Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003808
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Theophylline in Treating Patients With In Situ Stage I or Stage II Chronic Lymphocytic Leukemia
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of Theophylline in Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2023-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of theophylline in treating patients who have in situ stage I or stage II chronic lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of theophylline in treating patients who have in situ stage I or stage II chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES I Determine the response rate in asymptomatic patients with stage 0 I or II B-cell chronic lymphocytic leukemia treated with theophylline II Determine the toxicity of this treatment in these patients
OUTLINE Patients receive oral theophylline daily Daily treatment continues for a maximum of 6 months in the absence of disease progression or unacceptable toxicity Patients are followed every 4 months for 1 year
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study over approximately 10 months
OUTLINE Patients receive oral theophylline daily Daily treatment continues for a maximum of 6 months in the absence of disease progression or unacceptable toxicity Patients are followed every 4 months for 1 year
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study over approximately 10 months
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 |
|---|---|---|---|
| NCCTG-988151 | None | None | None |
| E-4998 | None | None | None |