Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00493454
Status:
TERMINATED
Last Update Posted:
2013-05-31
First Post:
2007-06-27
Brief Title:
Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20 Indolent Lymphomas
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Multicenter Phase II Study for Zevalin in Patients With RelapsedRefractory Indolent Lymphomas Extranodal Marginal Lymphoma of MALT Type Nodal Marginal Zone B-Cell Lymphoma and Splenic Marginal B-Cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
Overall Response Rate ORR
Secondary Objectives
The Duration of Response DR and Time to Treatment Progression TTP in all patients and in the responders
Complete Responses CRComplete Responses unconfirmed CRu and Partial Responses PR
Time to next anticancer therapy TTNT
Overall Response Rate ORR
Secondary Objectives
The Duration of Response DR and Time to Treatment Progression TTP in all patients and in the responders
Complete Responses CRComplete Responses unconfirmed CRu and Partial Responses PR
Time to next anticancer therapy TTNT
Detailed Description:
90 Y Ibritumomab tiuxetan and rituximab are both designed to attach to lymphoma cells causing them to die
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a physical exam Your blood about 2 to 3 teaspoons and urine will be collected for routine tests You will have a chest x-ray and computerized tomography CT scans of the neck chest abdomen and pelvis You will have a bone marrow aspirate and biopsy performed To collect a bone marrow aspirate and biopsy an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle Women who are able to have children must have a negative blood pregnancy test
The study doctors will first make sure that your disease has not spread too much and is not too severe to require immediate treatment with chemotherapy before you can begin treatment on this study If you are found to be eligible to take part in this study you will be given Benadryl diphenhydramine by vein and you will be given Tylenol acetaminophen by mouth before each dose of rituximab This is done to help decrease the risk of developing side effects of rituximab You will then receive 1 dose of rituximab by vein over 6 to 8 hours on Day 1 of treatment After treatment with rituximab you will then be given a radioactive antibody 111 In Ibritumomab tiuxetan this is a radioactive agent that binds to rituximab to help with imaging exams by vein over about 10 minutes This is so researchers can use a special camera to see where the drug is in your body
You will have imaging performed with the special camera on Day 1 and on either Day 2 or Day 3 On Day 8 you will receive a second dose of rituximab This will then be followed by a dose 90 Y Ibritumomab tiuxetan of given by vein over 10 minutes This completes the treatment
If you experience intolerable side effects while on this study you may be removed from this study The study doctor will then offer other treatment options to you
For your follow-up you will have blood about 2 tablespoons drawn once a week for the first 3 months then every 3 months for 1 year and then every 4 months for the second year At these visits you may also have CT scans x-rays and bone marrow biopsies and aspirates performed if needed
This is an investigational study 90 Y Ibritumomab tiuxetan and rituximab have been approved by the FDA for the treatment of indolent B-cell lymphoma Up to 35 patients will take part in this multicenter study Up to 15 will be enrolled at M D Anderson
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a physical exam Your blood about 2 to 3 teaspoons and urine will be collected for routine tests You will have a chest x-ray and computerized tomography CT scans of the neck chest abdomen and pelvis You will have a bone marrow aspirate and biopsy performed To collect a bone marrow aspirate and biopsy an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle Women who are able to have children must have a negative blood pregnancy test
The study doctors will first make sure that your disease has not spread too much and is not too severe to require immediate treatment with chemotherapy before you can begin treatment on this study If you are found to be eligible to take part in this study you will be given Benadryl diphenhydramine by vein and you will be given Tylenol acetaminophen by mouth before each dose of rituximab This is done to help decrease the risk of developing side effects of rituximab You will then receive 1 dose of rituximab by vein over 6 to 8 hours on Day 1 of treatment After treatment with rituximab you will then be given a radioactive antibody 111 In Ibritumomab tiuxetan this is a radioactive agent that binds to rituximab to help with imaging exams by vein over about 10 minutes This is so researchers can use a special camera to see where the drug is in your body
You will have imaging performed with the special camera on Day 1 and on either Day 2 or Day 3 On Day 8 you will receive a second dose of rituximab This will then be followed by a dose 90 Y Ibritumomab tiuxetan of given by vein over 10 minutes This completes the treatment
If you experience intolerable side effects while on this study you may be removed from this study The study doctor will then offer other treatment options to you
For your follow-up you will have blood about 2 tablespoons drawn once a week for the first 3 months then every 3 months for 1 year and then every 4 months for the second year At these visits you may also have CT scans x-rays and bone marrow biopsies and aspirates performed if needed
This is an investigational study 90 Y Ibritumomab tiuxetan and rituximab have been approved by the FDA for the treatment of indolent B-cell lymphoma Up to 35 patients will take part in this multicenter study Up to 15 will be enrolled at M D Anderson
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