Trial · NCT01077518
Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy
NCT01077518, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2020-03-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy. Trials, record NCT01077518. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01077518
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy
- NCT number
- NCT01077518
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 346 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Lymphoma, Follicular
- Interventions
- Ofatumumab, Bendamustine infusion, Ofatumumab and Bendamustine infusions (Arm A), Bendamustine infusion (Arm B)
- First posted
- 2010-03-01
- Last updated
- 2020-03-27
- Other registries' IDs
- eudract:2008-004177-17
- Results first posted
- 2020-03-27
- Limitations and caveats
- As the primary endpoint of the study was not met, secondary efficacy endpoints were not fully tested. The data being reported is for information only and not intended to be inferential.
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | From randomization to the date of first documented disease progression or death due to any cause (67.5 months) | PFS is defined as the time interval between randomization until disease progression or death (due to any cause). |
| Secondary | Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC | From randomization to the date of first documented disease progression or death due to any cause (67.5 months) | PFS is defined as the time interval between randomization until disease progression or death (due to any cause). |
| Secondary | Overall Response Rate (ORR) in All Participants Per IRC | From randomization until the 217th PFS event occurred, up to about 67.5 months | ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease \& disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions. |
| Secondary | Overall Response Rate (ORR) in Participants With FL Per IRC | From randomization until the 217th PFS event occurred, up to about 67.5 months | ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease \& disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions. |
| Secondary | Overall Survival (OS) in All Participants | From randomization up to about 89 months | The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact. |
| Secondary | Overall Survival (OS) in Participants With FL | From randomization up to about 89 months | The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact. |
| Secondary | Time to Response in All Participants Per IRC | From randomization to up to 67.5 months | Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment. |
| Secondary | Time to Response in Participants With FL Per IRC | From randomization to up to 67.5 months | Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment. |
| Secondary | Duration of Response in All Participants Per IRC | time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months | Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause. |
| Secondary | Duration of Response in Participants With FL Per IRC | time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months | Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
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) as Assessed by the Independent Review Committee (IRC) | From randomization to the date of first documented disease progression or death due to any cause (67.5 months) | ITT: The Intent-to-Treat (ITT) population included subjects who were randomized in the study. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC | From randomization to the date of first documented disease progression or death due to any cause (67.5 months) | Subjects in ITT with Follicular Lymphoma (FL). ITT population included subjects who were randomized in the study. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) in All Participants Per IRC | From randomization until the 217th PFS event occurred, up to about 67.5 months | ITT: The ITT population included subjects who were randomized in the study. | Percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) in Participants With FL Per IRC | From randomization until the 217th PFS event occurred, up to about 67.5 months | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) in All Participants | From randomization up to about 89 months | ITT: The ITT population included subjects who were randomized in the study. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Participants With FL | From randomization up to about 89 months | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | months | MEDIAN |
| SECONDARY | Time to Response in All Participants Per IRC | From randomization to up to 67.5 months | ITT: The ITT population included subjects who were randomized in the study. | Months | MEDIAN |
