Trial · NCT01200589
Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy
NCT01200589, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2018-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy. Trials, record NCT01200589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01200589
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy
- NCT number
- NCT01200589
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 438 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Ofatumumab, Rituximab, Ofatumumab, Rituximab
- First posted
- 2010-09-13
- Last updated
- 2018-05-16
- Results first posted
- 2018-05-16
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) - Number of Participants With PFS Events | 200 weeks | Disease response assessed by modified 2007 Revised Response Criteria for Malignant Lymphoma. Nodal disease, PD: 1)prev. normal node (\<=1.5cm x \<=1.0cm) that incr. to \>2.0 x ≥1.5cm; 2)≥50% incr. from nadir product of perpendicular diameter (PPD) of any prev. involved node with long axis \>1.5cm at baseline (BL) (must incr. by ≥0.5mm \& to \>2.0cm) OR ≥50% incr. from nadir in long axis of any prev. inv. node with long axis of \>1.5cm at BL (long axis must incr. by ≥0.5mm \& to \>2.0cm); or 3)≥50% incr. from nadir in the sums of prod. of diameters (SPD) of target nodes \& ≥1 node with long axis \>1.5cm. Extranodal, PD 1)any new lesion \>2.0 x ≥1.5cm not attributed to non-lymphoma causes; 2)≥50% incr. from nadir PPD of any targ. les. \& \>5mm incr. in either axis \& les. must measure \>1.5cm x ≥1.5cm OR ≥50% incr. from nadir in long axis of any targ. les. \& \>5mm incr. in either axis \& les. must measure \>1.5cm x ≥1.5cm; or 3)≥50% incr. from nadir in SPD of targ. nodes \& ≥1 node with long axis \>1.5cm. |
| Secondary | Number of Participants With Complete Response (CR) | 200 weeks | Complete response was assessed according to modified 2007 Revised Response Criteria for Malignant Lymphoma (RRCML) and defined as follows: 1) complete disappearance of all detectable clinical evidence of disease (all target nodes regressing to \<=1.5cm in the long axis and all non-target lesions being normal in size by imaging) and disease-related symptoms if present before therapy; 2) the spleen/liver, if considered enlarged due to lymphoma based on CT scan prior to therapy, would be normal and nodules should disappear; and 3) if bone marrow was involved before treatment, the infiltrate must clear on repeat bone marrow biopsy. Computed tomography (CT) scans of the neck, thorax, abdomen and pelvis were performed as part of the efficacy evaluation. |
| Secondary | Number of Participants With Overall Response (OR) | 200 weeks | The overall response rate (ORR) was defined as the number of participants achieving a CR or partial response (PR). from start of randomization until disease progression, or the start of a new anti-cancer therapy. Disease response was assessed according to modified 2007 Revised Response Criteria for Malignant Lymphoma (RRCML). Computed tomography (CT) scans of the neck, thorax, abdomen and pelvis were performed as part of the efficacy evaluation. Bone marrow examination to confirm a suspected complete response (CR) was performed within 8 weeks following the onset of a CT scan confirmed CR. |
| Secondary | Number of Deaths | 200 weeks | The number of deaths were assessed. |
| Secondary | Number of Participants With Infection Related Adverse Events | 200 weeks | The number of participants with infection related adverse events was assessed. |
| Secondary | Number of Participants With Infusion Related Adverse Events Due to Study Drug | 36 weeks + 60 days | The number of participants with infusion related adverse events due to study drug was assessed. |
| Secondary | Number of Participants With Myelosuppression Adverse Events | 200 weeks | The number of participants with myelosuppression adverse events was assessed. |
| Secondary | Duration of Response (DOR) | 200 weeks | |
| Secondary | Time to Next Treatment | 200 weeks | |
| Secondary | Pharmacokinetics | 70 weeks |
Source ClinicalTrials.gov
Outcomes10
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) - Number of Participants With PFS Events | 200 weeks | The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants With Complete Response (CR) | 200 weeks | The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants With Overall Response (OR) | 200 weeks | The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed. | Participants | NUMBER |
