Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201877
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2005-09-12
Brief Title:
Velcade Bortezomib PS-341 and Rituximab in RelapsedRefractory Mantle Cell and Follicular Non-Hodgkins Lymphoma
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Velcade Bortezomib PS-341 and Rituximab in RelapsedRefractory Mantle Cell and Follicular Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-03
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:
This study will determine the overall response rate and toxicity of rituximab and Velcade in combination in patients with relapsed or refractory mantle cell non-Hodgkins lymphoma
Detailed Description:
Rationale Previous studies testing bortezomib and rituximab separately indicate these agents have some efficacy against mantle cell lymphoma MCL Bortezomib is a targeted cancer drug that blocks proteasomes The proteasome is an enzyme complex existing in all cells that influences proteins controlling cellular processes By blocking the proteasome bortezomib disrupts biologic pathways such as those related to the growth and survival of cancer cells Rituximab is a monoclonal antibody that attaches to a protein called the CD20 antigen that is found almost exclusively on the surface of B-cells with leukemia Once rituximab attaches to the protein the immune system activates to kill the malignant B-cells The current study combines bortezomib and rituximab in patients with relapsed or refractory MCL
Purpose This study will evaluate the safety and efficacy of bortezomib and rituximab in patients with relapsed or refractory MCL Blood molecular and tumor analysis will be conducted to provide researchers with information about areas such as rituximab resistance the effects of bortezomib on cells associated with immune function and protein alterations related to the cellular growth and death of MCL In addition the role of maintenance therapy and timing of administration in MCL will be assessed
Treatment Patients in this study will receive bortezomib and rituximab Both drugs will be administered through intravenous infusions There are two treatment periods in this study The first is considered induction therapy where patients will receive bortezomib and rituximab intermittently over an eighteen week period Lower dosages of rituximab will be given to patients at the beginning of the study to ensure no severe toxicity occurs Those patients without disease growth after the eighteen weeks of treatments will continue with maintenance therapy During this time period patients will be given bortezomib and rituximab for up to one year and a half Several tests and exams will be conducted throughout the study to closely monitor patients Treatments will be discontinued due to disease growth or unacceptable side effects
Purpose This study will evaluate the safety and efficacy of bortezomib and rituximab in patients with relapsed or refractory MCL Blood molecular and tumor analysis will be conducted to provide researchers with information about areas such as rituximab resistance the effects of bortezomib on cells associated with immune function and protein alterations related to the cellular growth and death of MCL In addition the role of maintenance therapy and timing of administration in MCL will be assessed
Treatment Patients in this study will receive bortezomib and rituximab Both drugs will be administered through intravenous infusions There are two treatment periods in this study The first is considered induction therapy where patients will receive bortezomib and rituximab intermittently over an eighteen week period Lower dosages of rituximab will be given to patients at the beginning of the study to ensure no severe toxicity occurs Those patients without disease growth after the eighteen weeks of treatments will continue with maintenance therapy During this time period patients will be given bortezomib and rituximab for up to one year and a half Several tests and exams will be conducted throughout the study to closely monitor patients Treatments will be discontinued due to disease growth or unacceptable side effects
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 |
|---|---|---|---|
| NCI-2011-03233 | REGISTRY | CTRP Clinical Trial Reporting Program | None |