Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003681
Status:
UNKNOWN
Last Update Posted:
2009-05-12
First Post:
1999-11-01
Brief Title:
Amifostine With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Multicenter Study of Amifostine in Patients With Myelodysplastic Syndromes at Relatively Low Risk of Developing Acute Leukemia
Status:
UNKNOWN
Status Verified Date:
2000-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Amifostine may improve blood counts in patients with myelodysplastic syndrome Epoetin alfa may stimulate red blood cell production and be an effective treatment for anemia in patients with myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of amifostine with or without epoetin alfa in treating patients who have myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of amifostine with or without epoetin alfa in treating patients who have myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Compare the effect of amifostine alone and in combination with epoetin alfa on bone marrow progenitor cells and number of blast cells blood leukocyte counts reticulocytes hemoglobin level and platelet counts as well as peripheral blood and bone marrow blast cell count in patients with myelodysplastic syndromes at a low risk of developing acute leukemia II Determine partial or complete response and duration of response in this patient population III Characterize the subjective and objective toxicity of amifostine in these patients
OUTLINE This is a multicenter study Patients receive amifostine IV 3 times per week for 3 weeks followed by 1 week of rest Response is assessed after 2 courses of therapy Treatment continues in the absence of disease progression Patients with complete response receive 1 additional course Patients with partial response or stable disease are stratified into 2 groups Group 1 Patients with hemoglobin of at least 10 gdL without transfusion receive 2 additional courses of amifostine alone Group 2 Patients with hemoglobin less than 10 gdL or who are transfusion dependent receive 2 additional courses of amifostine in combination with epoetin alfa subcutaneously 3 times per week Both groups are reevaluated after these 2 additional courses Treatment may then continue at the discretion of the treating physician Patients are followed every 3 months
PROJECTED ACCRUAL A total of 27-50 patients will be accrued to this study within 13 years
OUTLINE This is a multicenter study Patients receive amifostine IV 3 times per week for 3 weeks followed by 1 week of rest Response is assessed after 2 courses of therapy Treatment continues in the absence of disease progression Patients with complete response receive 1 additional course Patients with partial response or stable disease are stratified into 2 groups Group 1 Patients with hemoglobin of at least 10 gdL without transfusion receive 2 additional courses of amifostine alone Group 2 Patients with hemoglobin less than 10 gdL or who are transfusion dependent receive 2 additional courses of amifostine in combination with epoetin alfa subcutaneously 3 times per week Both groups are reevaluated after these 2 additional courses Treatment may then continue at the discretion of the treating physician Patients are followed every 3 months
PROJECTED ACCRUAL A total of 27-50 patients will be accrued to this study within 13 years
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 |
|---|---|---|---|
| EORTC-06975 | None | None | None |