Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098670
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2004-12-07
Brief Title:
Fludarabine Rituximab and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Fludarabine Rituximab Induction Followed by Alemtuzumab Campath-1H NSC 715969 IND 10864 Administered Subcutaneously as Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2012-12
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:
This phase II trial is studying how well giving fludarabine together with rituximab followed by alemtuzumab works in treating patients with chronic lymphocytic leukemia Monoclonal antibodies such as rituximab and alemtuzumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others can find cancer cells and help kill them or carry cancer-killing substances to them Drugs used in chemotherapy such as fludarabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving fludarabine together with rituximab followed by alemtuzumab may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the rate of complete response and toxicity of concurrent treatment with fludarabine and rituximab followed by consolidative alemtuzumab in patients with previously untreated but symptomatic CLL
II To determine if alemtuzumab improves the CR rate with acceptable toxicity when administered as consolidation therapy following induction therapy with fludarabine and rituximab
III To estimate the progression-free and overall survival of high risk VH gene unmutated and those with p53 dysfunction and low-risk others patients following therapy with fludarabine and rituximab induction and consolidative alemtuzumab
IV To determine the frequency of molecular PCR remission following fludarabine and rituximab induction therapy and alemtuzumab consolidation therapy and if this serves as a surrogate marker for prolonged progression-free and overall survival
SECONDARY OBJECTIVES
I To determine the effect of concurrent treatment with fludarabine and rituximab followed by consolidative alemtuzumab on recovery of T-cells NK cells and serum immunoglobulin levels
II To determine clinical and molecular features that predict for poor response to fludarabine and rituximab induction and subsequent alemtuzumab consolidation therapy
III To assess preliminarily the molecular features of CLL at relapse in patients responding to chemoimmunotherapy for CLL
IV To determine the frequency of patients who remain at high risk for progression of CLL despite this therapy and who are thus eligible for nonmyeloablative stem cell transplantation studies such as CALGB 109901
V To perform limited rituximab pharmacokinetics to determine the ideal schedule of administration for a subsequent rituximab maintenance treatment approach following induction therapy with fludarabine and rituximab
OUTLINE
Patients receive induction therapy comprising rituximab IV over 4 hours on days 1 3 and 5 of course 1 and day 1 of all subsequent courses and fludarabine IV over 30 minutes on days 1-5 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression
Approximately 4 months after completion of induction therapy patients achieving a partial response nodular partial response or stable disease receive consolidation therapy comprising alemtuzumab subcutaneously on days 1-3 Treatment repeats weekly for up to 6 courses in the absence of disease progression
Patients are followed at 2 months every 3 months for 1 year and then every 6 months for 7 years from study entry
I To determine the rate of complete response and toxicity of concurrent treatment with fludarabine and rituximab followed by consolidative alemtuzumab in patients with previously untreated but symptomatic CLL
II To determine if alemtuzumab improves the CR rate with acceptable toxicity when administered as consolidation therapy following induction therapy with fludarabine and rituximab
III To estimate the progression-free and overall survival of high risk VH gene unmutated and those with p53 dysfunction and low-risk others patients following therapy with fludarabine and rituximab induction and consolidative alemtuzumab
IV To determine the frequency of molecular PCR remission following fludarabine and rituximab induction therapy and alemtuzumab consolidation therapy and if this serves as a surrogate marker for prolonged progression-free and overall survival
SECONDARY OBJECTIVES
I To determine the effect of concurrent treatment with fludarabine and rituximab followed by consolidative alemtuzumab on recovery of T-cells NK cells and serum immunoglobulin levels
II To determine clinical and molecular features that predict for poor response to fludarabine and rituximab induction and subsequent alemtuzumab consolidation therapy
III To assess preliminarily the molecular features of CLL at relapse in patients responding to chemoimmunotherapy for CLL
IV To determine the frequency of patients who remain at high risk for progression of CLL despite this therapy and who are thus eligible for nonmyeloablative stem cell transplantation studies such as CALGB 109901
V To perform limited rituximab pharmacokinetics to determine the ideal schedule of administration for a subsequent rituximab maintenance treatment approach following induction therapy with fludarabine and rituximab
OUTLINE
Patients receive induction therapy comprising rituximab IV over 4 hours on days 1 3 and 5 of course 1 and day 1 of all subsequent courses and fludarabine IV over 30 minutes on days 1-5 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression
Approximately 4 months after completion of induction therapy patients achieving a partial response nodular partial response or stable disease receive consolidation therapy comprising alemtuzumab subcutaneously on days 1-3 Treatment repeats weekly for up to 6 courses in the absence of disease progression
Patients are followed at 2 months every 3 months for 1 year and then every 6 months for 7 years from study entry
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 |
|---|---|---|---|
| U10CA031946 | NIH | CTEP | httpsreporternihgovquickSearchU10CA031946 |
| NCI-2012-02812 | REGISTRY | None | None |
| CDR0000398139 | None | None | None |
| CALGB-10101 | OTHER | None | None |
| CALGB-10101 | OTHER | None | None |
| P30CA014236 | NIH | None | None |