Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005829
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2000-06-02
Brief Title:
Gemcitabine in Treating Patients With Recurrent Chronic Lymphocytic Leukemia
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Study of Gemcitabine for Relapsed B-Cell Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2016-12
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 gemcitabine in treating patients who have recurrent chronic lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of gemcitabine in treating patients who have recurrent chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES I Determine the rate and duration of complete and partial remission in patients with recurrent B-cell chronic lymphocytic leukemia treated with gemcitabine II Assess the toxicities of this regimen in these patients
OUTLINE Patients receive gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 4 weeks for a minimum of 3 courses Patients achieving clinical complete remission complete remission nodular partial remission or partial remission following 3 courses of therapy receive 2 additional courses of therapy Patients achieving complete remission or further improvement following the 2 additional courses of therapy receive another 2 courses of therapy Patients are followed every 3 months until disease progression or relapse Patients achieving complete remission are followed every 6 months for 1 year
OUTLINE Patients receive gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 4 weeks for a minimum of 3 courses Patients achieving clinical complete remission complete remission nodular partial remission or partial remission following 3 courses of therapy receive 2 additional courses of therapy Patients achieving complete remission or further improvement following the 2 additional courses of therapy receive another 2 courses of therapy Patients are followed every 3 months until disease progression or relapse Patients achieving complete remission are followed every 6 months for 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 |
|---|---|---|---|
| NCI-2012-02331 | REGISTRY | CTRP Clinical Trials Reporting System | None |
| NCCTG-988152 | None | None | None |
| CDR0000067843 | REGISTRY | None | None |