Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma

PFS is time from on study date until disease relapse or progression, death, or date of last follow-up. Progression was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma and is defined as ≥50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously involved node or the appearance of any new lesion.

Time frame: From participants on study date until date of disease relapse or progression, death, or date of last follow-up, assessed up to 245.8 months

Participants with an immune response to idiotype vaccine measured by enzyme-linked immunosorbent assay (ELISA) to detect antibody binding to tumor cells. Positive response was defined as at least a fourfold increase in antibody titer.

Time frame: Weeks 12 to 32

Population: 23/26 participants were analyzed because vaccine was unable to be produced in two participants and one participant progressed prior to receiving the last vaccine dose.

OS was determined by the Kaplan-Meier method and is defined as the time from treatment start date until date of death or last follow-up.

Time frame: Time from treatment start date until date of death or date last follow-up, up to 250 months

Response was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma. Complete Response (CR) is a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., Lactate dehydrogenase (LDH) definitely assignable to the lymphoma. Complete Response Unconfirmed (CRu) is as per CR criteria except that if a residual node is \> 1.5cm, it must have regressed by \> 75% in the sum of the products of the greatest diameters (SPD). Partial Response (PR) is ≥50% decreased in the SPD of 6 largest dominant nodes or nodal masses. Stable Disease (SD) is defined as less than a PR but not progressive disease. Progression is ≥50% increase from nadir in the SPD of any previously involved node or the appearance of any new lesion.

Time frame: After 6 cycles of EPOCH-R therapy, an average of 18 weeks

Participants with an immune response against carrier molecule KLH measured by enzyme-linked immunosorbent assay (ELISA) to detect antibody binding to tumor cells. Positive response was defined as at least a fourfold increase in antibody titer.

Time frame: After vaccinations administered at 0, 1, 2, 3 and 5 months

Population: 23/26 participants were analyzed because vaccine was unable to be produced in two participants and one participant progressed prior to receiving the last vaccine.

Serious and/or non-serious adverse events were assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.

Time frame: Up to 30 days after last intervention, up to 12.5 months or 1.04 years

Participants with tumor specific T-cell responses during B-cell recovery was assessed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab and were measured by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT). A positive response required the response to be at least twice the negative controls.

Time frame: After vaccinations administered at 0, 1, 2, 3 and 5 months

Population: 23/26 participants were analyzed because vaccine was unable to be produced in two participants and one participant progressed prior to receiving the last vaccine.

PFS is defined as the time from start of treatment until disease relapse or progression, death, or last follow-up. Progression was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma and is defined as ≥50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously involved node or the appearance of any new lesion

Time frame: Time from treatment start date until date of disease relapse or progression, death, or date last follow-up, an average of 25 months

Population: 23/26 participants were analyzed because vaccine was unable to be produced in two participants and one participant progressed prior to receiving the last vaccine.

Recovery of CD4+ was measured by flow cytometry. Blood samples were collected via apheresis and analyzed by multicolor flow cytometry in peripheral blood mononuclear cells (PBMCs) for cluster of differentiation 4 (CD4). Time to recovery of CD4 T lymphocytes was defined as the time required for CD4 T lymphocytes to increase above the lower limit of normal of the normal laboratory value range of 359 cells/mcL

Time frame: After chemotherapy before vaccination, up to 6 months

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Time frame: Up to 30 days after last intervention, up to 12.5 months or 1.04 years