Trial Outcomes & Findings for Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma (NCT NCT00005780)
NCT ID: NCT00005780
Last Updated: 2023-01-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
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
Results posted on
2023-01-31
Participant Flow
Participant milestones
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
|---|---|
|
EPOCH-R Administration
STARTED
|
26
|
|
EPOCH-R Administration
COMPLETED
|
26
|
|
EPOCH-R Administration
NOT COMPLETED
|
0
|
|
Vaccine Administration Following EPOCH-R
STARTED
|
24
|
|
Vaccine Administration Following EPOCH-R
COMPLETED
|
23
|
|
Vaccine Administration Following EPOCH-R
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
|---|---|
|
Vaccine Administration Following EPOCH-R
Participant progressed before receiving the last vaccine.
|
1
|
Baseline Characteristics
Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=26 Participants
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
|
Mantle Cell Lymphoma International Prognostic Index (MIPI)
Low
|
16 Participants
n=5 Participants
|
|
Mantle Cell Lymphoma International Prognostic Index (MIPI)
Intermediate
|
7 Participants
n=5 Participants
|
|
Mantle Cell Lymphoma International Prognostic Index (MIPI)
High
|
3 Participants
n=5 Participants
|
|
Performance Status
|
1 score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: From participants on study date until date of disease relapse or progression, death, or date of last follow-up, assessed up to 245.8 monthsPFS 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.
Outcome measures
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=26 Participants
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
Grade 4
Grade 4 is life-threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Median Progression-free Survival (PFS) in Participants Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R)
|
23.5 Months
Interval 8.8 to 245.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Weeks 12 to 32Population: 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.
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.
Outcome measures
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=23 Participants
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
Grade 4
Grade 4 is life-threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Percentage of Participants With an Antibody Response to Idiotype Vaccine
|
30 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: After 6 cycles of EPOCH-R therapy, an average of 18 weeksResponse 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.
Outcome measures
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=26 Participants
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
Grade 4
Grade 4 is life-threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R)
Progression
|
3.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R)
Complete Response
|
80.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R)
Complete Response Unconfirmed
|
7.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R)
Partial Response
|
7.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R)
Stable Disease
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after last intervention, up to 12.5 months or 1.04 yearsSerious 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.
Outcome measures
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=26 Participants
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
Grade 4
n=26 Participants
Grade 4 is life-threatening.
|
Grade 5
n=26 Participants
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Leukopenia
|
0 percentage of participants
|
84.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Thrombocytopenia
|
50 percentage of participants
|
7.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Thrombosis
|
15.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Infusion related reaction
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Serum glutamic oxaloacetic transaminase (SGOT) elevation
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Serum glutamic pyruvic transaminase (SGPT) elevation
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Infection
|
15.4 percentage of participants
|
3.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Hypomagnesemia
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Cerebrovascular ischemia
|
0 percentage of participants
|
3.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Motor neuropathy
|
11.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Back pain
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Dyspnea
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Erectile dysfunction
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Allergic reaction
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Anemia
|
69.2 percentage of participants
|
3.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Febrile neutropenia
|
42.3 percentage of participants
|
3.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Lymphopenia
|
38.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Neutropenia
|
0 percentage of participants
|
88.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Hyperglycemia
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
Sensory neuropathy
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Time from treatment start date until date of death or date last follow-up, up to 250 monthsOS 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.
Outcome measures
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=26 Participants
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
Grade 4
Grade 4 is life-threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Overall Survival (OS)
|
89.7 Months
Interval 32.4 to 245.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from treatment start date until date of disease relapse or progression, death, or date last follow-up, an average of 25 monthsPopulation: 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
Outcome measures
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=23 Participants
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
Grade 4
Grade 4 is life-threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Progression Free Survival (PFS) in Participants Who Received Idiotype Vaccine
|
25.0 Months
Interval 8.8 to 245.8
|
—
|
—
|
SECONDARY outcome
Timeframe: After vaccinations administered at 0, 1, 2, 3 and 5 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=23 Participants
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
Grade 4
Grade 4 is life-threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Percentage of Participants With Antibodies to Keyhole Limpet Haemocyanin (KLH)
|
74 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: After vaccinations administered at 0, 1, 2, 3 and 5 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=23 Participants
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
Grade 4
Grade 4 is life-threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Percentage of Participants With Induction of Type 1 Cytokine T-cell Response
Peripheral blood mononuclear cells (PBMC)
|
87 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Induction of Type 1 Cytokine T-cell Response
Granulocyte macrophage colony-stimulating factor (GM-CSF)
|
65 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Induction of Type 1 Cytokine T-cell Response
Tumor necrosis factor α (TNFα)
|
52 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Induction of Type 1 Cytokine T-cell Response
Interferon-gamma (IFN-γ)
|
74 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: After chemotherapy before vaccination, up to 6 monthsRecovery 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
Outcome measures
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=23 Participants
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
Grade 4
Grade 4 is life-threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Time to Recovery of CD4 T Lymphocytes (CD4+)
|
3 Months
Interval 2.8 to 5.4
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days after last intervention, up to 12.5 months or 1.04 yearsHere 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.
