Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001839
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Randomized Trial of Antithymocyte Globulin Versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Trial of Antithymocyte Globulin Versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
1998-12
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:
Approximately 40 of the patients with myelodysplastic syndrome MDS die as a consequence of their cytopenia As in aplastic anemia the cytopenia of MDS may be partly due to cytotoxic T cell activity Immunosuppressive therapy may therefore reverse the cytopenia In a phase II pilot study of anti-thymocyte globin ATG to treat myelodysplastic syndrome MDS 41 of patients 61 of patients with refractory anemia have responded in terms of transfusion independence Recently Jonasova et al 32 reported a 82 substantial hematological response rate in 18 patients with MDS of the refractory anemia RA subtype treated with cyclosporine alone Just over 50 of the patients in this series had MDS of the hypocellular type Cyclosporine alone if indeed efficacious would be a powerful therapeutic option that could be readily used by hematologists in the community to treat patients with MDS This efficacy needs to be proven in a larger study which includes patients with the other subtypes of MDS and more patients with the non-hypocellular forms of MDS which constitute approximately 70 of the cases in the community As MDS is a heterogeneous group of disorders a randomized comparison with the other immunomodulating intervention of proven benefit ATG is appropriate In this randomized study patients with MDS will receive either ATG alone or cyclosporine alone
Detailed Description:
Approximately 40 of the patients with myelodysplastic syndrome MDS die as a consequence of their cytopenia As in aplastic anemia the cytopenia of MDS may be partly due to cytotoxic T cell activity Immunosuppressive therapy may therefore reverse the cytopenia In a phase II pilot study of anti-thymocyte globulin ATG to treat myelodysplastic syndrome MDS 41 of patients 61 of patients with refractory anemia have responded in terms of transfusion independence Recently Jonasova et al 32 reported a 82 substantial hematological response rate in 18 patients with MDS of the refractory anemia RA subtype treated with cyclosporine alone Just over 50 of the patients in this series had MDS of the hypocellular type Cyclosporine alone if indeed efficacious would be a powerful therapeutic option that could be readily used by hematologists in the community to treat patients with MDS This efficacy needs to be proven in a larger study which includes patients with the other subtypes of MDS and more patients with the non-hypocellular forms of MDS which constitute approximately 70 of the cases in the community As MDS is a heterogeneous group of disorders a randomized comparison with the other immunomodulating intervention of proven benefit ATG is appropriate In this randomized study patients with MDS will receive either ATG alone or cyclosporine alone
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 |
|---|---|---|---|
| 99-CC-0021 | None | None | None |