Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination
Status: Recruiting
Phase: Phase 1
Diagnosis: Leukemia/MDS
NCT ID: NCT00442130
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 06-196
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.
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital
Overall PI:
Catherine Wu, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Ilene Galinsky, 617-632-3902,
igalinsky@partners.org
Eligibility Criteria
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 <30%
- HIV infection
- Pregnancy