Status:
COMPLETED
Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 rec...
Detailed Description
* 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00442130
Start Date
February 1 2007
End Date
April 1 2020
Last Update
September 17 2020
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115