Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00383994
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2006-10-02
Brief Title:
Immunotherapy With NK Cell Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Immunotherapy With NK Cell Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2019-07
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:
The goal of this clinical research study is to find out if giving a boost of natural killer NK cells from a donor combined with Rituxan rituximab can help to control disease in patients who have already received an allogeneic stem cell transplant The safety of this treatment will also be studied Participants have recurrent chronic lymphocytic leukemia CLL or lymphoma after non-myeloablative stem cell transplantation
Primary Objectives
10 To determine the safety of Natural Killer NK cells and Rituximab rhu-Granulocyte-macrophage colony-stimulating factor GMCSF in patients with persistent or recurrent B-cell lymphoid malignancies after non-myeloablative stem cell transplantation
20 To determine factors associated with response
Primary Objectives
10 To determine the safety of Natural Killer NK cells and Rituximab rhu-Granulocyte-macrophage colony-stimulating factor GMCSF in patients with persistent or recurrent B-cell lymphoid malignancies after non-myeloablative stem cell transplantation
20 To determine factors associated with response
Detailed Description:
Rituximab is designed to attach to lymphoma cells causing them to die GM-CSF and NK cells may increase rituximabs ability to kill these cells
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 your complete medical history recorded and a physical exam Your blood about 2 tablespoons will be collected for routine tests A bone marrow aspirate will be performed To collect a bone marrow aspirate an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle You will have computerized tomography CT scans as well as positron emission tomography PET or gallium scans to learn the status of your disease Women who are able to have children must have a negative blood or urine pregnancy test
If you are found eligible to take part in this study you will receive treatment as an outpatient You will receive GM-CSF 3 times a week for 4 weeks through a vein starting the day before you receive the administration of rituximab You will receive rituximab over 4 to 8 hours through a vein once weekly for 4 weeks You will also get a boost of NK cells from the same donor from whom you received your original transplant These cells will be infused through a vein over 30 to 60 minutes after the 4th dose of rituximab If you are receiving a cell infusion from somebody who you are not related to the infusion may have to be done later if cells were not available as scheduled
The CliniMACS System is a medical device that is used to separate types of blood cells from blood that is removed from the body during leukapheresis These separated cells are processed for use in treatments such as stem cell transplants
During this treatment you will be examined as needed and blood samples 1 tablespoon once or twice a week will be taken for routine tests You may need to receive blood transfusions during this study if your blood cell counts remain low
You may be taken off this study if your disease gets worse or intolerable side effects occur
You will have long-term follow-up visits while on study You will be seen at 4 to 6 weeks after you receive NK cell infusion every 3 months during the first year and then once a year During each of these visits you will have CT and PET scans a bone marrow biopsy and blood drawn about 4 teaspoons to learn the status of your disease
This is an investigational study Rituximab and GM-CSF are FDA approved and commercially available NK cells are authorized by the FDA for use in research only Up to 40 participants will take part in this study All will be enrolled at the University of Texas UT MD Anderson Cancer Center
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 your complete medical history recorded and a physical exam Your blood about 2 tablespoons will be collected for routine tests A bone marrow aspirate will be performed To collect a bone marrow aspirate an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle You will have computerized tomography CT scans as well as positron emission tomography PET or gallium scans to learn the status of your disease Women who are able to have children must have a negative blood or urine pregnancy test
If you are found eligible to take part in this study you will receive treatment as an outpatient You will receive GM-CSF 3 times a week for 4 weeks through a vein starting the day before you receive the administration of rituximab You will receive rituximab over 4 to 8 hours through a vein once weekly for 4 weeks You will also get a boost of NK cells from the same donor from whom you received your original transplant These cells will be infused through a vein over 30 to 60 minutes after the 4th dose of rituximab If you are receiving a cell infusion from somebody who you are not related to the infusion may have to be done later if cells were not available as scheduled
The CliniMACS System is a medical device that is used to separate types of blood cells from blood that is removed from the body during leukapheresis These separated cells are processed for use in treatments such as stem cell transplants
During this treatment you will be examined as needed and blood samples 1 tablespoon once or twice a week will be taken for routine tests You may need to receive blood transfusions during this study if your blood cell counts remain low
You may be taken off this study if your disease gets worse or intolerable side effects occur
You will have long-term follow-up visits while on study You will be seen at 4 to 6 weeks after you receive NK cell infusion every 3 months during the first year and then once a year During each of these visits you will have CT and PET scans a bone marrow biopsy and blood drawn about 4 teaspoons to learn the status of your disease
This is an investigational study Rituximab and GM-CSF are FDA approved and commercially available NK cells are authorized by the FDA for use in research only Up to 40 participants will take part in this study All will be enrolled at the University of Texas UT MD Anderson Cancer Center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-2012-01375 | REGISTRY | NCI CTRP | None |