NCT01626664

KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).

Detailed description

CCR4 expression in ATL patients has been demonstrated to be very high and has been associated with shorter survival compared with CCR4-negative patients. KW-0761, a monoclonal antibody targeted to CCR4, has been shown to be safe and tolerable in several clinical trials in subjects with a variety of T-cell malignancies, including ATL, mycosis fungoides and Sézary syndrome. The objective of this study is to estimate the overall response rate of KW-0761 for subjects with relapsed or refractory ATL.

Conditions

• Adult T-cell Leukemia-Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	KW-0761	1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
DRUG	Pralatrexate	30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression
DRUG	gemcitabine plus oxaliplatin	gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression
DRUG	DHAP	dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-08-01
• Completion: 2018-02-01
• First posted: 2012-06-25
• Last updated: 2024-04-25
• Results posted: 2018-06-15

Locations

20 sites across 6 countries: United States, Belgium, Brazil, France, Peru, United Kingdom