Trial · NCT01039376
Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy
NCT01039376, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2015-04-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy. Trials, record NCT01039376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01039376
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy
- NCT number
- NCT01039376
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 480 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Leukaemia, Lymphocytic, Chronic
- Interventions
- Ofatumumab, Observation
- First posted
- 2009-12-25
- Last updated
- 2019-07-30
- Results first posted
- 2015-04-21
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival, as Assessed by the Investigator | From randomization until progression or death (up to 79 months) | Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the investigator according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (\>1.5 centimeter \[cm\]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia. |
| Primary | Progression-free Survival, as Assessed by the Independent Review Committee (IRC) | From randomization until progression or death (up to 79 months) | Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the IRC according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (\>1.5 centimeter \[cm\]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia. |
| Secondary | Overall Survival | From randomization until death (up to 88 months) | Overall survival is defined as time from randomization to date of death. |
| Secondary | Number of Participants With Improvement in Response From Baseline | From Baseline until the end of the study (up to 88 months) | Improvement in response was assessed by calculating the percentage of participants who changed from partial response (PR) at Baseline to complete response during the study. |
| Secondary | Time to Next Therapy | From randomization until the end of the study (up to 88 months) | Time to next therapy is defined as the time from randomization to the date of receiving the next CLL treatment. |
| Secondary | Progression-free Survival After Next-line Therapy | From randomization until progression or death (up to 88 months) | Progression-free survival after next-line therapy is defined as the time from randomization until progression or death following the next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy and who did not have progression or death after next-line therapy were censored at their last date of contact. Participant who died prior to next-line therapy, was counted as an event. |
| Secondary | Time to Progression After Next-line Therapy | From randomization until progression or death (up to 88 months) | Time to progression after next-line therapy is defined as the time from progression following randomization until progression or death following next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy with a PD prior to receiving next line therapy and who did not had progression or death after next-line therapy were censored at their last date of contact. If a participant died prior to next-line therapy, this was counted as an event. |
| Secondary | Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16) | From randomization until the end of the study (up to 47 months) | The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects (\[TSE\], 4 items), disease symptoms (disease effects scale \[DES\], 4 items), and infection (4 items) - and single-item scales (social activities \[Social Problems (SP) Scale\] and future health worries \[Future Health (FH) Scale\]). These are measured on a four-point Likert scale, where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 = no symptoms or problems and 100 = severe symptoms or problems. Changes from Baseline were analyzed by a mixed model-repeated measures analysis of covariance (ANCOVA). |
| Secondary | Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score | From randomization until the end of the study (up to 47 months) | The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items), pain (2 items), fatigue (3 items), nausea and vomiting (2 items), five single-item symptom scores (insomnia, loss of appetite, constipation, diarrhea, and dyspnea), a single item asking about financial difficulties, and global health status/quality of life (QOF) consisting of 2 items. Functional and symptoms scales were measured on a four-point Likert scale, where 1 = not at all and 4 = very much, whereas global health status or QOF was assessed using a 7-item Likert scale, ranging from "poor" (worse quality of life) to "excellent" (better quality of life). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA. |
| Secondary | Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale | From screening until the end of the study (up to 47 months) | EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem\[s\] and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA. A negative adjusted mean change from Baseline represents a worsening of quality of life. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival, as Assessed by the Investigator | From randomization until progression or death (up to 79 months) | Intent-to-Treat (ITT) Population: all participants who were randomized in the study. | Months | MEDIAN |
