Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052416
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2003-01-24
Brief Title:
Thalidomide in Treating Patients With Asymptomatic Indolent Non-Hodgkins Lymphoma or Chronic Lymphocytic Leukemia
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Thalidomide in Indolent Non-Hodgkins Lymphoma A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2003-04
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 the growth of cancer by stopping blood flow to the tumor
PURPOSE Phase I trial to determine the effectiveness of thalidomide in treating patients who have asymptomatic indolent non-Hodgkins lymphoma or chronic lymphocytic leukemia
PURPOSE Phase I trial to determine the effectiveness of thalidomide in treating patients who have asymptomatic indolent non-Hodgkins lymphoma or chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the feasibility in terms of toxicity and patient compliance of thalidomide in patients with asymptomatic indolent non-Hodgkins lymphoma or chronic lymphocytic leukemia
Determine the event-free and progression-free survival of patients treated with this drug
Determine disease response and time to next treatment in patients treated with this drug
Determine the quality of life of patients treated with this drug
OUTLINE Patients receive oral thalidomide once daily Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline monthly during study and at the end of the study
PROJECTED ACCRUAL A total of 30-36 patients will be accrued for this study within 2 years
Determine the feasibility in terms of toxicity and patient compliance of thalidomide in patients with asymptomatic indolent non-Hodgkins lymphoma or chronic lymphocytic leukemia
Determine the event-free and progression-free survival of patients treated with this drug
Determine disease response and time to next treatment in patients treated with this drug
Determine the quality of life of patients treated with this drug
OUTLINE Patients receive oral thalidomide once daily Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline monthly during study and at the end of the study
PROJECTED ACCRUAL A total of 30-36 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 |
|---|---|---|---|
| NCI-V02-1714 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000258419 | REGISTRY | None | None |
| NEDH-W-01-0384-FB | None | None | None |
| BIDMC-2001-P-001950 | None | None | None |