Trial · NCT01092182
Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma
NCT01092182, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2021-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma. Trials, record NCT01092182. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01092182
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma
- NCT number
- NCT01092182
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 194 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Burkitt Lymphoma, Diffuse Large B-cell Lymphoma, c-MYC Positive, Plasmablastic Lymphoma
- Interventions
- EPOCH-R, EPOCH-RR
- First posted
- 2010-03-24
- Last updated
- 2023-04-27
- Results first posted
- 2021-10-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval | Time of progression or death at 4 years | PFS is the time interval from start of treatment to documented evidence of disease progression. Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of \< 1.5 cm (\< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. |
| Primary | Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval | At 4 years | EFS was determined from the date of enrolment in the study until the date of progression, last documentation of disease at or after the last treatment cycle, death, or last follow-up (whichever occurred first). Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of \< 1.5 cm (\< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. |
| Primary | Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval | At 4 years | OS was calculated from the enrolment date until date of death or last follow-up using the Kaplan Meier. Kaplan-Meier curves were constructed with an 95% confidence interval. |
| Secondary | Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2 | After 2 cycles of therapy and prior to cycle 3 | The predictive value of early FDG-PET/CT scans on PFS was assessed after cycle 2. PFS is the time interval from start of treatment to documented evidence of disease progression, assessed by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of \< 1.5 cm (\< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. |
| Other | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C. | Here is the number of participants with serious and 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
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval | Time of progression or death at 4 years | Those participants that were not analyzed for PFS were screen failures (did not have MYC+ Diffuse Large B-Cell Lymphoma (DLBCL). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval | At 4 years | Those participants that were not analyzed for EFS were screen failures (did not have MYC+ Diffuse Large B-Cell Lymphoma (DLBCL). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval | At 4 years | Those participants that were not analyzed for OS were screen failures (did not have MYC+ Diffuse Large B-Cell Lymphoma (DLBCL). | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2 | After 2 cycles of therapy and prior to cycle 3 | 51/98 participants and 34/81 participants did not receive a PET scan. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval | Group A - Low-risk Burkitt Lymphoma (BL) | 100 | 95% Confidence Interval 1 to 100 | percentage of participants | |
| Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval | Group B - High-Risk Burkitt Lymphoma (BL) | 82.1 | 95% Confidence Interval 72.7 to 88.5 | percentage of participants | |
| Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 71.0 | 95% Confidence Interval 56.5 to 81.4 | percentage of participants | |
| Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval | Group A - Low-risk Burkitt Lymphoma (BL) | 100 | 95% Confidence Interval 1 to 100 | percentage of participants | |
| Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval | Group B - High-Risk Burkitt Lymphoma (BL) | 82.1 | 95% Confidence Interval 72.7 to 88.5 | percentage of participants | |
| Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 71.0 | 95% Confidence Interval 58.5 to 81.4 | percentage of participants | |
| Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval | Group A - Low-risk Burkitt Lymphoma (BL) | 100 | 95% Confidence Interval 1 to 100 | percentage of participants | |
| Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval | Group B - High-Risk Burkitt Lymphoma (BL) | 84.9 | 95% Confidence Interval 75.8 to 90.8 | percentage of participants | |
| Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 76.7 | 95% Confidence Interval 62.6 to 86.1 | percentage of participants | |
Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2 | Group A - Low-risk Burkitt Lymphoma (BL) | 100 | 95% Confidence Interval 1 to 100 | percentage of participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low-risk Burkitt Lymphoma (BL) | 15 | |
| Overall Study | STARTED | High-Risk Burkitt Lymphoma (BL) | 98 | |
| Overall Study | STARTED | High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 81 | |
| Overall Study | COMPLETED | Low-risk Burkitt Lymphoma (BL) | 14 | |
| Overall Study | COMPLETED | High-Risk Burkitt Lymphoma (BL) | 80 | |
| Overall Study | COMPLETED | High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 53 | |
| Overall Study | NOT COMPLETED | Low-risk Burkitt Lymphoma (BL) | 1 | |
| Overall Study | NOT COMPLETED | High-Risk Burkitt Lymphoma (BL) | 18 | |
| Overall Study | NOT COMPLETED | High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 28 |
Source ClinicalTrials.gov
Adverse events1,074
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 | Abdominal distension | Gastrointestinal disorders | Group A - Low-risk Burkitt Lymphoma (BL) | 0 | 15 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Group B - High-Risk Burkitt Lymphoma (BL) | 3 | 98 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 0 | 81 | 0 |
| other | Abdominal infection | Gastrointestinal disorders | Group A - Low-risk Burkitt Lymphoma (BL) | 0 | 15 | 0 |
| other | Abdominal infection | Gastrointestinal disorders | Group B - High-Risk Burkitt Lymphoma (BL) | 2 | 98 | 2 |
| other | Abdominal infection | Gastrointestinal disorders | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 0 | 81 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Group A - Low-risk Burkitt Lymphoma (BL) | 2 | 15 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Group B - High-Risk Burkitt Lymphoma (BL) | 8 | 98 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 5 | 81 | 5 |
| other | Activated partial thromboplastin time prolonged | Investigations | Group A - Low-risk Burkitt Lymphoma (BL) | 0 | 15 | 0 |
1 to 10 of 1,074Source ClinicalTrials.gov
See all 1,074 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A - Low-risk Burkitt Lymphoma (BL) | 0 | 15 |
| Total, all-cause mortality | Group B - High-Risk Burkitt Lymphoma (BL) | 16 | 98 |
| Total, all-cause mortality | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 3 | 81 |
| Total, other adverse events | Group A - Low-risk Burkitt Lymphoma (BL) | 13 | 15 |
| Total, other adverse events | Group B - High-Risk Burkitt Lymphoma (BL) | 88 | 98 |
| Total, other adverse events | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 71 | 81 |
| Total, serious adverse events | Group A - Low-risk Burkitt Lymphoma (BL) | 3 | 15 |
| Total, serious adverse events | Group B - High-Risk Burkitt Lymphoma (BL) | 58 | 98 |
| Total, serious adverse events | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 33 | 81 |
Source ClinicalTrials.gov
Papers2
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/NCT01092182
GET https://conductscience.org/api/trials/v1/NCT01092182/events?page=2