Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL
This trial is active, not recruiting.
|Treatments||cpg-mcl vaccine, primed t-cells, autologous peripheral blood stem cell transplantation, ct scan, pet-ct scan, pf-3512676, rituximab|
|Collaborator||National Institutes of Health (NIH)|
|Start date||August 2009|
|End date||September 2017|
|Trial size||57 participants|
|Trial identifier||NCT00490529, 96940, IRB-05089, LYMNHL0040-BMT212|
Mantle Cell Lymphoma is a sub-type of Non-Hodgkin's Lymphoma which is generally considered incurable with current therapy. Our goal is to accrue 59 patients who receive an autologous vaccine against their individual lymphoma after undergoing stem cell transplantation. Our hope is that vaccination will prolong the time which patients will stay in remission from their disease.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
The primary endpoint of the trial is freedom from molecular residual disease (MRD) at the landmark of one-year post-transplant.
time frame: Samples for MRD analysis are collected every 3 months until one-year post transplant.
Secondary objectives are Time To Clinical Progression (TTP), and evaluation of anti-tumor immune responses after vaccination, and after immunotransplant. progression-free survival.
time frame: 1 year, 3 years, 5 years
Male or female participants from 21 years up to 70 years old.
Inclusion Criteria (at time of enrollment): - Patients must be newly diagnosed with mantle cell lymphoma, have an accessible disease site for excisional biopsy or have sufficient peripheral blood tumor to leukapherese at least 1.5 x 109 lymphoma cells in a single session. - By standard clinical criteria, be medically appropriate to receive rituximab and standard induction chemotherapy and high-dose chemotherapy with AHCT. - Patients must be HIV negative. - ECOG performance status 0, 1, or 2 or Karnofsky performance scale 50-100%. - Patients must be capable of signing an informed consent. Exclusion Criteria: - Patients who are currently taking immunosuppressive medications. - Patients with severe psychological or medical illness. - Pregnant or lactating women. - At the discretion of the principal investigator if he/she feels that the patient is unable to safely complete the study. Specifically, patients must be considered medically eligible to undergo standard high dose chemotherapy and autologous stem cell transplantation.
|Official title||Phase 1-2 Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous "Immunotransplant" for Mantle Cell Lymphoma|
|Principal investigator||Ronald Levy|
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