Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination
1 other identifier
interventional
27
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2007
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedSeptember 17, 2020
September 1, 2020
7 years
February 27, 2007
September 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 years
Secondary Outcomes (2)
To characterize the biologic activity in response to vaccination with lethally irradiated autologous CLL cells admixed with GM-562 cells, following reduced intensity allogeneic stem cell transplant
2 years
to estimate duration of disease response, disease free and overall survival.
2 years
Study Arms (1)
GM-K562 Vaccine
EXPERIMENTALBiological/Vaccine: GM-K562 vaccine The vaccine will be administered over 1 cycle of 7 weeks, that begins 1 month after stem cell transplant. The vaccine will be given 6 times over 2 months -- once a week for three weeks then every other week for 3 vaccines. Procedure/Surgery: stem cell transplantation Participants will be admitted to the hospital for approximately 8 days to receive chemotherapy and stem cell transplantation
Interventions
The vaccine will be administered over 1 cycle of 7 weeks, that begins 1 month after stem cell transplant. The vaccine will be given 6 times over 2 months -- once a week for three weeks then every other week for 3 vaccines.
Participants will be admitted to the hospital for approximately 8 days to receive chemotherapy and stem cell transplantation
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (1)
Burkhardt UE, Hainz U, Stevenson K, Goldstein NR, Pasek M, Naito M, Wu D, Ho VT, Alonso A, Hammond NN, Wong J, Sievers QL, Brusic A, McDonough SM, Zeng W, Perrin A, Brown JR, Canning CM, Koreth J, Cutler C, Armand P, Neuberg D, Lee JS, Antin JH, Mulligan RC, Sasada T, Ritz J, Soiffer RJ, Dranoff G, Alyea EP, Wu CJ. Autologous CLL cell vaccination early after transplant induces leukemia-specific T cells. J Clin Invest. 2013 Sep;123(9):3756-65. doi: 10.1172/JCI69098. Epub 2013 Aug 5.
PMID: 23912587DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine J. Wu, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 27, 2007
First Posted
March 1, 2007
Study Start
February 1, 2007
Primary Completion
February 1, 2014
Study Completion
April 1, 2020
Last Updated
September 17, 2020
Record last verified: 2020-09