Safety Study to Evaluate Monoclonal Antibody KW-0761 in Subjects With Peripheral T-cell Lymphoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Peripheral T-Cell Lymphoma
Interventions
BIOLOGICAL

KW-0761

The starting dose will be 0.1 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. Succeeding dose levels will include 0.3 and 1 mg/kg. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met.

Trial Locations (5)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

77030

M.D.Anderson Cancer Center, Houston

90095

Ronald Reagan UCLA Medical Center, Los Angeles

94305

Stanford Medical Center, Stanford

06519

Yale Comprehensive Cancer Center, New Haven

Sponsors
All Listed Sponsors
collaborator

Kyowa Hakko Kirin Pharma, Inc.

INDUSTRY

lead

Kyowa Kirin Co., Ltd.

INDUSTRY