Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006226
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2000-09-11
Brief Title:
Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Thalidomide in Patients With Relapsed Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2013-10
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:
Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed chronic lymphocytic leukemia Thalidomide may stop the growth of chronic lymphocytic leukemia by stopping blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether thalidomide can induce objective responses in relapsed B-CLL patients
II To determine the toxicity of thalidomide in this patient population III To document if alterations in vascular growth factors andor bone marrow angiogenesis patterns correlate with thalidomide related clinical responses
OUTLINE
Patients receive oral thalidomide daily for 4 weeks Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 5 years
I To determine whether thalidomide can induce objective responses in relapsed B-CLL patients
II To determine the toxicity of thalidomide in this patient population III To document if alterations in vascular growth factors andor bone marrow angiogenesis patterns correlate with thalidomide related clinical responses
OUTLINE
Patients receive oral thalidomide daily for 4 weeks Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 5 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 |
|---|---|---|---|
| U10CA025224 | NIH | CTEP | httpsreporternihgovquickSearchU10CA025224 |
| NCI-2012-01852 | REGISTRY | None | None |
| NCCTG-N9986 | None | None | None |
| CDR0000068148 | None | None | None |
| N9986 | OTHER | None | None |
| N9986 | OTHER | None | None |