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
- 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)
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety and toxicity of vaccination with lethally irradiated autologous CLL cells admixed with GM-562 cells following reduced intensity allogeneic stem cell transplant for CLL patients with advanced disease.
Catherine J. Wu, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|