Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201721
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2005-09-12
Brief Title:
Pentostatin and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial of Pentostatin and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia CLL
Status:
COMPLETED
Status Verified Date:
2017-02
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 study aims to assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide to monitor and assess toxicity of this regimen and to determine the overall and progression-free survival in CLL patients
Detailed Description:
Rationale Research indicates that both cyclophosphamide and pentostatin work synergistically against cancer cells and have a high response rate against chronic lymphocytic leukemia CLL without creating severe side effects in patients In addition studies have shown that rituximab a therapy that targets the immune system has the highest efficacy against CLL and the lowest toxicity rate when compared with other immunotherapy drugs Studies also show that rituximab enhances the efficacy of the chemotherapy agents cyclophosphamide and pentostatin This study offers the combination of immunotherapy with two promising chemotherapy agents against CLL
Purpose This study is evaluating the efficacy and safety of combination treatment with cyclophosphamide pentostatin and rituximab in patients with CLL Several tests evaluating the genetic and molecular components of CLL will also be performed Some of these tests will be conducted before during and after treatments to assess changes resulting from the study drugs Each patients outcome will be assessed in relation to various aspects of their genes
Purpose This study is evaluating the efficacy and safety of combination treatment with cyclophosphamide pentostatin and rituximab in patients with CLL Several tests evaluating the genetic and molecular components of CLL will also be performed Some of these tests will be conducted before during and after treatments to assess changes resulting from the study drugs Each patients outcome will be assessed in relation to various aspects of their genes
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