Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

May 8, 2023

Study Completion Date

May 8, 2023

Conditions
T-cell LymphomaRelapsed and Refractory T-cell Lymphoma
Interventions
DRUG

Ibrutinib

Ibrutinib will be administered once daily continuously until disease progression (confirmed by two assessments for CTCL patients only) or intolerance. The dose levels for the Phase 1 portion of the study. Either 560 mg (4 X 140 mg capsules) or 840 mg (6 X 140 mg capsules) doses will be administered. After the recommended expansion dose is established, an expansion cohort of 12 additional patients will be treated at the recommended expansion dose to further characterize the safety at that dose and to further assess preliminary efficacy

Trial Locations (2)

10065

Memorial Sloan Kettering Cancer Center, New York

43210

Ohio State University, Columbus

All Listed Sponsors
collaborator

Ohio State University

OTHER

collaborator

Pharmacyclics LLC.

INDUSTRY

collaborator

Janssen Biotech, Inc.

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER