Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053001
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2003-01-27
Brief Title:
Thalidomide and Epoetin Alfa in Treating Anemia in Patients With Myelodysplastic Syndrome
Sponsor:
Fallon Clinic
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study on the Effectiveness of Thalomid Thalidomide Combined With Procrit Erythropoietin for the Treatment of Anemia in Patients With Low and Intermediate Risk-1 IPSS Score Less Than or Equal to 15 Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2007-10
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 Thalidomide may stop or slow the growth of cancer cells Epoetin alfa may stimulate red blood cell production Combining thalidomide with epoetin alfa may improve anemia decrease the need for blood transfusions and improve the quality of life in patients with myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of combining thalidomide with epoetin alfa in treating anemia in patients who have myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of combining thalidomide with epoetin alfa in treating anemia in patients who have myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine whether the combination of epoetin alfa and thalidomide improves the anemia andor decreases the need for red cell transfusion in patients with low- or intermediate-risk myelodysplastic syndromes
Determine whether this regimen improves the bone marrow morphology and cytogenetics alters the natural history of the disease and reduces the frequency of leukemic transformation in these patients
Evaluate whether this regimen improves pathophysiologic parameters eg apoptosis tumor necrosis factor-alpha concentration microvessel density vascular endothelial growth factor and cytotoxic T lymphocytes in the bone marrow of these patients
Determine the safety of this regimen in these patients
OUTLINE Patients receive epoetin alfa subcutaneously SC once weekly for 8 weeks After 8 weeks patients unresponsive to epoetin alfa alone receive oral thalidomide once daily in addition to epoetin alfa SC once weekly for a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30-40 patients will be accrued for this study within 2 years
Determine whether the combination of epoetin alfa and thalidomide improves the anemia andor decreases the need for red cell transfusion in patients with low- or intermediate-risk myelodysplastic syndromes
Determine whether this regimen improves the bone marrow morphology and cytogenetics alters the natural history of the disease and reduces the frequency of leukemic transformation in these patients
Evaluate whether this regimen improves pathophysiologic parameters eg apoptosis tumor necrosis factor-alpha concentration microvessel density vascular endothelial growth factor and cytotoxic T lymphocytes in the bone marrow of these patients
Determine the safety of this regimen in these patients
OUTLINE Patients receive epoetin alfa subcutaneously SC once weekly for 8 weeks After 8 weeks patients unresponsive to epoetin alfa alone receive oral thalidomide once daily in addition to epoetin alfa SC once weekly for a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30-40 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| FALLON-757 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000258753 | REGISTRY | None | None |
| CELGENE-PR01-09-010 | None | None | None |
| ORTHO-PR01-09-010 | None | None | None |