Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049075
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2002-11-12
Brief Title:
Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2020-04
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 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 fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated
PURPOSE Phase II trial to study the effectiveness of fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated
Detailed Description:
OBJECTIVES
Determine the overall response rate complete and partial in patients with previously untreated B-cell chronic lymphocytic leukemia treated with oral fludarabine
Determine the molecular complete response rate in patients who achieve a clinical or immunophenotypic complete response when treated with this drug
Determine the progression-free and treatment-free survival of patients treated with this drug
Determine the toxicity of this drug in these patients
Determine the baseline incidence of defined genetic abnormalities in patients treated with this drug
Determine the prognostic and predictive significance of defined genetic abnormalities in patients with respect to response to treatment with this drug
Determine the prognostic and predictive significance of immunophenotypic profile of patients with respect to response to treatment with this drug
OUTLINE This is a multicenter study
Patients receive oral fludarabine on days 1-5 Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity Patients in complete remission after 6 courses do not receive further study therapy
Patients are followed at 2 months and then every 4 months for 2 years
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study within 2 years
Determine the overall response rate complete and partial in patients with previously untreated B-cell chronic lymphocytic leukemia treated with oral fludarabine
Determine the molecular complete response rate in patients who achieve a clinical or immunophenotypic complete response when treated with this drug
Determine the progression-free and treatment-free survival of patients treated with this drug
Determine the toxicity of this drug in these patients
Determine the baseline incidence of defined genetic abnormalities in patients treated with this drug
Determine the prognostic and predictive significance of defined genetic abnormalities in patients with respect to response to treatment with this drug
Determine the prognostic and predictive significance of immunophenotypic profile of patients with respect to response to treatment with this drug
OUTLINE This is a multicenter study
Patients receive oral fludarabine on days 1-5 Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity Patients in complete remission after 6 courses do not receive further study therapy
Patients are followed at 2 months and then every 4 months for 2 years
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000257836 | OTHER | PDQ | None |
| CAN-NCIC-CL2 | OTHER | None | None |
| BRLX-304160 | OTHER | None | None |