Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination
Completed · Phase 1
Conditions studied: Chronic Lymphocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT00442130
- Run by
- Dana-Farber Cancer Institute
- People needed
- 27
- Starts
- 2007-02-01
- Expected to finish
- 2020-04-01
- Last updated by the study team
- 2020-09-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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