Trial · NCT01294579
Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL)
NCT01294579, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2018-08-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL). Trials, record NCT01294579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01294579
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL)
- NCT number
- NCT01294579
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Ofatumumab, Bendamustine
- First posted
- 2011-02-11
- Last updated
- 2018-08-09
- Results first posted
- 2018-08-09
- Limitations and caveats
- The study was terminated early based on the evolution of the current therapeutic treatment landscape in Non Hodgkin Indolent Lymphomas and low enrollment rates for this trial.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Remission (CR) Rate of Induction Therapy After Cycle 6 (28 Days) (FAS) | Baseline up to 24 weeks | Complete response (CR) included all of the following: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. All target nodes had to have regressed to ≤ 1.5cm in the longest diameter. Non-measureable nodes 1.1 to 1.5cm in the longest diameter and \>1cm in the short axis at baseline had to regress to ≤ 1cm in the short axis by visual estimation; enlarged spleen or liver (with nodules) must have returned to normal size and nodules disappeared and if bone marrow was involved, infiltrate had to have cleared on repeat biopsy sample. CR was not valid without imaging data. The corresponding 2-sided 95% exact confidence interval (CI) of the response rate was estimated by the Clopper-Pearson method. |
| Secondary | Overall Response Rate (ORR) During Induction Phase After Cycle 6 (FAS) | Baseline up to 24 weeks | The overall response = CR (defined in Primary Outcome) + Partial Response (PR) which required all of the following: \> or = to 50% decrease from baseline in target nodules; \> or = to 50% decrease in hepatic/splenic nodules and no increase in liver or spleen size; no unequivocal progression in non-target lestions; no new sites of disease. |
| Secondary | Conversion Rate of Partial Response in Induction Phase to Complete Response With Maintenance Ofatumumab (FAS) | Partial response in induction phase up to 24 weeks | Rate of conversion from PR in the Induction phase, to CR with maintenance ofatumumab in subjects who have a PR with induction therapy with ofatumumab and bendamustine |
| Secondary | Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS) | Baseline up to approximately 30 months | Progression free survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS criteria: A previously normal node (≤ 1.5 x ≤ 1.0cm), including nodes that were not previously visible, must increase to \>2.0 x ≥ 1.5cm; ≥ 50% increase from nadir in the PPD of any target node. The long axis must increase by at least 5 mm and to \>2.0cm.; ≥ 50% increase from nadir in the long axis of any target node. The long axis must increase by at least 5 mm and to \>2.0 cm.; ≥ 50% increase from nadir in the SPD of target nodes and at least one node should have a long axis \>1.5 cm. |
| Secondary | Kaplan-Meier Estimates of Progression Free Survival up to 30 Months (FAS) | Baseline up to approximately 30 months | Progression Free Survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS events: progression documented between scheduled visits, death before first PD assessment (or death at baseline or prior to any adequate assessments), death between adequate assessment visits. For the PFS analysis, the survival function was estimated using Kaplan-Meier estimates. |
| Secondary | Pharmacokinetic Profile Which Includes Measuring Blood Levels of Ofatumumab and Bendamustine in Combination and Ofatumumab Alone During Maintenance Treatment and Measuring Blood Levels of Circulating B Cell | up to 30 months | Due to recruitment issues, this data analysis was not done per changes in planned analysis. This data was only presented as patient listings. The statistical analysis plan was modified to indicate that Pharmacokinetic/Pharmacodynamic exploratory analyses were not done. |
| Secondary | All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months | Baseline up to approximately 30 months | Deaths were collected and were considered to be an on treatment death up to 60 days post treatment. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Remission (CR) Rate of Induction Therapy After Cycle 6 (28 Days) (FAS) | Baseline up to 24 weeks | percentage of participants | NUMBER | |
