Trial · NCT00001337
Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
NCT00001337, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2025-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma. Trials, record NCT00001337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00001337
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
- NCT number
- NCT00001337
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 348 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma, Burkitt Lymphoma, Anaplastic Large-Cell Lymphoma, Gray Zone Lymphoma
- Interventions
- Etoposide, Rituximab, Prednisone, Cyclophosphamide, Vincristine, Doxorubicin, MRI, CT, Biopsy, PET scan, Laparotomy, Ondansetron, Prochlorperazine, Omeprazole, Docusate Sodium + Sennosides, Lactulose
- First posted
- 1999-11-04
- Last updated
- 2025-06-22
- Results first posted
- 2025-06-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response (Complete Response + Partial Response) | Time frame was from beginning of therapy until the end of therapy, an average of 6 months | Overall response defined as a Complete Response + Partial Response was measured by the Response Criteria. Complete Response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. Partial Response is 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month. |
| Primary | Progression Free Survival (PFS) | Progression free survival was calculated from study entry until progression or death from any cause. Median follow up of evaluable participants was 5 years (range 2-7 years) | The Dixon-Simon method will be used to determine whether large B-cell lymphomas expressing BCL-2 (+) participants may experience an improved progression free survival with Etoposide, VP-16, and Doxorubicin with Prednisone, Cyclophosphamide, and Rituximab (EPOCH-R) compared to EPOCH alone, and to obtain a concurrent, precisely determined measure of progression free survival. PFS is the time from start of treatment to documented evidence of disease progression. Progression is an increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions, or the appearance of any new lesions measured by the Response Criteria. |
| Secondary | Proportion of Participants With Serious and/or Non-serious Adverse Events Leading to Discontinuation of Therapy | Initiation of study drug until 30 days after treatment, an average of 6 months | Here is the proportion of participants with adverse events leading to discontinuation of therapy. 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 participant and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Time frame is from study entry until 30 days after completing study therapy, approximately 5 years. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response (Complete Response + Partial Response) | Time frame was from beginning of therapy until the end of therapy, an average of 6 months | 347/348 participants were analyzed because 1 was inevaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression Free Survival (PFS) | Progression free survival was calculated from study entry until progression or death from any cause. Median follow up of evaluable participants was 5 years (range 2-7 years) | 347/348 participants were analyzed because 1 was inevaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With Serious and/or Non-serious Adverse Events Leading to Discontinuation of Therapy | Initiation of study drug until 30 days after treatment, an average of 6 months | 347/348 participants were analyzed because one participant was enrolled and not treated. | proportion of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Time frame is from study entry until 30 days after completing study therapy, approximately 5 years. | 347/348 participants were analyzed because one participant was enrolled and not treated. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response (Complete Response + Partial Response) | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 216 | Participants | ||
| Overall Response (Complete Response + Partial Response) | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 94 | Participants | ||
| Progression Free Survival (PFS) | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 73 | Participants | ||
| Progression Free Survival (PFS) | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 41 | Participants | ||
| Proportion of Participants With Serious and/or Non-serious Adverse Events Leading to Discontinuation of Therapy | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 0.03 | proportion of participants | ||
| Proportion of Participants With Serious and/or Non-serious Adverse Events Leading to Discontinuation of Therapy | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 0.04 | proportion of participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 235 | Participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 112 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 235 | |
| Overall Study | STARTED | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 112 | |
| Overall Study | STARTED | Enrolled But Not Treated | 1 | |
| Overall Study | Follow-up Period Completed | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 148 | |
| Overall Study | Follow-up Period Completed | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 43 | |
| Overall Study | Follow-up Period Completed | Enrolled But Not Treated | 0 | |
| Overall Study | COMPLETED | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 148 | |
| Overall Study | COMPLETED | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 43 | |
| Overall Study | COMPLETED | Enrolled But Not Treated | 0 | |
| Overall Study | NOT COMPLETED | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 87 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events662
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 | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 124 | 235 | 210 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 19 | 112 | 27 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 83 | 235 | 121 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 12 | 112 | 17 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 127 | 235 | 231 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 15 | 112 | 29 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 50 | 235 | 72 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 14 | 112 | 16 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 20 | 235 | 24 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 0 | 112 | 0 |
1 to 10 of 662Source ClinicalTrials.gov
See all 662 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 28 | 235 |
| Total, all-cause mortality | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 13 | 112 |
| Total, other adverse events | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 235 | 235 |
| Total, other adverse events | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 112 | 112 |
| Total, serious adverse events | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | 146 | 235 |
| Total, serious adverse events | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 44 | 112 |
Source ClinicalTrials.gov
Papers10
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) vs EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide): Overall Response (Complete Response + Partial Response) | Trial comparisons |
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) vs EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide): Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Trial comparisons |
| With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) vs EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide): Progression Free Survival (PFS) | Trial comparisons |
| With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) vs EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide): deaths from any cause | Trial comparisons |
| With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) vs EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide): serious adverse events | Trial comparisons |
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/NCT00001337
GET https://conductscience.org/api/trials/v1/NCT00001337/events?page=2