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Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL
Not Recruiting
Trial ID: NCT00490529
Purpose
Mantle cell lymphoma (MCL) is a sub-type of non-Hodgkin's lymphoma (NHL) which is generally
considered incurable with current therapy. Participants will receive an autologous vaccine
against their individual lymphoma after undergoing stem cell transplantation. This
vaccination may prolong the time which patients will stay in remission from their disease.
Official Title
Phase 1-2 Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous "Immunotransplant" for Mantle Cell Lymphoma
Stanford Investigator(s)
Robert Negrin
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Wen-Kai Weng, MD, PhD
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Ash A. Alizadeh, MD/PhD
Moghadam Family Professor
Sally Arai
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Michael Khodadoust
Assistant Professor of Medicine (Oncology) and of Dermatology
Eligibility
INCLUSION CRITERIA
- Newly-diagnosed with mantle cell lymphoma (MCL) with accessible disease site for
excisional biopsy, OR have sufficient peripheral blood tumor to leukapherese ≥ 1.5 x
10e9 lymphoma cells in a single session
- Medically appropriate by standard clinical criteria to receive rituximab and standard
induction chemotherapy and high-dose chemotherapy with autologous hematopoietic cell
transplant (AHCT)
- HIV-negative
- Eastern Cooperative Oncology Group (ECOG) Performance Status, OR Karnofsky performance
scale 50 to 100%
- Capable of providing informed consent
EXCLUSION CRITERIA
- Currently receiving immunosuppressive medications
- Severe psychological or medical illness
- Pregnant or lactating
- Unable to safely complete the study, at the discretion of the principal investigator
Intervention(s):
drug: Rituximab
biological: CpG-MCL vaccine
procedure: Vaccine-primed T-cells
biological: PF-3512676
procedure: Autologous hematopoietic stem cell transplant (HSCT)
drug: Standard induction chemotherapy
drug: Cyclophosphamide
drug: Filgrastim
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061