Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337246
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2006-06-13
Brief Title:
Combination Chemotherapy With or Without Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia
Sponsor:
Cancer Research UK
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Trial of Fludarabine Cyclophosphamide and Mitoxantrone FCM With or Without Rituximab in Previously Treated Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2007-05
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 such as fludarabine cyclophosphamide and mitoxantrone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Giving combination chemotherapy together with rituximab may kill more cancer cells It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating chronic lymphocytic leukemia
PURPOSE This randomized phase II trial is studying how well giving combination chemotherapy with or without rituximab works in treating patients with previously treated chronic lymphocytic leukemia
PURPOSE This randomized phase II trial is studying how well giving combination chemotherapy with or without rituximab works in treating patients with previously treated chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Primary
Assess the efficacy and safety of fludarabine cyclophosphamide and mitoxantrone hydrochloride with or without rituximab in patients with previously treated chronic lymphocytic leukemia
Determine the overall response rate defined as complete or partial remission in these patients
Secondary
Determine the proportion of patients with undetectable minimal residual disease
Determine the 2-year progression-free survival of these patients
Determine the 2-year overall survival of these patients
Determine the toxicity of this regimen
OUTLINE This is a randomized controlled open-label parallel group multicenter study Patients are stratified according to prior treatment with fludarabine refractory vs not refractory or naive Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral fludarabine and oral cyclophosphamide on days 1-5 and mitoxantrone hydrochloride IV on day 1
Arm II Patients receive fludarabine cyclophosphamide and mitoxantrone hydrochloride as in arm I Patients also receive rituximab IV on day 1
NOTE If the oral regimen is not tolerated patients may receive fludarabine IV and cyclophosphamide IV on days 1-3
Treatment in both arms repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 3 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 56 patients will be accrued for this study
Primary
Assess the efficacy and safety of fludarabine cyclophosphamide and mitoxantrone hydrochloride with or without rituximab in patients with previously treated chronic lymphocytic leukemia
Determine the overall response rate defined as complete or partial remission in these patients
Secondary
Determine the proportion of patients with undetectable minimal residual disease
Determine the 2-year progression-free survival of these patients
Determine the 2-year overall survival of these patients
Determine the toxicity of this regimen
OUTLINE This is a randomized controlled open-label parallel group multicenter study Patients are stratified according to prior treatment with fludarabine refractory vs not refractory or naive Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral fludarabine and oral cyclophosphamide on days 1-5 and mitoxantrone hydrochloride IV on day 1
Arm II Patients receive fludarabine cyclophosphamide and mitoxantrone hydrochloride as in arm I Patients also receive rituximab IV on day 1
NOTE If the oral regimen is not tolerated patients may receive fludarabine IV and cyclophosphamide IV on days 1-3
Treatment in both arms repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 3 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 56 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT-2004-003982-34 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000485181 | REGISTRY | None | None |
| EU-20626 | None | None | None |
| ROCHE-NCRI-UKCLL01-FCMFCM-R | None | None | None |
| ISRCTN77546448 | None | None | None |