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Phase I/II Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous "Immunotransplant" for Mantle Cell Lymphoma


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Lymphoma, Mantle-Cell

Thank you

Trial Information

Phase I/II Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous "Immunotransplant" for Mantle Cell Lymphoma


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint of the trial is freedom from molecular residual disease (MRD) at the landmark of one-year post-transplant.

Outcome Description:

After the one-year mark, samples for MRD analysis will be collected every 6 months for 3 years or until disease progression.

Outcome Time Frame:

Samples for MRD analysis are collected every 3 months until one-year post transplant.

Safety Issue:

No

Principal Investigator

Ronald Levy

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

LYMNHL0040

NCT ID:

NCT00490529

Start Date:

August 2009

Completion Date:

September 2020

Related Keywords:

  • Lymphoma, Mantle-cell
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location
Stanford University Medical Center Stanford, California  94305-5408