| SECONDARY | Number of Deaths | 200 weeks | The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants With Infection Related Adverse Events | 200 weeks | The safety set, comprised of all participants who received one dose of study drug, was analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants With Infusion Related Adverse Events Due to Study Drug | 36 weeks + 60 days | The safety set, comprised of all participants who received one dose of study drug, was analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants With Myelosuppression Adverse Events | 200 weeks | The safety set, comprised of all participants who received one dose of study drug, was analyzed. | Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | 200 weeks | The analysis of this outcome was not performed due to the early termination of the study. Please see the brief summary of the protocol section for additional details. | ||
| SECONDARY | Time to Next Treatment | 200 weeks | The analysis of this outcome was not performed due to the early termination of the study. Please see the brief summary of the protocol section for additional details. | ||
| SECONDARY | Pharmacokinetics | 70 weeks | The analysis of this outcome was not performed due to the early termination of the study. Please see the brief summary of the protocol section for additional details. |
Source ClinicalTrials.gov
Results by group14
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) - Number of Participants With PFS Events | Ofatumumab | 114 | Participants | ||
| Progression-free Survival (PFS) - Number of Participants With PFS Events | Rituximab | 117 | Participants | ||
| Number of Participants With Complete Response (CR) | Ofatumumab | 36 | Participants | ||
| Number of Participants With Complete Response (CR) | Rituximab | 44 | Participants | ||
| Number of Participants With Overall Response (OR) | Ofatumumab | 110 | Participants | ||
| Number of Participants With Overall Response (OR) | Rituximab | 144 | Participants | ||
| Number of Deaths | Ofatumumab | 28 | Participants | ||
| Number of Deaths | Rituximab | 30 | Participants | ||
| Number of Participants With Infection Related Adverse Events | Ofatumumab | 69 | Participants | ||
| Number of Participants With Infection Related Adverse Events | Rituximab | 81 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ofatumumab | 219 | |
| Overall Study | STARTED | Rituximab | 219 | |
| Overall Study | Intent-to-treat (ITT) Analysis Set | Ofatumumab | 219 | |
| Overall Study | Intent-to-treat (ITT) Analysis Set | Rituximab | 219 | |
| Overall Study | Safety Set | Ofatumumab | 217 | |
| Overall Study | Safety Set | Rituximab | 218 | |
| Overall Study | COMPLETED | Ofatumumab | 29 | |
| Overall Study | COMPLETED | Rituximab | 30 | |
| Overall Study | NOT COMPLETED | Ofatumumab | 190 | |
| Overall Study | NOT COMPLETED | Rituximab | 189 |
Source ClinicalTrials.gov
Adverse events232
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 | Neutropenia | Blood and lymphatic system disorders | Ofatumumab | 6 | 217 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab | 16 | 218 | |
| other | Abdominal pain | Gastrointestinal disorders | Ofatumumab | 12 | 217 | |
| other | Abdominal pain | Gastrointestinal disorders | Rituximab | 7 | 218 | |
| other | Constipation | Gastrointestinal disorders | Ofatumumab | 17 | 217 | |
| other | Constipation | Gastrointestinal disorders | Rituximab | 11 | 218 | |
| other | Diarrhoea | Gastrointestinal disorders | Ofatumumab | 20 | 217 | |
| other | Diarrhoea | Gastrointestinal disorders | Rituximab | 15 | 218 | |
| other | Nausea | Gastrointestinal disorders | Ofatumumab | 19 | 217 | |
| other | Nausea | Gastrointestinal disorders | Rituximab | 16 | 218 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ofatumumab | ||
| Total, all-cause mortality | Rituximab | ||
| Total, other adverse events | Ofatumumab | 177 | 217 |
| Total, other adverse events | Rituximab | 150 | 218 |
| Total, serious adverse events | Ofatumumab | 38 | 217 |
| Total, serious adverse events | Rituximab | 37 | 218 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32810220 | 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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ofatumumab vs Rituximab: Number of Participants With Complete Response (CR) | Trial comparisons |
| Ofatumumab vs Rituximab: Number of Participants With Infusion Related Adverse Events Due to Study Drug | Trial comparisons |
| Ofatumumab vs Rituximab: Number of Participants With Overall Response (OR) | Trial comparisons |
| Ofatumumab vs Rituximab: Progression-free Survival (PFS) - Number of Participants With PFS Events | Trial comparisons |
| Ofatumumab vs Rituximab: Number of Deaths | Trial comparisons |
| Ofatumumab vs Rituximab: Number of Participants With Myelosuppression Adverse Events | Trial comparisons |
| Ofatumumab vs Rituximab: Number of Participants With Infection Related Adverse Events | Trial comparisons |
| Ofatumumab vs Rituximab: serious adverse events | 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/NCT01200589
GET https://conductscience.org/api/trials/v1/NCT01200589/events?page=2