Trial · NCT02165397
Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia
NCT02165397, Phase 3, Completed, Pharmacyclics LLC.; results first posted 2020-11-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia. Trials, record NCT02165397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02165397
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia
- NCT number
- NCT02165397
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 181 participants, actual
- Lead sponsor
- Pharmacyclics LLC.
- Conditions
- Waldenström's Macroglobulinemia
- Interventions
- Ibrutinib, Placebo, Rituximab
- First posted
- 2014-06-17
- Last updated
- 2021-03-03
- Results first posted
- 2020-11-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54 | Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr]) | PFS was defined as the time from date randomization to date of first IRC-confirmed disease progression (PD) assessed according to the modified VIth International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria (National Comprehensive Cancer Network \[NCCN\] 2014) or death due to any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. As the median PFS was not reached in the Ibrutinib + Rituximab arm at the time of the analysis, Kaplan Meier landmark estimate of the PFS rate at 54 months (that is, the estimated percentage of participants with PFS at Month 54) is presented. |
| Secondary | Overall Response Rate (ORR) Based on IRC Assessment Up to 3 Years After Last Participant Randomized | Median time on study: 49.7 months (Ibr+R and Pbo+R) and 57.9 months (Open-Label Ibr) | ORR, defined as the percentage of participants achieving a best overall response of protocol-specified complete response (CR), very good partial response (VGPR), or partial response (PR) per the IRC assessment at or prior to initiation of subsequent antineoplastic therapy and confirmed by 2 consecutive assessments. IRC assessment of response was conducted according to the modified VIth IWWM (NCCN 2014) criteria and incorporated assessments from the central radiology review. CR required complete resolution of lymphadenopathy/splenomegaly if present at baseline. VGPR and PR required reduction in lymphadenopathy/splenomegaly if present at baseline.. Kaplan-Meier estimate. |
| Secondary | Time to Next Treatment (TnT) Time From the Date of Randomization to the Start Date of Any Subsequent WM Treatment. | Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr]) | TTnT was measured from the date of randomization to the start date of any subsequent WM treatment. Participants without subsequent treatment were censored at the date of the last study visit. As the median TTnT was not reached in the Ibrutinib + Rituximab arm and the Open-Label Substudy arm at the time of the analysis, Kaplan Meier landmark estimate of the TTnT rate at 54 months (that is, the estimated percentage of participants not receiving subsequent WM treatment at Month 54) are presented. |
| Secondary | Percentage of Participants With Sustained Hemoglobin (Hgb) Improvement Up to 3 Years After Last Participant Randomized | Median time on study: 49.7 months (Ibr+R and Pbo+R) and 57.9 months (Open-Label Ibr) | Percentage of participants achieving a sustained improvement in Hgb at or prior to initiation of subsequent antineoplastic therapy. Hgb improvement is defined as an increase of ≥ 2 g/dL over baseline regardless of baseline value, or an increase to \>11 g/dL with a ≥0.5 g/dL improvement if baseline is ≤ 11 g/dL. Sustained Hgb improvement is defined as improvement that is sustained continuously for ≥ 56 days (8 weeks) without blood transfusion or growth factors, which includes hemoglobin \> 110 g/L with at least a 5 g/L improvement if baseline ≤110 g/L or increase ≥20 g/L over baseline. |
| Secondary | Percentage of Participants With ≥ 3 Points Increase From Baseline by Week 25 in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Subscale Score | Baseline, 25 weeks | Percentage of participants with ≥ 3 points increase from baseline by Week 25 in the FACIT-Fatigue subscale score.The FACIT-Fatigue is a 13-item questionnaire that assesses participant reported fatigue and its impact upon daily activities and function over the past 7 days. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total scores from 0 (extreme fatigue) to 52 (no fatigue). Scores below 30 indicate severe fatigue. |
| Secondary | Overall Survival (OS) - Kaplan Meier Landmark Estimates at Month 54 | Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr]) | OS, defined as the time from the date of randomization to the date of death from any cause. All deaths observed as the time of the analysis were considered as events. For participants who were not known to have died at the time of the analysis, OS data were censored at the date last known alive. As the median OS was not reached in any treatment arm at the time of the analysis, Kaplan Meier point estimates of the OS rate (that is, the estimated percentage of participants still surviving at Month 54) are presented. |
Source ClinicalTrials.gov
Outcomes6
