Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003764
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
1999-11-01
Brief Title:
Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase III Randomized Trial of Fludarabine and Cyclophosphamide Versus Fludarabine for Previously Untreated 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 Combining more than one drug may kill more cancer cells It is not yet known whether combining cyclophosphamide with fludarabine is more effective than fludarabine alone in treating chronic lymphocytic leukemia
PURPOSE Randomized phase III trial to study the effectiveness of fludarabine with or without cyclophosphamide in treating patients who have chronic lymphocytic leukemia that has not been treated previously
PURPOSE Randomized phase III trial to study the effectiveness of fludarabine with or without cyclophosphamide in treating patients who have chronic lymphocytic leukemia that has not been treated previously
Detailed Description:
OBJECTIVES
Compare the efficacy of fludarabine with or without cyclophosphamide in terms of complete remission rate and overall survival in patients with previously untreated B cell chronic lymphocytic leukemia CLL
Compare the toxicities of these 2 regimens in this patient population
Determine whether the expression of proteins specifically implicated in the regulation of DNA damage induced apoptosis of lymphoid cells ie p53 mdm2 GST Bcl-2 Mcl-1 Bax p27 and caspase-3 correlates with response to chemotherapy in these patients
Determine whether there is a relationship between clinical response or resistance and differential expression of genes in the CLL cells either at initiation of therapy or following relapse and progression
Correlate mutations in immunoglobulin heavy chain variable region genes with clinical response or resistance in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to stage of disease O-II vs III-IV Patients are randomized to one of two treatment arms
Arm I Patients receive fludarabine IV over 30 minutes on days 1-5
Arm II Patients receive fludarabine as in arm I plus cyclophosphamide IV over 1 hour on day 1
Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 280 patients will be accrued for this study over 2 to 25 years
Compare the efficacy of fludarabine with or without cyclophosphamide in terms of complete remission rate and overall survival in patients with previously untreated B cell chronic lymphocytic leukemia CLL
Compare the toxicities of these 2 regimens in this patient population
Determine whether the expression of proteins specifically implicated in the regulation of DNA damage induced apoptosis of lymphoid cells ie p53 mdm2 GST Bcl-2 Mcl-1 Bax p27 and caspase-3 correlates with response to chemotherapy in these patients
Determine whether there is a relationship between clinical response or resistance and differential expression of genes in the CLL cells either at initiation of therapy or following relapse and progression
Correlate mutations in immunoglobulin heavy chain variable region genes with clinical response or resistance in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to stage of disease O-II vs III-IV Patients are randomized to one of two treatment arms
Arm I Patients receive fludarabine IV over 30 minutes on days 1-5
Arm II Patients receive fludarabine as in arm I plus cyclophosphamide IV over 1 hour on day 1
Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 280 patients will be accrued for this study over 2 to 25 years
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 |
|---|---|---|---|
| SWOG-E2997 | None | None | None |
| E2997 | None | None | None |
| CALGB-10103 | None | None | None |