phase I Starting Dose: 20 mg/m2 by vein on Days 1, 2, 8 ,9, 15 and 16 in Cycles 1 - 12, and Days 1,2 and 15,16 of Cycle 13 and beyond. Phase II Starting Dose: MTD from Phase I.
  • Phone Calls — BEHAVIORAL
    Study staff calls participant after end-of-dosing visit every 6 months for 5 years. These calls should take about 2-3 minutes.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of carfilzomib and ibrutinib that can be given to patients with relapsed or refractory MCL. Researchers also want to learn if carfilzomib and ibrutinib can help to control the disease. This is an investigational study. Ibrutinib is FDA approved and commercially available to treat MCL and chronic lymphocytic leukemia (CLL). Carfilzomib is FDA approved and commercially available to treat certain types of multiple myeloma. Giving carfilzomib to patients with MCL is investigational. The combination of ibrutinib and carfilzomib is investigational. The study doctor can explain how the study drugs are designed to work. Up to 35 participants will be enrolled on this study. All will be enrolled at MD Anderson.

Key Dates

Start date
Apr 20, 2015
Status verified
Feb 2019
Primary completion
May 29, 2018
Completion
May 29, 2018

Study Design

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

Arms

  • Experimental: Ibrutinib + Carfilzomib
    Phase I: Ibrutinib administered by mouth daily at 420 or 560 mg on Days 1 - 28 of a 28-day cycle. Carfilzomib administered by vein 20/27 mg/m\^2, 20/36 mg/m\^2, 20/45 mg/m\^2 or 20/56 mg/m\^2 on days 1, 2, 8, 9, 15 and 16 of a 28-day cycle for Cycles 1- 12 and on Days 1, 2, 15 and 16 for Cycle 13 and higher. Phase II: Once the MTD has been established 5 additional patients treated at the MTD to a maximum of 35 patients with MCL. Study staff calls participant after end-of-dosing visit every 6 months for 5 years.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Carfilzomib When Given With Ibrutinib [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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