A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms

PHASE1CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

February 28, 2017

Conditions
Lymphoma, Large-Cell, AnaplasticLymphoma, NK-cellLymphoma, T-cell
Interventions
DRUG

brentuximab vedotin

1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)

DRUG

cyclophosphamide

750 mg/m2 IV every 3 weeks (Cycles 3-8)

DRUG

brentuximab vedotin

1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)

DRUG

prednisone

100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)

DRUG

cyclophosphamide

750 mg/m2 IV every 3 weeks (Cycles 1-6)

DRUG

doxorubicin

50 mg/m2 IV every 3 weeks (Cycles 3-8)

DRUG

doxorubicin

50 mg/m2 IV every 3 weeks (Cycles 1-6)

DRUG

prednisone

100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)

DRUG

vincristine

1.4 mg/m2 IV every 3 weeks (Cycles 3-8)

Trial Locations (11)

10021

Memorial Sloan Kettering Cancer Center, New York

19111

Fox Chase Cancer Center, Philadelphia

29601

St. Francis Hospital, Greenville

63110

Washington University School of Medicine, St Louis

91010

City of Hope National Medical Center, Duarte

94305

Stanford Cancer Center, Stanford

98109

Seattle Cancer Care Alliance / University of Washington Medical Center, Seattle

35294-3300

UAB Comprehensive Cancer Center, Birmingham

77030-4000

MD Anderson Cancer Center / University of Texas, Houston

M20 4BX

Christie Hospital NHS Foundation Trust, Manchester

SO16 6YD

Southampton General Hospital, Southampton

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

Seagen Inc.

INDUSTRY

NCT01309789 - A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms | Biotech Hunter | Biotech Hunter