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Transplantation For Scleroderma: Data from the Phase I/II Pilot Multicenter Study (FHCRC protocol 1019 )

Transplantation For Scleroderma: Data from the Phase I/II Pilot Multicenter Study (FHCRC protocol 1019 ). Equine ATG 15 mg/kg/dose §. TRANSPLANT REGIMEN*. CD34+ AUTO PBSC. CTX 60mg/kgx2. TBI 2Gy x 4 ‡ = 8 Gy. G-CSF. DAY.

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Transplantation For Scleroderma: Data from the Phase I/II Pilot Multicenter Study (FHCRC protocol 1019 )

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  1. Transplantation For Scleroderma: Data from the Phase I/II Pilot Multicenter Study (FHCRC protocol 1019)

  2. Equine ATG 15 mg/kg/dose§ TRANSPLANT REGIMEN* CD34+ AUTO PBSC CTX 60mg/kgx2 TBI 2Gy x 4‡ = 8 Gy G-CSF DAY - 5 - 4 - 3 -2 -1 0 1 3 5 • * PBSC mobilized with G-CSF at 16 ug/kg/d • ‡ TBI administered with lung shielding (lung dose= 200 cGy) for last 26 pts • § Prednisone with Equine ATG then 0.5 mg/kg/day; day 6-30, taper to day 60 McSweeney, Blood, 2002

  3. Patient Characteristics

  4. Decrease in Rodnan Skin Score after SCT GEE; p<0.0001 Mean Value Nash, Blood 2007

  5. Resolution of Dermal Fibrosis Patient 11 Skin Biopsy A+B : Pre-HCT: grade 5; low + high power C+D : 1 year post-HCT: grade 3; low + high power E+F: 5 years post-HCT: grade 0; low + high power Nash, Blood 2007

  6. HEALTH ASSESSMENT (mHAQ)

  7. Pulmonary Function after SCT for SSc GEE, p=0.002 Mean Change +2.11, p= .50 GEE, p=0.40 Mean Change -7.07, p=.02 Forced Vital Capacity DLCO (corrected for Hgb)

  8. Autologous Hematopoietic Cell Transplantation: Survival (n=34) 5 yr overall survival= 64% 5 yr PFS= 64% • Progression (from SCOT): • 1. Respiratory failure-decrease of DLCO >30% or FVC >20%. • 2. Renal failure- dialysis or kidney transplantation. • 3. Clinical heart failure or LVEF <30%.

  9. Overall Survival: SCOT-Comparable Patients and Treatment (n=22) Excluded: No lung shielding -8 Rabbit ATG -1 Eject F. (47%) -1 FVC (27%) -1 Renal failure/PHT -1 n=23 3 year OS= 87% 3 year OS= 91% 5 year OS= 78%

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