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

Plain-language summary

This study looks at a CpG-activated whole cell vaccine followed by an immune transplant using the patient's own stem cells (autologous immunotransplant) in mantle cell lymphoma (MCL). Newly diagnosed patients with mantle cell lymphoma who were HIV-negative were able to take part. Sponsored by Ronald Levy, the study was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Ronald Levy

Intervention

CpG-MCL vaccine, PF-3512676, Vaccine-primed T-cells, Autologous hematopoietic stem cell transplant (HSCT), Rituximab, Standard induction chemotherapy, Cyclophosphamide, Filgrastim

Start date

8/1/2009

Estimated completion

12/14/2017

Countries

United States

Related genes

Locations

• Stanford, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

INCLUSION CRITERIA

* 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

EXCLUSION CRITERIA

* 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