Trial · NCT00005780
Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma
NCT00005780, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-01-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma. Trials, record NCT00005780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00005780
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma
- NCT number
- NCT00005780
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Mantle Cell Lymphoma, Lymphoma, Mantle Cell
- Interventions
- EPOCH-R, GM-CSF, Idiotype vaccine
- First posted
- 2000-06-05
- Last updated
- 2023-01-31
- Results first posted
- 2023-01-31
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression-free Survival (PFS) in Participants Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) | 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 | 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. |
| Primary | Percentage of Participants With an Antibody Response to Idiotype Vaccine | Weeks 12 to 32 | 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. |
| Secondary | Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) | After 6 cycles of EPOCH-R therapy, an average of 18 weeks | 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. |
| Secondary | 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 | Up to 30 days after last intervention, up to 12.5 months or 1.04 years | 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. |
| Secondary | Overall Survival (OS) | Time from treatment start date until date of death or date last follow-up, up to 250 months | 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. |
| Secondary | Progression Free Survival (PFS) in Participants Who Received Idiotype Vaccine | Time from treatment start date until date of disease relapse or progression, death, or date last follow-up, an average of 25 months | 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 |
| Secondary | Percentage of Participants With Antibodies to Keyhole Limpet Haemocyanin (KLH) | After vaccinations administered at 0, 1, 2, 3 and 5 months | 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. |
| Secondary | Percentage of Participants With Induction of Type 1 Cytokine T-cell Response | After vaccinations administered at 0, 1, 2, 3 and 5 months | 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. |
| Secondary | Time to Recovery of CD4 T Lymphocytes (CD4+) | After chemotherapy before vaccination, up to 6 months | 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 |
| Other | Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0). | Up to 30 days after last intervention, up to 12.5 months or 1.04 years | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Progression-free Survival (PFS) in Participants Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) | 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 | Months | MEDIAN | |
| PRIMARY | Percentage of Participants With an Antibody Response to Idiotype Vaccine | Weeks 12 to 32 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) | After 6 cycles of EPOCH-R therapy, an average of 18 weeks | percentage of participants | NUMBER | |
| SECONDARY | 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 | Up to 30 days after last intervention, up to 12.5 months or 1.04 years | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) | Time from treatment start date until date of death or date last follow-up, up to 250 months | Months | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) in Participants Who Received Idiotype Vaccine | Time from treatment start date until date of disease relapse or progression, death, or date last follow-up, an average of 25 months | 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. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Antibodies to Keyhole Limpet Haemocyanin (KLH) | After vaccinations administered at 0, 1, 2, 3 and 5 months | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Induction of Type 1 Cytokine T-cell Response | After vaccinations administered at 0, 1, 2, 3 and 5 months | 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. | percentage of participants | NUMBER |
| SECONDARY | Time to Recovery of CD4 T Lymphocytes (CD4+) | After chemotherapy before vaccination, up to 6 months | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0). | Up to 30 days after last intervention, up to 12.5 months or 1.04 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression-free Survival (PFS) in Participants Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 23.5 | Full Range 8.8 to 245.8 | Months | |
| Percentage of Participants With an Antibody Response to Idiotype Vaccine | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 30 | percentage of participants | ||
| Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 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) | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 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) | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 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) | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | Stable Disease | 0 | percentage of participants | |
| Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | Progression | 3.8 | 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 | Grade 3 | Allergic reaction | 3.8 | 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 | Grade 4 | Allergic reaction | 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 | Grade 5 | Allergic reaction | 0 | percentage of participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| EPOCH-R Administration | STARTED | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 26 | |
| EPOCH-R Administration | COMPLETED | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 26 | |
| EPOCH-R Administration | NOT COMPLETED | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 0 | |
| Vaccine Administration Following EPOCH-R | STARTED | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 24 | |
| Vaccine Administration Following EPOCH-R | COMPLETED | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 23 | |
| Vaccine Administration Following EPOCH-R | NOT COMPLETED | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 1 |
Source ClinicalTrials.gov
Adverse events85
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Death unrelated to research and related to disease progression | General disorders | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 17 | 26 | 17 |
| other | Abdominal pain | Gastrointestinal disorders | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 6 | 26 | 6 |
| other | Alkaline phosphatase elevation | Hepatobiliary disorders | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 7 | 26 | 7 |
| other | Allergic reaction | Immune system disorders | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 2 | 26 | 2 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 21 | 26 | 21 |
| other | Anemia | Blood and lymphatic system disorders | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 24 | 26 | 24 |
| other | Anorexia | Gastrointestinal disorders | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 14 | 26 | 14 |
| other | Anxiety | Psychiatric disorders | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 10 | 26 | 10 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 20 | 26 | 20 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 2 | 26 | 2 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 17 | 26 |
| Total, other adverse events | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 26 | 26 |
| Total, serious adverse events | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 14 | 26 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00005780
GET https://conductscience.org/api/trials/v1/NCT00005780/results?page=2