Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT00436904
Status:
COMPLETED
Last Update Posted:
2011-12-01
First Post:
2007-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Alemtuzumab and Rituximab in Treating Patients With High-Risk, Early-Stage Chronic Lymphocytic Leukemia
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Antibody Therapy With Alemtuzumab and Rituximab for Initial Treatment of High Risk Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2011-11
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: Monoclonal antibodies, such as alemtuzumab and 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 alemtuzumab together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects and how well giving alemtuzumab together with rituximab works in treating patients with high-risk, early-stage chronic lymphocytic leukemia.
PURPOSE: This phase II trial is studying the side effects and how well giving alemtuzumab together with rituximab works in treating patients with high-risk, early-stage chronic lymphocytic leukemia.
Detailed Description:
OBJECTIVES:
Primary
* Determine the rate of complete and overall response to alemtuzumab and rituximab in patients with high-risk, early-stage chronic lymphocytic leukemia.
* Determine the toxicity of this regimen in these patients. Secondary
* Determine the overall survival and time to progression of patients treated with this regimen.
* Determine time to response and duration of response in patients treated with this regimen.
* Correlate prognostic markers 11q-, 17p-, unmutated VH gene, and CD38+ with clinical outcome.
* Determine response to this regimen using an expanded definition of response that includes minimal residual disease detected by sensitive flow cytometry in patients in complete clinical remission and single rearranged IgVH gene detected by polymerase chain reaction in patients with no monoclonal population on flow cytometry.
* Correlate in vitro response with clinical outcome in patients treated with this regimen.
* Determine if alemtuzumab and rituximab are synergistic in vitro.
* Determine the mechanism of action of this regimen in vitro.
* Determine the effect of this regimen on immune function.
* Monitor T-lymphocyte, natural killer cell, and monocyte number during and after treatment in these patients.
* Serially evaluate T-lymphocyte immunophenotype and function in patients treated with this regimen.
* Monitor recovery of humoral immunity by serial serum protein electrophoresis, immunofixation electrophoresis, and immunoglobulin quantification.
OUTLINE:
* Dose-escalation (week 1): Patients receive rituximab IV on day 1 and escalating doses of alemtuzumab subcutaneously (SC) on days 3-5 in week 1.
* Treatment (weeks 2-5): Patients receive alemtuzumab SC on days 1-3 (at the highest dose administered during week 1) and rituximab IV on day 3 in weeks 2-5 in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline and periodically during study treatment for pharmacokinetic and prognostic biomarker (11q-, 17p-, unmutated IgVH, and CD38 expression by flow cytometry and fluorescent in-situ hybridization) studies. Immune function (CDR3 T-cell receptor by reverse transcriptase-polymerase chain reaction) and in vitro and in vivo response are also examined.
After completion of study therapy, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Primary
* Determine the rate of complete and overall response to alemtuzumab and rituximab in patients with high-risk, early-stage chronic lymphocytic leukemia.
* Determine the toxicity of this regimen in these patients. Secondary
* Determine the overall survival and time to progression of patients treated with this regimen.
* Determine time to response and duration of response in patients treated with this regimen.
* Correlate prognostic markers 11q-, 17p-, unmutated VH gene, and CD38+ with clinical outcome.
* Determine response to this regimen using an expanded definition of response that includes minimal residual disease detected by sensitive flow cytometry in patients in complete clinical remission and single rearranged IgVH gene detected by polymerase chain reaction in patients with no monoclonal population on flow cytometry.
* Correlate in vitro response with clinical outcome in patients treated with this regimen.
* Determine if alemtuzumab and rituximab are synergistic in vitro.
* Determine the mechanism of action of this regimen in vitro.
* Determine the effect of this regimen on immune function.
* Monitor T-lymphocyte, natural killer cell, and monocyte number during and after treatment in these patients.
* Serially evaluate T-lymphocyte immunophenotype and function in patients treated with this regimen.
* Monitor recovery of humoral immunity by serial serum protein electrophoresis, immunofixation electrophoresis, and immunoglobulin quantification.
OUTLINE:
* Dose-escalation (week 1): Patients receive rituximab IV on day 1 and escalating doses of alemtuzumab subcutaneously (SC) on days 3-5 in week 1.
* Treatment (weeks 2-5): Patients receive alemtuzumab SC on days 1-3 (at the highest dose administered during week 1) and rituximab IV on day 3 in weeks 2-5 in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline and periodically during study treatment for pharmacokinetic and prognostic biomarker (11q-, 17p-, unmutated IgVH, and CD38 expression by flow cytometry and fluorescent in-situ hybridization) studies. Immune function (CDR3 T-cell receptor by reverse transcriptase-polymerase chain reaction) and in vitro and in vivo response are also examined.
After completion of study therapy, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
True
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?: