Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017550
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2001-06-06
Brief Title:
Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
An Open Label Prospective Stratified Randomized Controlled Multi-Center Phase IIB Study of the Impact of Thymoglobulin Therapy on Transfusion Needs of Patients With Early Myelodysplastic Syndrome MDS
Status:
COMPLETED
Status Verified Date:
2003-03
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:
RATIONALE Immunosuppressive therapy may improve bone marrow abnormalities and may be effective treatment for myelodysplastic syndrome It is not yet known whether immunosuppressive therapy is more effective than supportive care in treating myelodysplastic syndrome
PURPOSE Randomized phase II trial to compare the effectiveness of antithymocyte globulin with that of supportive care in treating patients who have myelodysplastic syndrome
PURPOSE Randomized phase II trial to compare the effectiveness of antithymocyte globulin with that of supportive care in treating patients who have myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Compare the clinical response rate of patients with early myelodysplastic syndrome treated with rabbit anti-thymocyte globulin vs standard supportive care
Evaluate the safety of anti-thymocyte globulin in these patients
Compare the time to and duration of clinical response rates of partial response and therapy failure and rate of disease progression in patients treated with these regimens
Compare the ECOG performance score number of transfusions andor growth factor use and maximum time between transfusions in patients treated with these regimens
Compare the infection risk use of medical resources and quality of clinical response in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to myelodysplastic syndrome MDS subtype refractory anemia RA vs RA with excess blasts or hypocellular MDS Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive rabbit anti-thymocyte globulin ATG IV over at least 8-12 hours on days 1-4
Arm II Patients receive standard supportive therapy for 6 months At the end of 6 months patients may receive ATG as in arm I
Patients are followed for 6 months
PROJECTED ACCRUAL A total of 72 patients 48 in arm I and 24 in arm II will be accrued within a minimum of 6 months
Compare the clinical response rate of patients with early myelodysplastic syndrome treated with rabbit anti-thymocyte globulin vs standard supportive care
Evaluate the safety of anti-thymocyte globulin in these patients
Compare the time to and duration of clinical response rates of partial response and therapy failure and rate of disease progression in patients treated with these regimens
Compare the ECOG performance score number of transfusions andor growth factor use and maximum time between transfusions in patients treated with these regimens
Compare the infection risk use of medical resources and quality of clinical response in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to myelodysplastic syndrome MDS subtype refractory anemia RA vs RA with excess blasts or hypocellular MDS Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive rabbit anti-thymocyte globulin ATG IV over at least 8-12 hours on days 1-4
Arm II Patients receive standard supportive therapy for 6 months At the end of 6 months patients may receive ATG as in arm I
Patients are followed for 6 months
PROJECTED ACCRUAL A total of 72 patients 48 in arm I and 24 in arm II will be accrued within a minimum of 6 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RUSH-MDS-2000-04 | None | None | None |
| SMC-101-1020 | None | None | None |