Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003829
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of Alternating Cycles of Fludarabine and Cyclophosphamide in Previously Untreated Patients With B-cell CLL
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 Alternating treatment with more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of fludarabine alternating with cyclophosphamide in treating patients who have previously untreated chronic lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of fludarabine alternating with cyclophosphamide in treating patients who have previously untreated chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES I Determine the rate and duration of complete and partial remissions in patients with previously untreated B-cell chronic lymphocytic leukemia after treatment with alternating courses of fludarabine and cyclophosphamide II Monitor and assess toxicity of this regimen in these patients III Utilize molecular genetic studies and flow cytometry on peripheral blood cells from patients achieving complete remission by conventional criteria IV Apply FISH techniques using probes to chromosomes 12 and 13 as prognostic factors for time to progression and overall survival of these patients
OUTLINE Patients receive alternating courses of fludarabine and cyclophosphamide Fludarabine is administered IV over 10-30 minutes on days 1-5 of courses 1 3 and 5 Cyclophosphamide is administered IV over 30-60 minutes on day 1 of courses 2 4 and 6 Treatment repeats every 4 weeks Patients achieving clinical complete remission CCR after 6 courses of chemotherapy receive 2 additional courses one course of each drug Patients achieving partial remission after 6 courses of chemotherapy also receive 2 additional courses If these patients then achieve CCR they receive another 2 courses Patients are followed every 3 months
OUTLINE Patients receive alternating courses of fludarabine and cyclophosphamide Fludarabine is administered IV over 10-30 minutes on days 1-5 of courses 1 3 and 5 Cyclophosphamide is administered IV over 30-60 minutes on day 1 of courses 2 4 and 6 Treatment repeats every 4 weeks Patients achieving clinical complete remission CCR after 6 courses of chemotherapy receive 2 additional courses one course of each drug Patients achieving partial remission after 6 courses of chemotherapy also receive 2 additional courses If these patients then achieve CCR they receive another 2 courses Patients are followed every 3 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 |
|---|---|---|---|
| NCI-2012-02296 | REGISTRY | CTRP Clinical Trials Reporting System | None |
| NCCTG-978151 | None | None | None |
| CDR0000066985 | REGISTRY | None | None |