| PRIMARY | Progression-free Survival, as Assessed by the Independent Review Committee (IRC) | From randomization until progression or death (up to 79 months) | Intent-to-Treat (ITT) Population: all participants who were randomized in the study. | Months | MEDIAN |
| SECONDARY | Overall Survival | From randomization until death (up to 88 months) | ITT Population | Months | MEDIAN |
| SECONDARY | Number of Participants With Improvement in Response From Baseline | From Baseline until the end of the study (up to 88 months) | ITT Population. Only participants who had PR at study entry were analyzed. | Participants | NUMBER |
| SECONDARY | Time to Next Therapy | From randomization until the end of the study (up to 88 months) | ITT Population | Months | MEDIAN |
| SECONDARY | Progression-free Survival After Next-line Therapy | From randomization until progression or death (up to 88 months) | ITT Population. Only participants who received next-line therapy and subjects who died prior to receiving next-line therapy were analyzed. | Months | MEDIAN |
| SECONDARY | Time to Progression After Next-line Therapy | From randomization until progression or death (up to 88 months) | ITT Population. Only participants who received next-line therapy and who also had PD prior to next line therapy were analysed. Participants who died prior to next-line therapy were also included for analysis. | Months | MEDIAN |
| SECONDARY | Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16) | From randomization until the end of the study (up to 47 months) | ITT Population | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score | From randomization until the end of the study (up to 47 months) | ITT Population | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale | From screening until the end of the study (up to 47 months) | ITT Population | Scores on a scale | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group831
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival, as Assessed by the Investigator | Ofatumumab | 34.17 | 95% Confidence Interval 29.70 to 38.01 | Months | |
| Progression-free Survival, as Assessed by the Investigator | Observation | 16.89 | 95% Confidence Interval 12.98 to 20.37 | Months | |
| Progression-free Survival, as Assessed by the Independent Review Committee (IRC) | Ofatumumab | 33.74 | 95% Confidence Interval 28.35 to 38.01 | Months | |
| Progression-free Survival, as Assessed by the Independent Review Committee (IRC) | Observation | 14.98 | 95% Confidence Interval 11.63 to 19.12 | Months | |
| Overall Survival | Ofatumumab | NA | 95% Confidence Interval 68.96 to NA | Months | |
| Overall Survival | Observation | 73.63 | 95% Confidence Interval 66.53 to NA | Months | |
| Number of Participants With Improvement in Response From Baseline | Ofatumumab | 16 | Participants | ||
| Number of Participants With Improvement in Response From Baseline | Observation | 8 | Participants | ||
| Time to Next Therapy | Ofatumumab | 36.21 | 95% Confidence Interval 30.49 to 41.40 | Months | |
| Time to Next Therapy | Observation | 27.56 | 95% Confidence Interval 23.49 to 32.49 | Months |
1 to 10 of 831Source ClinicalTrials.gov
See all 831 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ofatumumab | 240 | |
| Overall Study | STARTED | Observation | 240 | |
| Overall Study | COMPLETED | Ofatumumab | 110 | |
| Overall Study | COMPLETED | Observation | 114 | |
| Overall Study | NOT COMPLETED | Ofatumumab | 130 | |
| Overall Study | NOT COMPLETED | Observation | 126 |
Source ClinicalTrials.gov
Adverse events1,002
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 | 61 | 239 | |
| other | Neutropenia | Blood and lymphatic system disorders | Observation | 22 | 241 | |
| other | Neutropenia | Blood and lymphatic system disorders | Total | 83 | 480 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ofatumumab | 13 | 239 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Observation | 11 | 241 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Total | 24 | 480 | |
| other | Constipation | Gastrointestinal disorders | Ofatumumab | 13 | 239 | |
| other | Constipation | Gastrointestinal disorders | Observation | 11 | 241 | |
| other | Constipation | Gastrointestinal disorders | Total | 24 | 480 | |
| other | Diarrhoea | Gastrointestinal disorders | Ofatumumab | 41 | 239 |
1 to 10 of 1,002Source ClinicalTrials.gov
See all 1,002 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ofatumumab | 88 | 239 |
| Total, all-cause mortality | Observation | 87 | 241 |
| Total, all-cause mortality | Total | 175 | 480 |
| Total, other adverse events | Ofatumumab | 202 | 239 |
| Total, other adverse events | Observation | 139 | 241 |
| Total, other adverse events | Total | 341 | 480 |
| Total, serious adverse events | Ofatumumab | 120 | 239 |
| Total, serious adverse events | Observation | 120 | 241 |
| Total, serious adverse events | Total | 240 | 480 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ofatumumab vs Observation: Number of Participants Who Received at Least One Transfusion During the Study | Trial comparisons |
| Ofatumumab vs Observation: Number of Participants With Improvement in Response From Baseline | Trial comparisons |
| Ofatumumab vs Observation: Number of Participants With Grade 3 and Above Adverse Event of Infection | 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/NCT01039376
GET https://conductscience.org/api/trials/v1/NCT01039376/registered?page=2