Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

September 1, 2006

Primary Completion Date

November 1, 2011

Study Completion Date

August 1, 2017

Conditions
Systemic SclerodermaSevere Systemic Sclerosis
Interventions
DRUG

fludarabine phosphate

Given IV

DRUG

Mycophenolic Acid

Given PO

DRUG

tacrolimus

Given PO

RADIATION

total-body irradiation

Undergo TBI

PROCEDURE

bone marrow transplantation

Undergo transplantation

PROCEDURE

reduced intensity allogeneic hematopoietic stem cell transplantation

Undergo transplantation

PROCEDURE

quality-of-life assessment

Ancillary studies

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

flow cytometry

Correlative studies

PROCEDURE

biopsy

Punch biopsy of skin involved with scleroderma

Trial Locations (2)

80218

Colorado Blood Cancer Institute, Denver

98109

Fred Hutch/University of Washington Cancer Consortium, Seattle

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Fred Hutchinson Cancer Center

OTHER

NCT00622895 - Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis | Biotech Hunter | Biotech Hunter