| SECONDARY | Overall Response Rate (ORR) During Induction Phase After Cycle 6 (FAS) | Baseline up to 24 weeks | percentage of participants | NUMBER | |
| SECONDARY | Conversion Rate of Partial Response in Induction Phase to Complete Response With Maintenance Ofatumumab (FAS) | Partial response in induction phase up to 24 weeks | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS) | Baseline up to approximately 30 months | percentage of participants | NUMBER | |
| SECONDARY | Kaplan-Meier Estimates of Progression Free Survival up to 30 Months (FAS) | Baseline up to approximately 30 months | months | MEDIAN | |
| SECONDARY | Pharmacokinetic Profile Which Includes Measuring Blood Levels of Ofatumumab and Bendamustine in Combination and Ofatumumab Alone During Maintenance Treatment and Measuring Blood Levels of Circulating B Cell | up to 30 months | |||
| SECONDARY | All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months | Baseline up to approximately 30 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Remission (CR) Rate of Induction Therapy After Cycle 6 (28 Days) (FAS) | Ofatumumab and Bendamustine | 24.5 | 95% Confidence Interval 13.3 to 38.9 | percentage of participants | |
| Overall Response Rate (ORR) During Induction Phase After Cycle 6 (FAS) | Ofatumumab and Bendamustine | 67.3 | 95% Confidence Interval 52.5 to 80.1 | percentage of participants | |
| Conversion Rate of Partial Response in Induction Phase to Complete Response With Maintenance Ofatumumab (FAS) | Ofatumumab and Bendamustine | 37.5 | 95% Confidence Interval 15.2 to 64.6 | percentage of participants | |
| Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS) | Ofatumumab and Bendamustine | PFS events | 42.9 | percentage of participants | |
| Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS) | Ofatumumab and Bendamustine | PFS events - Progression | 32.7 | percentage of participants | |
| Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS) | Ofatumumab and Bendamustine | PFS events - Death | 10.2 | percentage of participants | |
| Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS) | Ofatumumab and Bendamustine | censored - follow-up ended | 57.1 | percentage of participants | |
| Kaplan-Meier Estimates of Progression Free Survival up to 30 Months (FAS) | Ofatumumab and Bendamustine | 29.7 | 95% Confidence Interval 17.3 to NA | months | |
| All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months | Ofatumumab and Bendamustine | Disease progression | 3 | participants | |
| All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months | Ofatumumab and Bendamustine | Pneumonia | 1 | participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ofatumumab and Bendamustine | 49 | |
| Overall Study | COMPLETED | Ofatumumab and Bendamustine | 14 | |
| Overall Study | NOT COMPLETED | Ofatumumab and Bendamustine | 35 |
Source ClinicalTrials.gov
Adverse events79
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 | Ofatumumab + Bendamustine | 10 | 49 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ofatumumab + Bendamustine | 6 | 49 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Ofatumumab + Bendamustine | 3 | 49 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ofatumumab + Bendamustine | 11 | 49 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ofatumumab + Bendamustine | 7 | 49 | |
| other | External ear pain | Ear and labyrinth disorders | Ofatumumab + Bendamustine | 3 | 49 | |
| other | Abdominal pain | Gastrointestinal disorders | Ofatumumab + Bendamustine | 5 | 49 | |
| other | Constipation | Gastrointestinal disorders | Ofatumumab + Bendamustine | 14 | 49 | |
| other | Diarrhoea | Gastrointestinal disorders | Ofatumumab + Bendamustine | 13 | 49 | |
| other | Nausea | Gastrointestinal disorders | Ofatumumab + Bendamustine | 24 | 49 |
1 to 10 of 79Source ClinicalTrials.gov
See all 79 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ofatumumab + Bendamustine | 7 | 49 |
| Total, other adverse events | Ofatumumab + Bendamustine | 47 | 49 |
| Total, serious adverse events | Ofatumumab + Bendamustine | 18 | 49 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33448893 | 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/NCT01294579
GET https://conductscience.org/api/trials/v1/NCT01294579/events?page=2