Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00806598|
Recruitment Status : Completed
First Posted : December 11, 2008
Results First Posted : March 6, 2013
Last Update Posted : March 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome Aplastic Anemia||Drug: Thymoglobulin Drug: Cyclosporine Drug: Methylprednisolone Drug: G-CSF||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: Thymoglobulin + Cyclosporin
Combination of Thymoglobulin 3.5 or 2.5 mg/kg/day intravenous (IV) for 5 days + Methylprednisone 1 mg/kg/day IV for 5 days, before each dose Thymoglobulin + Cyclosporin 5 mg/kg orally for 6 months following Thymoglobulin + Granulocyte - Colony Stimulating Factor (G-CSF) 5 microgram/kg subcutaneously daily up to 3 months
3.5 or 2.5 mg/kg/day IV for 5 days
Other Names:Drug: Cyclosporine
5 mg/kg orally for 6 months; start after completing thymoglobulin.
Other Names:Drug: Methylprednisolone
1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin.
Other Names:Drug: G-CSF
5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.
- Overall Response [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed first at 3 months on study, continuing monthly up to 3 years. ]Complete response (CR) was defined as normalization of peripheral blood and bone marrow with <5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9/l, hemoglobin >/= 100g/l, and a platelet count >/= * 10^9/l, Partial Response (PR) was defined as transfusion independence with a peripheral blood ANC >=/ 0.05 * 10^9/l, a platelet count >/= 20 * 10^9/l, and a hemoglobin >/= 40 g/l. Hematologic improvement was defined as a clinically relevant increase in hemoglobin, platelets or absolute neutrophil count.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806598
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Tapan M. Kadia, M.D.||M.D. Anderson Cancer Center|