Outcome measures
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=26 Participants
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
Grade 4
Grade 4 is life-threatening.
|
Grade 5
Grade 5 is death related to adverse event.
|
|---|---|---|---|
|
Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0).
|
26 Participants
|
—
|
—
|
Adverse Events
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
Serious events: 14 serious events
Other events: 26 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=26 participants at risk
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Infections and infestations
Febrile neutropenia
|
38.5%
10/26 • Number of events 10 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Infections and infestations
Infection
|
7.7%
2/26 • Number of events 2 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
General disorders
Infusion related reaction
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
Other adverse events
| Measure |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab
n=26 participants at risk
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF).
EPOCH-R: EPOCH-R for 6 cycles
GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses
Idiotype vaccine: 1 injection of vaccine monthly for 5 doses
|
|---|---|
|
General disorders
Death unrelated to research and related to disease progression
|
65.4%
17/26 • Number of events 17 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.1%
6/26 • Number of events 6 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Hepatobiliary disorders
Alkaline phosphatase elevation
|
26.9%
7/26 • Number of events 7 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Immune system disorders
Allergic reaction
|
7.7%
2/26 • Number of events 2 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
80.8%
21/26 • Number of events 21 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Anemia
|
92.3%
24/26 • Number of events 24 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Gastrointestinal disorders
Anorexia
|
53.8%
14/26 • Number of events 14 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Psychiatric disorders
Anxiety
|
38.5%
10/26 • Number of events 10 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
76.9%
20/26 • Number of events 20 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • Number of events 2 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Hepatobiliary disorders
Bilirubin elevation
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Eye disorders
Blurred vision
|
15.4%
4/26 • Number of events 4 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
88.5%
23/26 • Number of events 23 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Cardiac disorders
Cerebrovascular ischemia
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Nervous system disorders
Confusion
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Gastrointestinal disorders
Constipation
|
96.2%
25/26 • Number of events 25 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
46.2%
12/26 • Number of events 12 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
CPK elevation
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Renal and urinary disorders
Creatinine elevation
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Reproductive system and breast disorders
Decreased libido
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Nervous system disorders
Depression
|
26.9%
7/26 • Number of events 7 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
73.1%
19/26 • Number of events 19 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Nervous system disorders
Dizziness
|
15.4%
4/26 • Number of events 4 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
38.5%
10/26 • Number of events 10 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Renal and urinary disorders
Dysuria
|
7.7%
2/26 • Number of events 2 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Cardiac disorders
Edema
|
26.9%
7/26 • Number of events 7 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
7.7%
2/26 • Number of events 2 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Nervous system disorders
Euphoria
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
General disorders
Fatigue
|
96.2%
25/26 • Number of events 25 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Infections and infestations
Febrile neutropenia
|
46.2%
12/26 • Number of events 12 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
General disorders
Fever
|
19.2%
5/26 • Number of events 5 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Eye disorders
Floaters
|
7.7%
2/26 • Number of events 2 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Endocrine disorders
Gynecomastia
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Nervous system disorders
Headache
|
38.5%
10/26 • Number of events 10 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Gastrointestinal disorders
Hematochezia
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.7%
2/26 • Number of events 2 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Endocrine disorders
Hot flashes
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.3%
11/26 • Number of events 11 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Cardiac disorders
Hypertension
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.4%
4/26 • Number of events 4 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.5%
3/26 • Number of events 3 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.4%
4/26 • Number of events 4 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Endocrine disorders
Hypothyroid
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Infections and infestations
Infection
|
23.1%
6/26 • Number of events 6 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
General disorders
Infusion related reaction
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Nervous system disorders
Insomnia
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
General disorders
Leg pain
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Leukopenia
|
84.6%
22/26 • Number of events 22 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
13/26 • Number of events 13 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Nervous system disorders
Motor neuropathy
|
19.2%
5/26 • Number of events 5 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
7.7%
2/26 • Number of events 2 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
38.5%
10/26 • Number of events 10 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
53.8%
14/26 • Number of events 14 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Gastrointestinal disorders
Nausea
|
53.8%
14/26 • Number of events 14 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Neutropenia
|
88.5%
23/26 • Number of events 23 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Cardiac disorders
Phlebitis
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
11.5%
3/26 • Number of events 3 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
PT elevation
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
PTT elevation
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.1%
6/26 • Number of events 6 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Nervous system disorders
Sensory neuropathy
|
96.2%
25/26 • Number of events 25 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Hepatobiliary disorders
SGOT elevation
|
19.2%
5/26 • Number of events 5 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Hepatobiliary disorders
SGPT elevation
|
19.2%
5/26 • Number of events 5 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Gastrointestinal disorders
Stomatitis
|
92.3%
24/26 • Number of events 24 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Gastrointestinal disorders
Taste disturbance
|
65.4%
17/26 • Number of events 17 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Eye disorders
Tearing
|
15.4%
4/26 • Number of events 4 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
84.6%
22/26 • Number of events 22 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Cardiac disorders
Thrombosis
|
15.4%
4/26 • Number of events 4 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.7%
2/26 • Number of events 2 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Eye disorders
Visual loss
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Gastrointestinal disorders
Vomiting
|
26.9%
7/26 • Number of events 7 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
General disorders
Weight loss
|
23.1%
6/26 • Number of events 6 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
3.8%
1/26 • Number of events 1 • Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place