Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 1/25/2018 |
| Start Date: | August 2009 |
| End Date: | December 14, 2017 |
Phase 1-2 Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous "Immunotransplant" for Mantle Cell Lymphoma
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.
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.
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.
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