Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Myelodysplastic SyndromeAplastic Anemia
Interventions
DRUG

Thymoglobulin

"3.5 or 2.5 mg/kg/day IV for 5 days~* Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~* MDS patients \<55 years receive 3.5 mg/kg/day for 5 days~* MDS patients \>55 years receive 2.5 mg/kg/day for 5 days"

DRUG

Cyclosporine

5 mg/kg orally for 6 months; start after completing thymoglobulin.

DRUG

Methylprednisolone

1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin.

DRUG

G-CSF

5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

Genzyme, a Sanofi Company

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT00806598 - Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome | Biotech Hunter | Biotech Hunter