Comparison · NCT00001337-cfcc889f
With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) vs EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide): Progression Free Survival (PFS)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) vs EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide): Progression Free Survival (PFS). Trial comparisons, record NCT00001337-cfcc889f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00001337-cfcc889f
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.311 | 0.255 | 0.372 | wilson | |
| Risk in group 2 | 0.366 | 0.283 | 0.458 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0554 | -0.163 | 0.0484 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.849 | 0.623 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 0.78 | 0.486 | 1.25 | log | |
Number needed to treat, for one fewer participant with the outcome on With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) than on EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | 18 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) | Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. | 73 | 235 | OG000 |
| Group 2 | EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) | Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir. | 41 | 112 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Progression Free Survival (PFS)
- Description
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.
- Time frame
- 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)
- Population
- 347/348 participants were analyzed because 1 was inevaluable for response.
Source ClinicalTrials.gov
Trial
- Title
- Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
- NCT number
- NCT00001337
- Phases
- PHASE2
- 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
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2025-06-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00001337?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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