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

Part of paid clinical trials in Stanford, California.

Sponsor
Ronald Levy
Study ID
NCT00490529
Phase
PHASE2
Status
Completed

Conditions

  • Lymphoma, Mantle-Cell

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CpG-MCL vaccine — BIOLOGICAL
    CpG-MCL vaccine is a vaccine prepared by co-culturing cells from the participant's mantle cell lymphoma suspension with 3 mcg/mL PF-3512676, then irradiated to 200 Gy. 1 x 10e8 CpG-MCL cells will be given as a subcutaneous injection.
  • PF-3512676 — BIOLOGICAL
    PF-03152676 is a synthetic immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) moledule containing unmethylated cytosine and guanine (CpG) motifs. PF-03512676 acts as an agonist of human Toll-like receptor 9, leading to activation of antigen-presenting cells and a cascade of antitumor immune reactions.
  • Vaccine-primed T-cells — PROCEDURE
    Vaccine primed T-cells are the post-vaccination leukapheresis harvest of peripheral blood mononuclear cells. Each collection is approx 1 x 10e10 CD3+ T-cells.
  • Autologous hematopoietic stem cell transplant (HSCT) — PROCEDURE
    Regular medical procedure
  • Rituximab — DRUG
    375 mg/m² by infusion
  • Standard induction chemotherapy — DRUG
    Patient-specific, regular medical care treatment as determined by treating oncologist
  • Cyclophosphamide — DRUG
    Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
  • Filgrastim — DRUG
    Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)

Study Details

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.

Key Dates

Start date
Aug 31, 2009
Status verified
Jan 2020
Primary completion
Dec 14, 2017
Completion
Dec 14, 2017

Study Design

Enrollment
59 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CpG-MCL Vaccine
    An autologous anti-tumor vaccine.

Primary Outcome Measure

Freedom From Molecular Residual Disease (MRD) Post-autologous Stem Cell Transplant (ASCT) [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterStanfordCalifornia94305-

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By research site
Stanford University Medical Center· Stanford, CA