Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)

PHASE2CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

January 31, 2009

Study Completion Date

June 30, 2012

Conditions
Graft vs Host DiseaseImmune System Disorders
Interventions
DRUG

Etanercept

Etanercept \[25 mg subcutaneously twice weekly for up to 4 weeks; discontinue if in complete response by 4 weeks\].

DRUG

Mycophenolate Mofetil

Mycophenolate mofetil (MMF) \[20 mg/kg (maximum 1 gm) orally or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks\].

DRUG

Denileukin Diftitox

Denileukin Diftitox (ONTAK®) \[9 mcg/kg intravenously Days 1, 3, 5, 15, 17, 19\].

DRUG

Pentostatin

Pentostatin \[1.5 mg/m2 daily for 3 days; Days 1-3 and repeat Days 15-17

Trial Locations (19)

10021

Memorial Sloan-Kettering Cancer Center, New York

19104

University of Pennsylvania Cancer Center, Philadelphia

21231

Johns Hopkins/SKCCC, Baltimore

27705

Duke University Medical Center (Peds), Durham

32610

University of Florida College of Medicine (Shands), Gainesville

44106

University Hospitals of Cleveland/Case Western, Cleveland

48109

University of Michigan Medical Center, Ann Arbor

55455

University of Minnesota, Minneapolis

63110

Washington University/Barnes Jewish Hospital, St Louis

68198

University of Nebraska Medical Center, Omaha

77030

University of Texas/MD Anderson CRC, Houston

78229

Texas Transplant Institute, San Antonio

91010

City of Hope National Medical Center, Duarte

92093

University of California, San Diego

94305

Stanford Hospital and Clinics, Stanford

97239

Oregon Health Sciences University, Portland

98109

Fred Hutchinson Cancer Research Center, Seattle

02114

DFCI/Brigham & Women's Hospital, Boston

07601

Hackensack University Medical Center, Hackensack

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

NCT00224874 - Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302) | Biotech Hunter | Biotech Hunter