Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001586
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
1999-11-03
Brief Title:
Treatment of Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma CLLSLL DNA Microarray Gene Expression Analysis
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma CLLSLL DNA Microarray Gene Expression Analysis
Status:
COMPLETED
Status Verified Date:
2013-03
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:
Background
Combined therapy with rituximab and fludarabine is the treatment of choice for advanced stage chronic lymphocytic leukemiasmall lymphocytic lymphoma CLLSLL
A new technology called deoxyribonucleic acid DNA microarray can be used to gain knowledge about the genetic basis of CLLSLL
Genetic studies of CLLSLL may improve our understanding of what happens in the disease help determine which patients are most likely to respond to treatment with fludarabine and rituximab and identify new treatments
Objectives
-To gain further knowledge about CLLSLL and the role of rituximab and fludarabine in treating the disease
Eligibility
-Patients 18 years of age and older with low intermediate or high-risk CLLSLL
Design
Patients with low-risk CLLSLL do not receive treatment but are followed every 3 to 6 months and donate cells through apheresis or lymph nodes or both for research purposes
Patients with intermediate or high-risk CLLSLL receive standard treatment with rituximab and fludarabine for six 28-day treatment cycles Rituximab is given on day 1 and fludarabine is given on days 1-5 For the first cycle only fludarabine treatment starts on day 2 This delay permits blood sampling on day 1 for the effect of rituximab on white blood cells
Laboratory tests and imaging studies are done periodically to monitor drug side effects and the response to treatment Tests include bone marrow biopsy and aspiration blood tests and x-rays including positron emission tomography PET and computed tomography CT scans
Combined therapy with rituximab and fludarabine is the treatment of choice for advanced stage chronic lymphocytic leukemiasmall lymphocytic lymphoma CLLSLL
A new technology called deoxyribonucleic acid DNA microarray can be used to gain knowledge about the genetic basis of CLLSLL
Genetic studies of CLLSLL may improve our understanding of what happens in the disease help determine which patients are most likely to respond to treatment with fludarabine and rituximab and identify new treatments
Objectives
-To gain further knowledge about CLLSLL and the role of rituximab and fludarabine in treating the disease
Eligibility
-Patients 18 years of age and older with low intermediate or high-risk CLLSLL
Design
Patients with low-risk CLLSLL do not receive treatment but are followed every 3 to 6 months and donate cells through apheresis or lymph nodes or both for research purposes
Patients with intermediate or high-risk CLLSLL receive standard treatment with rituximab and fludarabine for six 28-day treatment cycles Rituximab is given on day 1 and fludarabine is given on days 1-5 For the first cycle only fludarabine treatment starts on day 2 This delay permits blood sampling on day 1 for the effect of rituximab on white blood cells
Laboratory tests and imaging studies are done periodically to monitor drug side effects and the response to treatment Tests include bone marrow biopsy and aspiration blood tests and x-rays including positron emission tomography PET and computed tomography CT scans
Detailed Description:
Background
Due to their synergistic action and non-overlapping toxicity profiles the combination of Rituximab and Fludarabine is the treatment of choice for advanced stage chronic lymphocytic lymphoma CLLsmall lymphocytic lymphoma SLL
As such we have designed this protocol to better understand the genetic basis of CLLSLL to identify predictors of treatment response and to study the molecular effects of Rituximab Fludarabine on the leukemic cells
A new technology utilizing complementary deoxyribonucleic acid cDNA microarrays now permits the simultaneous quantitation of the expression of thousands of genes this methodology can evaluate defined cellular pathways and also discover novel genes influencing cell biology
In addition to improving our understanding of the pathogenesis of CLLSLL these molecular studies may identify new therapeutic targets in CLLSLL and may help to identify those CLLSLL patients most likely to respond to the combination of Fludarabine and Rituximab
Objectives
Evaluate CLLSLL patients during and following Rituximab Fludarabine chemotherapy for changes in lymphocyte gene expression using DNA microarray analysis
Evaluate gene expression by DNA microarray analysis of leukemic cells in blood bone marrow and lymph nodes
Eligibility
Low Intermediate or High-Risk Category of CLLSLL using the Modified Three- Stage Rai Staging System
Age greater than or equal to 18 years
Patients must have received no previous cytotoxic or monoclonal antibody therapy
Eastern Cooperative Oncology Group ECOG performance status of 0-2
Patients must not be pregnant or breast-feeding
Patients with active autoimmune hemolytic anemia AIHA grade III or higher transfusion or steroids indicated or immune thrombocytopenia ITP grade III or higher platelets less than 50000microL shall not be enrolled
Any patient with a medical condition that requires chronic use of corticosteroids shall not be enrolled
Design
Patients who do not require treatment will be followed every 3-6 months and will donate cellular products bone marrow biopsies bone marrow aspirates andor lymph nodes for research purposes
Patients who do require treatment will received the standard dose of the Rituximab monoclonal antibody and the standard dose of Fludarabine for a total of six cycles In the first cycle Rituximab will be given on day 1 with Fludarabine being given on days 2-6 This will allow for appropriate samplings of the effects of Rituximab on lymphocytes before during and at the end of the first 24 hours In subsequent cycles 2-6 the Rituximab and day 1 Fludarabine can both be given on day 1
Due to their synergistic action and non-overlapping toxicity profiles the combination of Rituximab and Fludarabine is the treatment of choice for advanced stage chronic lymphocytic lymphoma CLLsmall lymphocytic lymphoma SLL
As such we have designed this protocol to better understand the genetic basis of CLLSLL to identify predictors of treatment response and to study the molecular effects of Rituximab Fludarabine on the leukemic cells
A new technology utilizing complementary deoxyribonucleic acid cDNA microarrays now permits the simultaneous quantitation of the expression of thousands of genes this methodology can evaluate defined cellular pathways and also discover novel genes influencing cell biology
In addition to improving our understanding of the pathogenesis of CLLSLL these molecular studies may identify new therapeutic targets in CLLSLL and may help to identify those CLLSLL patients most likely to respond to the combination of Fludarabine and Rituximab
Objectives
Evaluate CLLSLL patients during and following Rituximab Fludarabine chemotherapy for changes in lymphocyte gene expression using DNA microarray analysis
Evaluate gene expression by DNA microarray analysis of leukemic cells in blood bone marrow and lymph nodes
Eligibility
Low Intermediate or High-Risk Category of CLLSLL using the Modified Three- Stage Rai Staging System
Age greater than or equal to 18 years
Patients must have received no previous cytotoxic or monoclonal antibody therapy
Eastern Cooperative Oncology Group ECOG performance status of 0-2
Patients must not be pregnant or breast-feeding
Patients with active autoimmune hemolytic anemia AIHA grade III or higher transfusion or steroids indicated or immune thrombocytopenia ITP grade III or higher platelets less than 50000microL shall not be enrolled
Any patient with a medical condition that requires chronic use of corticosteroids shall not be enrolled
Design
Patients who do not require treatment will be followed every 3-6 months and will donate cellular products bone marrow biopsies bone marrow aspirates andor lymph nodes for research purposes
Patients who do require treatment will received the standard dose of the Rituximab monoclonal antibody and the standard dose of Fludarabine for a total of six cycles In the first cycle Rituximab will be given on day 1 with Fludarabine being given on days 2-6 This will allow for appropriate samplings of the effects of Rituximab on lymphocytes before during and at the end of the first 24 hours In subsequent cycles 2-6 the Rituximab and day 1 Fludarabine can both be given on day 1
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 |
|---|---|---|---|
| 97-C-0178 | None | None | None |