Trial · NCT00486759
A Study of Bevacizumab (Avastin) in Combination With Rituximab (MabThera) and CHOP (Cyclophosphamide, Hydroxydaunorubicin [Doxorubicin], Oncovin [Vincristine], Prednisone) Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
NCT00486759, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2012-12-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Bevacizumab (Avastin) in Combination With Rituximab (MabThera) and CHOP (Cyclophosphamide, Hydroxydaunorubicin [Doxorubicin], Oncovin [Vincristine], Prednisone) Chemotherapy in Patients With Diffuse Large B-cell Lymphoma. Trials, record NCT00486759. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00486759
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Bevacizumab (Avastin) in Combination With Rituximab (MabThera) and CHOP (Cyclophosphamide, Hydroxydaunorubicin [Doxorubicin], Oncovin [Vincristine], Prednisone) Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
- NCT number
- NCT00486759
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 787 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- B-cell Lymphoma
- Interventions
- Bevacizumab, Rituximab, CHOP, Placebo
- First posted
- 2007-06-15
- Last updated
- 2017-07-25
- Results first posted
- 2012-12-31
- Limitations and caveats
- Due to premature termination of the study, the efficacy results should be interpreted with caution.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Baseline to end of the study (up to 4 years, 4 months) | PFS was defined as the time from the date of randomization to the date of disease progression (PD)/relapse, as determined by the investigator, or death from any cause, whichever occurred earlier. A patient with PD/relapse must meet at least 1 of the following criteria: (1) Appearance of any new lesion \> 1.0 cm in the short axis during or at the end of therapy. (2) ≥ 50 % increase from nadir in the sum of the products of diameters (SPD, maximum diameter of a tumor x largest diameter perpendicular to the maximum diameter) of any previously involved nodes, in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis \< 1.0 cm must increase by ≥ 50% to a size of 1.5 x 1.5 cm or \> 1.5 cm in the long axis. (3) ≥ 50 % increase in the greatest diameter of any previously identified node \> 1.0 cm in its short axis or in the SPD of more than 1 node. |
| Secondary | Overall Survival | Baseline to end of the study (up to 4 years, 4 months) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. |
| Secondary | Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma | At the end of treatment (Cycle 8, up to 12 months) | OR = a complete response (CR), an unconfirmed CR, or a partial response (PR). CR = Complete disappearance of disease and disease-related symptoms. All lymph nodes and nodal masses regressed on computed tomography (CT) to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and \> 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on physical examination, normal size by imaging, and disappearance of nodules related to lymphoma. If bone marrow was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. No new sites of disease. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Baseline to end of the study (up to 4 years, 4 months) | Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments. | Months | MEDIAN |
| SECONDARY | Overall Survival | Baseline to end of the study (up to 4 years, 4 months) | Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments. | Months | MEDIAN |
| SECONDARY | Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma | At the end of treatment (Cycle 8, up to 12 months) | Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments. | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Bevacizumab + Rituximab + CHOP | 40.2 | Inter-Quartile Range 12.1 to NA | Months | |
| Progression-free Survival (PFS) | Placebo + Rituximab + CHOP | 42.9 | Inter-Quartile Range 13.6 to NA | Months | |
| Overall Survival | Bevacizumab + Rituximab + CHOP | NA | Inter-Quartile Range 34.0 to NA | Months | |
| Overall Survival | Placebo + Rituximab + CHOP | NA | Inter-Quartile Range 42.9 to NA | Months | |
| Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma | Bevacizumab + Rituximab + CHOP | 63.1 | Percentage of patients | ||
| Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma | Placebo + Rituximab + CHOP | 70.5 | Percentage of patients |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment | STARTED | Bevacizumab + Rituximab + CHOP | 390 | |
| Treatment | STARTED | Placebo + Rituximab + CHOP | 397 | |
| Treatment | COMPLETED | Bevacizumab + Rituximab + CHOP | 203 | |
| Treatment | COMPLETED | Placebo + Rituximab + CHOP | 260 | |
| Treatment | NOT COMPLETED | Bevacizumab + Rituximab + CHOP | 187 | |
| Treatment | NOT COMPLETED | Placebo + Rituximab + CHOP | 137 | |
| Safety Follow-up | STARTED | Bevacizumab + Rituximab + CHOP | 203 | |
| Safety Follow-up | STARTED | Placebo + Rituximab + CHOP | 260 | |
| Safety Follow-up | COMPLETED | Bevacizumab + Rituximab + CHOP | 64 | |
| Safety Follow-up | COMPLETED | Placebo + Rituximab + CHOP | 142 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events564
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 | Nausea | Gastrointestinal disorders | Bevacizumab + Rituximab + CHOP | 107 | 395 | |
| other | Nausea | Gastrointestinal disorders | Placebo + Rituximab + CHOP | 106 | 386 | |
| other | Diarrhoea | Gastrointestinal disorders | Bevacizumab + Rituximab + CHOP | 95 | 395 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + Rituximab + CHOP | 81 | 386 | |
| other | Constipation | Gastrointestinal disorders | Bevacizumab + Rituximab + CHOP | 88 | 395 | |
| other | Constipation | Gastrointestinal disorders | Placebo + Rituximab + CHOP | 70 | 386 | |
| other | Vomiting | Gastrointestinal disorders | Bevacizumab + Rituximab + CHOP | 56 | 395 | |
| other | Vomiting | Gastrointestinal disorders | Placebo + Rituximab + CHOP | 70 | 386 | |
| other | Stomatitis | Gastrointestinal disorders | Bevacizumab + Rituximab + CHOP | 33 | 395 | |
| other | Stomatitis | Gastrointestinal disorders | Placebo + Rituximab + CHOP | 36 | 386 |
1 to 10 of 564Source ClinicalTrials.gov
See all 564 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab + Rituximab + CHOP | ||
| Total, all-cause mortality | Placebo + Rituximab + CHOP | ||
| Total, other adverse events | Bevacizumab + Rituximab + CHOP | 346 | 395 |
| Total, other adverse events | Placebo + Rituximab + CHOP | 331 | 386 |
| Total, serious adverse events | Bevacizumab + Rituximab + CHOP | 224 | 395 |
| Total, serious adverse events | Placebo + Rituximab + CHOP | 173 | 386 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bevacizumab + Rituximab + CHOP vs Placebo + Rituximab + CHOP: serious adverse events |
Source 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/NCT00486759
GET https://conductscience.org/api/trials/v1/NCT00486759/events?page=2