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

Completed · Phase 2

Conditions studied: Lymphoma, Mantle-Cell

In brief

Mantle cell lymphoma (MCL) is a sub-type of non-Hodgkin's lymphoma (NHL) which is generally considered incurable with current therapy. Participants will receive an autologous vaccine against their individual lymphoma after undergoing stem cell transplantation. This vaccination may prolong the time which patients will stay in remission from their disease.

Key facts

Study ID

NCT00490529

Run by

Ronald Levy

People needed

59

Starts

2009-08-01

Expected to finish

2017-12-14

Last updated by the study team

2020-01-13

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly-diagnosed with mantle cell lymphoma (MCL) with accessible disease site for excisional biopsy, OR have sufficient peripheral blood tumor to leukapherese ≥ 1.5 x 10e9 lymphoma cells in a single session
• Medically appropriate by standard clinical criteria to receive rituximab and standard induction chemotherapy and high-dose chemotherapy with autologous hematopoietic cell transplant (AHCT)
• HIV-negative
• Eastern Cooperative Oncology Group (ECOG) Performance Status, OR Karnofsky performance scale 50 to 100%
• Capable of providing informed consent

You may not qualify if…

• Currently receiving immunosuppressive medications
• Severe psychological or medical illness
• Pregnant or lactating
• Unable to safely complete the study, at the discretion of the principal investigator

Where it is running

• Stanford University Medical Center — Stanford, California, United States

Full record on ClinicalTrials.gov

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