Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/2/2019 |
| Start Date: | February 2007 |
| End Date: | July 2021 |
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
The purpose of this research study is to assess the safety and immune activity of a vaccine
made from the participant's 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 patients's 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.
made from the participant's 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 patients's 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.
- This study can be divided into four phases: 1) Screening; 2) Reduced intensity
transplant phase; 3) Vaccinations (cycle 1 and cycle 2:each 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 participant's leukemia cells to
generate vaccine were collected on the CLL collection and banking study (DF/HCC 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.
transplant phase; 3) Vaccinations (cycle 1 and cycle 2:each 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 participant's leukemia cells to
generate vaccine were collected on the CLL collection and banking study (DF/HCC 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.
Inclusion Criteria:
- Advanced CLL, defined as no response or progressive disease during standard nucleoside
analogue based regimen; or, evidence of progressive disease within 24 months of
completion of nucleoside analogue regimen; or, intolerance to fludarabine; or, failure
to achieve complete remission following salvage regimen.
- no sites of adenopathy > 5cm
- (8/8) HLA matched related or unrelated donor available.
- Must have prior banked tumor, collected by peripheral blood draw, leukapheresis, bone
marrow biopsy or by lymph node dissection, per DF/HCC protocol 06-200
- ECOG performance status 0-2
Exclusion Criteria:
- Serum creatinine greater than or equal to 2.0mg/dl
- ALT or AST greater than or equal to 3x ULN
- Total bilirubin greater than or equal to 2.0mg/dl (except for patients with Gilbert's
syndrome)
- Cardiac ejection fraction greater than or equal to 30%
- HIV infection
- Pregnancy
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