Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL

Not Recruiting

Trial ID: NCT00490529

Age - 21 Years-70 Years Condition - Blood and Marrow Transplant (BMT), Lymphomas: Non-Hodgkin, Mantle Cell Lymphoma Gender - All Accepting Healthy Volunteers - No

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)

Michael Khodadoust
Michael Khodadoust

Assistant Professor of Medicine (Oncology) and of Dermatology

Wen-Kai Weng, MD, PhD
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
Ash A. Alizadeh, MD/PhD

Moghadam Family Professor

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology

Sandra Horning

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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

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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

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