| SECONDARY | Time to Response in Participants With FL Per IRC | From randomization to up to 67.5 months | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | Months | MEDIAN |
| SECONDARY | Duration of Response in All Participants Per IRC | time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months | ITT: The ITT population included subjects who were randomized in the study. | months | MEDIAN |
| SECONDARY | Duration of Response in Participants With FL Per IRC | time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | months | MEDIAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group318
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) as Assessed by the Independent Review Committee (IRC) | Ofa + Benda (Arm A) | 16.66 | 95% Confidence Interval 12.81 to 19.68 | months | |
| Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | Benda (Arm B) | 13.83 | 95% Confidence Interval 11.30 to 16.89 | months | |
| Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC | Ofa + Benda (Arm A) | 16.62 | 95% Confidence Interval 11.17 to 20.47 | months | |
| Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC | Benda (Arm B) | 12.12 | 95% Confidence Interval 10.94 to 16.62 | months | |
| Overall Response Rate (ORR) in All Participants Per IRC | Ofa + Benda (Arm A) | 73 | 95% Confidence Interval 66 to 80 | Percentage of participants | |
| Overall Response Rate (ORR) in All Participants Per IRC | Benda (Arm B) | 75 | 95% Confidence Interval 67 to 81 | Percentage of participants | |
| Overall Response Rate (ORR) in Participants With FL Per IRC | Ofa + Benda (Arm A) | 77 | 95% Confidence Interval 68 to 84 | Percentage of participants | |
| Overall Response Rate (ORR) in Participants With FL Per IRC | Benda (Arm B) | 76 | 95% Confidence Interval 67 to 83 | Percentage of participants | |
| Overall Survival (OS) in All Participants | Ofa + Benda (Arm A) | 59.76 | 95% Confidence Interval 46.63 to NA | months | |
| Overall Survival (OS) in All Participants | Benda (Arm B) | 58.22 | 95% Confidence Interval 36.44 to NA | months |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase - no Optional Ofa | STARTED | Ofa + Benda (Arm A) | 173 | |
| Treatment Phase - no Optional Ofa | STARTED | Benda (Arm B) | 173 | |
| Treatment Phase - no Optional Ofa | STARTED | Optional Ofa | 0 | |
| Treatment Phase - no Optional Ofa | Completed 5-year Follow-up | Ofa + Benda (Arm A) | 64 | |
| Treatment Phase - no Optional Ofa | Completed 5-year Follow-up | Benda (Arm B) | 64 | |
| Treatment Phase - no Optional Ofa | Completed 5-year Follow-up | Optional Ofa | 0 | |
| Treatment Phase - no Optional Ofa | Safety Population | Ofa + Benda (Arm A) | 172 | |
| Treatment Phase - no Optional Ofa | Safety Population | Benda (Arm B) | 170 | |
| Treatment Phase - no Optional Ofa | Safety Population | Optional Ofa | 0 | |
| Treatment Phase - no Optional Ofa | COMPLETED | Ofa + Benda (Arm A) | 95 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events956
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 | Anaemia | Blood and lymphatic system disorders | Ofa + Benda (Arm A) | 31 | 172 | |
| other | Anaemia | Blood and lymphatic system disorders | Benda (Arm B) | 46 | 170 | |
| other | Anaemia | Blood and lymphatic system disorders | Optional Ofa | 0 | 32 | |
| other | Anaemia | Blood and lymphatic system disorders | Ofa + Benda (Arm A) + Benda (Arm B) + Optional Ofa | 77 | 342 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ofa + Benda (Arm A) | 25 | 172 | |
| other | Leukopenia | Blood and lymphatic system disorders | Benda (Arm B) | 21 | 170 | |
| other | Leukopenia | Blood and lymphatic system disorders | Optional Ofa | 1 | 32 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ofa + Benda (Arm A) + Benda (Arm B) + Optional Ofa | 46 | 342 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Ofa + Benda (Arm A) | 17 | 172 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Benda (Arm B) | 17 | 170 |
1 to 10 of 956Source ClinicalTrials.gov
See all 956 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ofa + Benda (Arm A) | 66 | 172 |
| Total, all-cause mortality | Benda (Arm B) | 71 | 170 |
| Total, all-cause mortality | Optional Ofa | 15 | 32 |
| Total, all-cause mortality | Ofa + Benda (Arm A) + Benda (Arm B) + Optional Ofa | 137 | 342 |
| Total, other adverse events | Ofa + Benda (Arm A) | 158 | 172 |
| Total, other adverse events | Benda (Arm B) | 162 | 170 |
| Total, other adverse events | Optional Ofa | 21 | 32 |
| Total, other adverse events | Ofa + Benda (Arm A) + Benda (Arm B) + Optional Ofa | 320 | 342 |
| Total, serious adverse events | Ofa + Benda (Arm A) | 72 | 172 |
| Total, serious adverse events | Benda (Arm B) | 84 | 170 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33973233 | DERIVED |
Source PubMed
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/NCT01077518
GET https://conductscience.org/api/trials/v1/NCT01077518/registered?page=2