Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442130
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2007-02-27
Brief Title:
Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Reduced Intensity Stem Cell Transplantation for Advanced Chronic Lymphocytic Leukemia Followed by Vaccination With Lethally Irradiated Autologous Tumor Cells Admixed With Granulocyte Macrophage-colony Stimulating Factor Secreting K562 Cells
Status:
COMPLETED
Status Verified Date:
2020-09
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 purpose of this research study is to assess the safety and immune activity of a vaccine made from the participants own cancer cells when administered after a reduced intensity transplant In recent years researchers at Dana-Farber Cancer Institute have discovered that vaccines made from a patientss own cancer cells that have been engineered in the laboratory to produce a protein called GM-CSF can be effective in stimulating a powerful immune response specific to that cancer
Detailed Description:
This study can be divided into four phases 1 Screening 2 Reduced intensity transplant phase 3 Vaccinations cycle 1 and cycle 2each cycle lasts 7 weeks and 4 Vaccine completion
Screening Phase After signing the consent form participants will be asked to undergo some screening tests and procedures to find out if they are eligible to participate in the study These tests and procedures are likely to be part of regular cancer care and may be done even if the patient does not take part in the research study It is important to note that if insufficient numbers of the participants leukemia cells to generate vaccine were collected on the CLL collection and banking study DFHCC study 06-200 then they will not be eligible to participate in this study
Allogeneic reduced intensity stem cell transplant phase The transplant phase of the study will begin when the participant is admitted to the hospital to receive chemotherapy and stem cell transplant The minimum duration of hospitalization for the procedure is approximately 8 days Undergoing transplant involves the following procedures and treatments Central intravenous catheter chemotherapy medications to prevent graft versus host disease GVHD medication to prevent infections physical exams blood tests and bone marrow biopsy and aspirate
Vaccination Phase Vaccinations will be given in two cycles of seven weeks each that are identical with the exception of when they are administered Cycle 1 vaccination will begin approximately one month after the stem cells have been infused provided there is no significant evidence of GVHD Cycle 2 vaccination will be being approximately one month after discontinuing tacrolimus provided there is no evidence of severe acute or chronic GVHD The vaccine will be given 6 times over a period of two months The participant will receive vaccination shots once weekly for 3 vaccines and then every other week for 3 vaccines
Skin biopsies will be done after the first and after the fifth vaccinations Current status of the participants CLL will be assessed to determine how the disease has responded to transplant and vaccination These tests include analysis of bone marrow and blood tests
Vaccine completion phase After one cycle of vaccination is completed the participant will return to the outpatient clinic monthly for check-ups for 6 visits to monitor the effects of the vaccine
Since this trial involves the use of genetically modified cells it is recommended that participants on this trial undergo annual checkups for at least 20 years in order to monitor for long term effects of the vaccination treatment
Screening Phase After signing the consent form participants will be asked to undergo some screening tests and procedures to find out if they are eligible to participate in the study These tests and procedures are likely to be part of regular cancer care and may be done even if the patient does not take part in the research study It is important to note that if insufficient numbers of the participants leukemia cells to generate vaccine were collected on the CLL collection and banking study DFHCC study 06-200 then they will not be eligible to participate in this study
Allogeneic reduced intensity stem cell transplant phase The transplant phase of the study will begin when the participant is admitted to the hospital to receive chemotherapy and stem cell transplant The minimum duration of hospitalization for the procedure is approximately 8 days Undergoing transplant involves the following procedures and treatments Central intravenous catheter chemotherapy medications to prevent graft versus host disease GVHD medication to prevent infections physical exams blood tests and bone marrow biopsy and aspirate
Vaccination Phase Vaccinations will be given in two cycles of seven weeks each that are identical with the exception of when they are administered Cycle 1 vaccination will begin approximately one month after the stem cells have been infused provided there is no significant evidence of GVHD Cycle 2 vaccination will be being approximately one month after discontinuing tacrolimus provided there is no evidence of severe acute or chronic GVHD The vaccine will be given 6 times over a period of two months The participant will receive vaccination shots once weekly for 3 vaccines and then every other week for 3 vaccines
Skin biopsies will be done after the first and after the fifth vaccinations Current status of the participants CLL will be assessed to determine how the disease has responded to transplant and vaccination These tests include analysis of bone marrow and blood tests
Vaccine completion phase After one cycle of vaccination is completed the participant will return to the outpatient clinic monthly for check-ups for 6 visits to monitor the effects of the vaccine
Since this trial involves the use of genetically modified cells it is recommended that participants on this trial undergo annual checkups for at least 20 years in order to monitor for long term effects of the vaccination treatment
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