Scleroderma: Cyclophosphamide or Transplantation

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Scleroderma, SystemicSclerosisAutoimmune Disease
Interventions
BIOLOGICAL

mHSCT

Hematopoietic progenitors were mobilized with G-CSF. After leukapheresis and CD34+ cell enrichment, the autologous product was cryopreserved. Fractionated TBI (800 cGy), CY (120 mg/kg) and equine antithymocyte globulin (90 mg/kg) were administered as previously reported (References provided in citation section of this ClinicalTrials.gov record: PubMed ID: 17452515 citation and 2.) PubMed ID: 12176878 citation).

DRUG

cyclophosphamide

An initial intravenous dose of 500 mg/m\^2 was followed by 11 infusions of 750 mg/m\^2 with mesna given for bladder protection.

Trial Locations (17)

15261

University of Pittsburgh, Pittsburgh

27709

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

43606

University of Toledo Health Science Campus, Toledo

48109

University of Michigan, Ann Arbor

53226

Medical College of Wisconsin, Milwaukee

63110

Washington University School of Medicine, St Louis

77030

University of Texas-Houston Medical School, Houston

77230

MD Anderson Cancer Center, Houston

98109

Fred Hutchinson Cancer Research Center (FHCRC), Seattle

91010-3000

City of Hope National Medical Center, Duarte

90095-1670

UCLA Medical School, Los Angeles

40536-0284

University of Kentucky, Lexington

02114

Massachusetts General Hospital, Boston

02118

Boston University School of Medicine, Boston

Unknown

University of Calgary, Calgary

S7K OH6

Dr. Markland Medical Professional Corporation, Saskatoon

All Listed Sponsors
collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00114530 - Scleroderma: Cyclophosphamide or Transplantation | Biotech Hunter | Biotech Hunter