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

Trial ID or NCT#

NCT00490529

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 21 to 70
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
    1. EXCLUSION CRITERIA
  2. * 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
Exclusion Criteria:
  1. * 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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Investigator(s)

Ronald Levy, MD
Ronald Levy, MD
Medical oncologist, Lymphoma specialist
Robert K. and Helen K. Summy Professor in the School of Medicine
Ash A. Alizadeh, MD/PhD
Ash A. Alizadeh, MD/PhD
Medical oncologist, Lymphoma specialist, Cancer geneticist
Moghadam Family Professor
Michael Khodadoust
Michael Khodadoust
Lymphoma specialist, Cutaneous oncology specialist, Hematologist, Hematologist-Oncologist
Assistant Professor of Medicine (Oncology) and of Dermatology

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov