Phase I/II of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL
Conditions
Lymphoma, Mantle-Cell
Conditions: official terms
Lymphoma, Mantle-Cell
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CpG-MCL vaccine, primed T-cells Type: Biological
Name: Autologous peripheral blood stem cell transplantation Type: Procedure
Name: CT scan Type: Procedure
Name: PET-CT scan Type: Procedure
Name: PF-3512676 Type: Drug
Name: Rituximab Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients must be newly diagnosed with MCL, have an accessible disease site for excisional biopsy or sufficient peripheral blood tumor burden to safely leukapherese.

- By standard clinical criteria be medically appropriate to receive induction chemotherapy and high-dose chemotherapy with AHCT.

- Must be between 18 to 70 years of age.

- Serum creatinine <2.0 or 24-hour creatinine clearance >60 ml/min.

- Patients must be HIV negative.

- ECOG performance status 0, 1, or 2.

- Patients must be capable of signing an informed consent.

Exclusion Criteria:

- Patients who are currently taking immunosuppressive medications.

- Severe psychological or medical illness.

- Patients may not be receiving any other investigational agents.

- Pregnant or lactating women.
Location
Stanford University Medical Center
Stanford, California, United States
Status: Recruiting
Contact: Ami Okada - 650-725-4968 - amio@stanford.edu
Start Date
August 2009
Completion Date
September 2020
Sponsors
Ronald Levy
Source
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page