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

This study is ongoing, but not recruiting participants.
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: July 25, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Lymphoma, Mantle-Cell
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
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1-2 Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous "Immunotransplant" for Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 57
Study Start Date: August 2009
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490529

Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Ronald Levy
National Institutes of Health (NIH)
Investigators
Principal Investigator: Ronald Levy Stanford University
  More Information

Publications:
Responsible Party: Ronald Levy, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00490529     History of Changes
Other Study ID Numbers: LYMNHL0040-BMT212  LYMNHL0040-BMT212  IRB-05089  96940 
Study First Received: June 20, 2007
Last Updated: July 25, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Vaccines
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 30, 2016