Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-30 @ 11:10 PM
Study NCT ID:
NCT00812669
Status:
COMPLETED
Last Update Posted:
2025-07-08
First Post:
2008-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLL-Irl Study. CTRIAL-IE (ICORG) 07-01, V7
Sponsor:
Cancer Trials Ireland
Organization:
Study Overview
Official Title:
An Open-label Phase II Study of the Efficacy and Safety of the Combination of Fludarabine, Cyclophosphamide and Rituximab in Patients With Chronic Lymphocytic Leukaemia Who Are Newly Diagnosed, Have Relapsed or Are Resistant to First-Line Treatment
Status:
COMPLETED
Status Verified Date:
2025-07
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 and cyclophosphamide, 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 fludarabine together with cyclophosphamide and rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works in treating patients with chronic lymphocytic leukemia.
PURPOSE: This phase II trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works in treating patients with chronic lymphocytic leukemia.
Detailed Description:
OBJECTIVES:
Primary
* Evaluate the efficacy, in terms of complete remission rate, of fludarabine phosphate, cyclophosphamide, and rituximab in patients with chronic lymphocytic leukemia.
Secondary
* Determine the time to treatment failure (TTF) in these patients.
* Determine the overall survival of these patients until 10th January 2019.
* Assess the predictive value of immunophenotype, hypermutation analysis, and FISH in determining TTF and OS in these patients.
* Determine the safety profile of this regimen.
OUTLINE: This is a multicenter study.
Patients receive fludarabine IV over 30 minutes or orally and cyclophosphamide IV or orally on days 1-3 and pegfilgrastim subcutaneously on day 4. Starting on course 2, patients receive rituximab IV on day 1. Treatment repeats every 28 days for up to 6\* courses in the absence of disease progression or unacceptable toxicity.
NOTE: \*Patients achieving negative minimal residual disease receive 4 courses of treatment.
Blood samples are collected periodically for biomarker analysis. Samples are analyzed for protein expression (i.e., CD38, CD20, and ZAP70) by flow cytometry; quantitative immunoglobulins, β2-microglobulin, and T-cell subsets by electrophoresis; IgVH mutation status; and cytogenetics (i.e., +12, del 13q, del 11q, and del 17p) by FISH.
After completion of study therapy, patients are followed every 6 months for 5 years and then annually until 10th January 2019.
Primary
* Evaluate the efficacy, in terms of complete remission rate, of fludarabine phosphate, cyclophosphamide, and rituximab in patients with chronic lymphocytic leukemia.
Secondary
* Determine the time to treatment failure (TTF) in these patients.
* Determine the overall survival of these patients until 10th January 2019.
* Assess the predictive value of immunophenotype, hypermutation analysis, and FISH in determining TTF and OS in these patients.
* Determine the safety profile of this regimen.
OUTLINE: This is a multicenter study.
Patients receive fludarabine IV over 30 minutes or orally and cyclophosphamide IV or orally on days 1-3 and pegfilgrastim subcutaneously on day 4. Starting on course 2, patients receive rituximab IV on day 1. Treatment repeats every 28 days for up to 6\* courses in the absence of disease progression or unacceptable toxicity.
NOTE: \*Patients achieving negative minimal residual disease receive 4 courses of treatment.
Blood samples are collected periodically for biomarker analysis. Samples are analyzed for protein expression (i.e., CD38, CD20, and ZAP70) by flow cytometry; quantitative immunoglobulins, β2-microglobulin, and T-cell subsets by electrophoresis; IgVH mutation status; and cytogenetics (i.e., +12, del 13q, del 11q, and del 17p) by FISH.
After completion of study therapy, patients are followed every 6 months for 5 years and then annually until 10th January 2019.
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?: