At a glance
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Phase II Study of Combination of Thymoglobulin, Cyclosporine, Methylprednisone, and Granulocyte Colony-stimulating Factor (GCSF) in Patients With Newly Diagnosed Aplastic Anemia or With Hypoplastic or Low/Intermediate-1 Risk Myelodysplastic Syndrome
In Brief
A Phase 2 clinical trial evaluating Thymoglobulin, Cyclosporine, and 2 other interventions for Myelodysplastic Syndrome and Aplastic Anemia. Completed, enrolled 53 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if combining the drugs thymoglobulin, methylprednisolone, cyclosporine, and G-CSF (NeupogenTM or NeulastaTM ) can help to control severe aplastic anemia (AA) or hypoplastic myelodysplastic syndrome (MDS). The safety of this combination therapy will also be studied.
Study Details
Timeline
Interventions
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
5 mg/kg orally for 6 months; start after completing thymoglobulin.
1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin.
5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.