Phase 2
Completed N=59
Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL
Lymphoma, Mantle-Cell
Source: ClinicalTrials.gov NCT00490529 ↗
Enrolled (actual)
59
Serious AEs
64.6%
Results posted
Jan 2020
Primary outcomePrimary: Freedom From Molecular Residual Disease (MRD) Post-autologous Stem Cell Transplant (ASCT) — 41 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Molecular Residual Disease (MRD) Post-autologous Stem Cell Transplant (ASCT) |
41 | — |
| SECONDARY Time-to-progression (TTP) |
6.9 | — |
| SECONDARY Overall Survival (OS) |
42; 33; 27; 19; 13 | — |
| SECONDARY Detection of Tumor-specific CD8-positve Memory T-cells Before and After Vaccination |
31; 14 | — |
| SECONDARY Detection of Tumor-specific CD4-positve T-cells Before and After Vaccination |
20; 14 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00490529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.