Ongoing and proposed Phase III trials of HDIT and autologous transplantation for severe autoimmune disease.*
| Disease . | Location . | Status . | Control Arm . | PBSC Mobilization / Graft . | HDIT Regimen . |
|---|---|---|---|---|---|
| *Trials listed as “proposed” are at an advanced stage of planning and are expected to open in late 2003 or early 2004. | |||||
| †A proposed randomized Phase II study in the US will compare mitoxantrone against 2 arms of HDIT with either Cy/ATG or Cy/TBI/ATG followed by autologous transplant | |||||
| Abbreviations: HDIT, high-dose immunosuppressive therapy; PBSC, peripheral blood stem cells; Ssc, systemic sclerosis; CY, cyclophosphamide; ATG, antithymocyte globulin; G-CSF, granulocyte colony-stimulating factor; SLE, systemic lupus erythematosus; RA, rheumatoid arthritis; MS, multiple sclerosis; BEAM, BCNU, etoposide, cytosine arabinoside, melphalan; TBI, total body irradiation. | |||||
| SSc | International | Open | CY 750 mg/m2 q month x 12 | CY 4 gm/m2 + G-CSF/CD34-selected graft | CY 200mg/kg + ATG |
| SSc | USA | Proposed | CY 750 mg/m2 q month x 12 | G-CSF/CD34-selected graft | TBI 8 Gy/CY 120mg/kg/ATG |
| SLE | USA | Proposed then q 3 months x 4 | CY 1000 mg/m2 q month X 6, then q 3 months x 4 | CY 4 gm/m2 + G-CSF/CD34-selected graft | CY 200mg/kg + ATG |
| RA | International | Open | Methotrexate 15–25 mg q week. or leflunomide 100mg q week and 20mg qd for 3 weeks, then 20mg qd | CY 4 gm/m2 + G-CSF/ unpurged graft | CY 200mg/kg + ATG then maintenance with methotrexate or leflunomide |
| MS † | International | Open | Mitoxantrone 20mg/month x 6 | CY 4 gm/m2 + G-CSF/unpurged graft | BEAM + ATG |
| Disease . | Location . | Status . | Control Arm . | PBSC Mobilization / Graft . | HDIT Regimen . |
|---|---|---|---|---|---|
| *Trials listed as “proposed” are at an advanced stage of planning and are expected to open in late 2003 or early 2004. | |||||
| †A proposed randomized Phase II study in the US will compare mitoxantrone against 2 arms of HDIT with either Cy/ATG or Cy/TBI/ATG followed by autologous transplant | |||||
| Abbreviations: HDIT, high-dose immunosuppressive therapy; PBSC, peripheral blood stem cells; Ssc, systemic sclerosis; CY, cyclophosphamide; ATG, antithymocyte globulin; G-CSF, granulocyte colony-stimulating factor; SLE, systemic lupus erythematosus; RA, rheumatoid arthritis; MS, multiple sclerosis; BEAM, BCNU, etoposide, cytosine arabinoside, melphalan; TBI, total body irradiation. | |||||
| SSc | International | Open | CY 750 mg/m2 q month x 12 | CY 4 gm/m2 + G-CSF/CD34-selected graft | CY 200mg/kg + ATG |
| SSc | USA | Proposed | CY 750 mg/m2 q month x 12 | G-CSF/CD34-selected graft | TBI 8 Gy/CY 120mg/kg/ATG |
| SLE | USA | Proposed then q 3 months x 4 | CY 1000 mg/m2 q month X 6, then q 3 months x 4 | CY 4 gm/m2 + G-CSF/CD34-selected graft | CY 200mg/kg + ATG |
| RA | International | Open | Methotrexate 15–25 mg q week. or leflunomide 100mg q week and 20mg qd for 3 weeks, then 20mg qd | CY 4 gm/m2 + G-CSF/ unpurged graft | CY 200mg/kg + ATG then maintenance with methotrexate or leflunomide |
| MS † | International | Open | Mitoxantrone 20mg/month x 6 | CY 4 gm/m2 + G-CSF/unpurged graft | BEAM + ATG |