Overview

This trial is active, not recruiting.

Condition lymphoma, mantle-cell
Treatments cpg-mcl vaccine, primed t-cells, autologous peripheral blood stem cell transplantation, ct scan, pet-ct scan, pf-3512676, rituximab
Phase phase 2
Target CD20
Sponsor Ronald Levy
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
cpg-mcl vaccine, primed t-cells CpG-activated, autologous tumor vaccine
autologous peripheral blood stem cell transplantation Hematopoietic stem cell transplantation
Standard of Care
ct scan X-ray computed tomography
Standard of Care
pet-ct scan Poset emission tomography
Standard of Care
pf-3512676 Pfizer
18 mg subcutaneous injection
rituximab Rituxan
375 mg/m2 iv Standard of care.

Primary Outcomes

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.

Secondary Outcomes

Measure
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

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Stanford University.