Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Part of paid clinical trials in Los Angeles, California.

Sponsor: Pharmacyclics LLC.
Study ID: NCT01325701
Phase: PHASE2
Status: Completed

Conditions

Diffuse Large Cell B-lymphoma

Eligibility Criteria

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

Interventions

ibrutinib — DRUG
ibrutinib is an inhibitor of BTK

Study Details

The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL).

Key Dates

Start date: May 31, 2011
Status verified: Mar 2017
Primary completion: Oct 31, 2014
Completion: Oct 31, 2014

Study Design

Enrollment: 78 participants (actual)
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: PCI-32765: 560 mg
Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
Experimental: PCI-32765: 840 mg
Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.

Primary Outcome Measure

Percentage of Patients With an Overall Response to Study Drug [ Time Frame: The median follow up time on the study for all treated participants is 1.7 months (range 0.1- 32.3 months) ]

Locations (15)

Facility	City	State	ZIP	Site coordinators
UCLA Medical Center	Los Angeles	California	90095	-
Stanford University School of Medicine	Stanford	California	94305	-
National Cancer Institute	Bethesda	Maryland	20892-1203	-
Mayo Clinic	Rochester	Minnesota	55905	-
University of Nebraska Medical Center	Omaha	Nebraska	68198	-
Hackensack University Medical Center	Hackensack	New Jersey	07601	-
Long Island Jewish Medical Center	New Hyde Park	New York	11042	-
Memorial Sloan-Kettering Cancer Center	New York	New York	10065	-
New York University	New York	New York	10016	-
Weill Medical College of Cornell University	New York	New York	10021	-
University of Rochester School of Medicine and Dentistry	Rochester	New York	14642	-
The Ohio Sate university	Columbus	Ohio	43210	-
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	-
Univerity of Washington	Seattle	Washington	98109	-
University of Wisconsin	Madison	Wisconsin	53705	-

Find similar trials in Los Angeles, CA

By research site

UCLA Medical Center· Los Angeles, CA Stanford University School of Medicine· Stanford, CA National Cancer Institute· Bethesda, MD Mayo Clinic· Rochester, MN University of Nebraska Medical Center· Omaha, NE Hackensack University Medical Center· Hackensack, NJ