Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004208
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2000-01-21
Brief Title:
Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Antithymocyte Globulin ATG and Cyclosporine CSA to Treat Patients With Myelodysplastic Syndrome MDS A Randomized Trial Comparing ATG CSA With Best Supportive Care
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this trial is to evaluate the efficacy and toxicity of intensive immuno-suppression with ATG CSA versus best supportive care in patients with transfusion dependent low and intermediate risk myelodysplastic syndrome MDS
Detailed Description:
This trial will answer the question whether immuno-suppression improves hematopoesis and reduces transfusion requirements analogous to patients with aplastic anemia as the short-term outcome and whether immuno-suppression accelerates leukemic transformation and influences survival as the long-term outcome
Primary endpoint best response CR PR rate at month 6
Primary endpoint best response CR PR rate at month 6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SWS-SAKK-3399 | OTHER | SAKK | None |