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) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54 | Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr]) | Intent to Treat population: all randomized/enrolled participants | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) Based on IRC Assessment Up to 3 Years After Last Participant Randomized | Median time on study: 49.7 months (Ibr+R and Pbo+R) and 57.9 months (Open-Label Ibr) | Intent to Treat population: all randomized/enrolled participants | percentage of participants | NUMBER |
| SECONDARY | Time to Next Treatment (TnT) Time From the Date of Randomization to the Start Date of Any Subsequent WM Treatment. | Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr]) | Intent to Treat population: all randomized/enrolled participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Hemoglobin (Hgb) Improvement Up to 3 Years After Last Participant Randomized | Median time on study: 49.7 months (Ibr+R and Pbo+R) and 57.9 months (Open-Label Ibr) | Intent to Treat population: all randomized/enrolled participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥ 3 Points Increase From Baseline by Week 25 in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Subscale Score | Baseline, 25 weeks | Intent to Treat population: all randomized/enrolled participants | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) - Kaplan Meier Landmark Estimates at Month 54 | Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr]) | Intent to Treat population: all randomized/enrolled participants | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
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) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54 | Ibrutinib + Rituximab | 68.0 | 95% Confidence Interval 54.8 to 78.1 | percentage of participants | |
| Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54 | Placebo + Rituximab | 25.3 | 95% Confidence Interval 15.3 to 36.6 | percentage of participants | |
| Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54 | Open-Label Substudy: Ibrutinib | 39.7 | 95% Confidence Interval 22.3 to 56.7 | percentage of participants | |
| Overall Response Rate (ORR) Based on IRC Assessment Up to 3 Years After Last Participant Randomized | Ibrutinib + Rituximab | 76.0 | percentage of participants | ||
| Overall Response Rate (ORR) Based on IRC Assessment Up to 3 Years After Last Participant Randomized | Placebo + Rituximab | 30.7 | percentage of participants | ||
| Overall Response Rate (ORR) Based on IRC Assessment Up to 3 Years After Last Participant Randomized | Open-Label Substudy: Ibrutinib | 77.4 | percentage of participants | ||
| Time to Next Treatment (TnT) Time From the Date of Randomization to the Start Date of Any Subsequent WM Treatment. | Ibrutinib + Rituximab | 87.4 | 95% Confidence Interval 77.2 to 93.3 | percentage of participants | |
| Time to Next Treatment (TnT) Time From the Date of Randomization to the Start Date of Any Subsequent WM Treatment. | Placebo + Rituximab | 29.4 | 95% Confidence Interval 18.2 to 41.6 | percentage of participants | |
| Time to Next Treatment (TnT) Time From the Date of Randomization to the Start Date of Any Subsequent WM Treatment. | Open-Label Substudy: Ibrutinib | 64.6 | 95% Confidence Interval 44.1 to 79.2 | percentage of participants | |
| Percentage of Participants With Sustained Hemoglobin (Hgb) Improvement Up to 3 Years After Last Participant Randomized | Ibrutinib + Rituximab | 77.3 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibrutinib + Rituximab | 75 | |
| Overall Study | STARTED | Placebo + Rituximab | 75 | |
| Overall Study | STARTED | Open-Label Substudy: Ibrutinib | 31 | |
| Overall Study | COMPLETED | Ibrutinib + Rituximab | 61 | |
| Overall Study | COMPLETED | Placebo + Rituximab | 56 | |
| Overall Study | COMPLETED | Open-Label Substudy: Ibrutinib | 21 | |
| Overall Study | NOT COMPLETED | Ibrutinib + Rituximab | 14 | |
| Overall Study | NOT COMPLETED | Placebo + Rituximab | 19 | |
| Overall Study | NOT COMPLETED | Open-Label Substudy: Ibrutinib | 10 |
Source ClinicalTrials.gov
Adverse events672
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 | Ibrutinib + Rituximab | 17 | 75 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Rituximab | 21 | 75 | |
| other | Anaemia | Blood and lymphatic system disorders | Open-Label Substudy: Ibrutinib | 5 | 31 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Ibrutinib + Rituximab | 9 | 75 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Placebo + Rituximab | 2 | 75 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Open-Label Substudy: Ibrutinib | 8 | 31 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ibrutinib + Rituximab | 0 | 75 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo + Rituximab | 0 | 75 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Open-Label Substudy: Ibrutinib | 2 | 31 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ibrutinib + Rituximab | 12 | 75 |
1 to 10 of 672Source ClinicalTrials.gov
See all 672 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibrutinib + Rituximab | 9 | 75 |
| Total, all-cause mortality | Placebo + Rituximab | 10 | 75 |
| Total, all-cause mortality | Open-Label Substudy: Ibrutinib | 8 | 31 |
| Total, other adverse events | Ibrutinib + Rituximab | 75 | 75 |
| Total, other adverse events | Placebo + