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

PHASE2CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

August 31, 2015

Study Completion Date

February 28, 2018

Conditions
Adult T-cell Leukemia-Lymphoma
Interventions
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

Trial Locations (20)

1200

Cliniques Universitaires Saint-Luc, Brussels

10021

Memorial Sloan Kettering, New York

10032

Columbia Presbyterian, New York

10065

Weill Cornell Medical College, New York

10467

Montefiore Medical Center, The Bronx

20892

National Cancer Institute, Bethesda

33136

University of Miami / Sylvester Comprehensive Cancer Center, Miami

60611

Northwestern University, Chicago

63110

Washington University School of Medicine, St Louis

75743

Hospital Necker, Paris

90048

Cedars-Sinai Medical Center, Los Angeles

07601

Hackensack University Medical Center, Hackensack

40110-060

Hospital Universitario Professor Edgard Santos- UFBA, Salvador, Bahia

CEP 05403-000

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo- SP

BP 632 97261

CHU de Fort de France, Fort de France Cedex

Lima11

Hospital Nacional Edgardo Rebagliati Martins, Lima

Lima18

Instituto Oncologico Miraflores, Lima

SE1 9RT

Guy's Hospital, London

W2 1PG

Imperial College, London

B71 4HJ

Sandwell General Hospital, West Midlands

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Kyowa Kirin, Inc.

INDUSTRY

NCT01626664 - KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL) | Biotech Hunter | Biotech Hunter