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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Stanford University
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Ronald Levy, Stanford University
ClinicalTrials.gov Identifier:
NCT00490529
First received: June 20, 2007
Last updated: April 12, 2016
Last verified: April 2016

June 20, 2007
April 12, 2016
August 2009
September 2017   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
After the one-year mark, samples for MRD analysis will be collected every 6 months for 3 years or until disease progression.
Progression free survival [ Time Frame: 3 years ]
Complete list of historical versions of study NCT00490529 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Evaluate immune responses and quantitative assessment of molecular residual disease [ Time Frame: 3 years ]
Not Provided
Not Provided
 
Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL
Phase 1-2 Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous "Immunotransplant" for Mantle Cell Lymphoma
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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, Mantle-Cell
  • Biological: CpG-MCL vaccine, primed T-cells
    Other Name: CpG-activated, autologous tumor vaccine
  • Procedure: Autologous peripheral blood stem cell transplantation
    Standard of Care
    Other Name: Hematopoietic stem cell transplantation
  • Procedure: CT scan
    Standard of Care
    Other Name: X-ray computed tomography
  • Procedure: PET-CT scan
    Standard of Care
    Other Name: Poset emission tomography
  • Drug: PF-3512676
    18 mg subcutaneous injection
    Other Name: Pfizer
  • Drug: Rituximab
    375 mg/m2 iv Standard of care.
    Other Names:
    • Rituxan
    • MabThera
Experimental: "CpG-MCL" vaccine
Patients will initially receive three 'priming' CpG-MCL vaccinations in 21 days at 4-7 day intervals, followed by collection of "primed" T-Cells. Subsequently, within 72 hours of autologous hematopoetic cell transplant (AHCT)(standard of care procedure), the patient will receive his/her CpG-MCL vaccine and reinfusion of primed T cells ("immunotransplant"). At >/= 3 months after AHCT, when medically feasible, the patient will receive the final CpG-MCL vaccine. Regular follow-up research analysis of molecular residual disease will continue for 3 years or until disease progression.
Interventions:
  • Biological: CpG-MCL vaccine, primed T-cells
  • Procedure: Autologous peripheral blood stem cell transplantation
  • Procedure: CT scan
  • Procedure: PET-CT scan
  • Drug: PF-3512676
  • Drug: Rituximab
Brody JD, Goldstein MJ, Czerwinski DK, Levy R. Immunotransplantation preferentially expands T-effector cells over T-regulatory cells and cures large lymphoma tumors. Blood. 2009 Jan 1;113(1):85-94. doi: 10.1182/blood-2008-05-155457. Epub 2008 Sep 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
59
September 2020
September 2017   (final data collection date for primary outcome measure)

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.
Both
21 Years to 70 Years
No
United States
 
NCT00490529
LYMNHL0040-BMT212, LYMNHL0040-BMT212, IRB-05089, 96940
Yes
Not Provided
Not Provided
Ronald Levy, Stanford University
Ronald Levy
National Institutes of Health (NIH)
Principal Investigator: Ronald Levy Stanford University
Stanford University
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP