Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009984
Status:
TERMINATED
Last Update Posted:
2013-06-06
First Post:
2001-02-02
Brief Title:
Thalidomide With or Without Fludarabine in Treating Patients With Hematologic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase II Study of Thalidomide Versus Thalidomide Plus Fludarabine for Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine
Status:
TERMINATED
Status Verified Date:
2013-06
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:
This randomized phase II trial is studying thalidomide and fludarabine to see how well they work compared to thalidomide alone in treating patients with hematologic cancer that has not responded to previous treatment with fludarabine Thalidomide may stop the growth of hematologic cancer by stopping blood flow to the cancer Combining thalidomide with fludarabine may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drug It is not yet known whether thalidomide is more effective with or without fludarabine for hematologic cancer
Detailed Description:
OBJECTIVES
I Compare the safety and tolerability of thalidomide with or without fludarabine in patients with fludarabine-refractory chronic lymphocytic leukemia or small lymphocytic lymphoma
II Compare the incidence of complete and partial remission in patients treated with these regimens
OUTLINE This is a randomized open-label study Patients are stratified according to time to relapse from last fludarabine treatment less than 6 months vs more than 6 months Patients are randomized to one of two treatment arms
Arm I Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity
Arm II Patients receive thalidomide as in arm I and fludarabine IV over 30 minutes on days 1-5 Treatment with fludarabine repeats every 28 days for 6 courses Once fludarabine is completed patients continue to receive thalidomide alone as in arm I
PROJECTED ACCRUAL A total of 24-70 patients 12-35 per treatment arm will be accrued for this study within 1 year
I Compare the safety and tolerability of thalidomide with or without fludarabine in patients with fludarabine-refractory chronic lymphocytic leukemia or small lymphocytic lymphoma
II Compare the incidence of complete and partial remission in patients treated with these regimens
OUTLINE This is a randomized open-label study Patients are stratified according to time to relapse from last fludarabine treatment less than 6 months vs more than 6 months Patients are randomized to one of two treatment arms
Arm I Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity
Arm II Patients receive thalidomide as in arm I and fludarabine IV over 30 minutes on days 1-5 Treatment with fludarabine repeats every 28 days for 6 courses Once fludarabine is completed patients continue to receive thalidomide alone as in arm I
PROJECTED ACCRUAL A total of 24-70 patients 12-35 per treatment arm will be accrued for this study within 1 year
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 |
|---|---|---|---|
| N01CM62204 | NIH | None | httpsreporternihgovquickSearchN01CM62204 |
| NYWCCC-MTS-00-0535ME | None | None | None |
| CDR0000068429 | None | None | None |
| NCI-639 | None | None | None |