Phase 2 N=59 Treatment

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

Lymphoma, Mantle-Cell

Bottom Line

View on ClinicalTrials.gov: NCT00490529 ↗

Enrolled (actual)

Serious AEs

64.6%

Results posted

Jan 2020

Primary outcome: Primary: Freedom From Molecular Residual Disease (MRD) Post-autologous Stem Cell Transplant (ASCT) — 41 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CpG-MCL vaccine (Biological); PF-3512676 (Biological); Vaccine-primed T-cells (Procedure); Autologous hematopoietic stem cell transplant (HSCT) (Procedure); Rituximab (Drug); Standard induction chemotherapy (Drug); Cyclophosphamide (Drug); Filgrastim (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Ronald Levy
Primary completion: Dec 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

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.