CLINICAL TRIAL SUMMARY

MDACC Study No:2004-0721 (clinicaltrials.gov NCT No: NCT00114530)
Title:A Randomized, Open-Label, Phase II Multicenter Study of High-Dose
Immunosuppressive Therapy Using Total Body Irradiation,
Cyclophosphamide, ATGAM, and Autologous Transplantation with
Auto-CD34+HPC versus Intravenous Pulse Cyclophosphamide for the
Treatment of Severe Systemic Sclerosis
Principal Investigator:Chitra M. Hosing
Treatment Agent:Antithymocyte Globulin; Cyclophosphamide; Filgrastim; Radiation
Study Status:Closed
Study Description:The goal of this clinical research study is to compare the safety and
effectiveness of high-dose immunosuppressive therapy followed by infusion of
your own peripheral blood stem cells (Stem Cell Infusion Treatment) to
cyclophosphamide (Cytoxan, CTX) alone in the treatment of SSc. The safety of
these two therapies will also be compared.

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Disease Group:Blood And Marrow Transplantation
Phase of Study:Phase II
Treatment Agents:Antithymocyte Globulin
Cyclophosphamide
Filgrastim
Radiation
Treatment Location:Independent Multicenter Arrangements
Estimated Length of Stay in Houston:Subjects will have to stay in Houston for 9-15 weeks for the transplant
procedure.
Supported By:N/A
Return Visit:Every 3 months for 1 year. Then at 24 months (2 years), 36 months (3 years), 42
months (3 1/2 years), 48 months (4 years) and 60 months (5 years) after
transplant
Home Care:Subjects may receive antibiotics, filgrastim, IV fluids via home health


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Physician Name:Chitra M. Hosing
Dept:Stem Cell Transplantation and Cellular Therapy
For Clinical Trial Enrollment:713-792-8750
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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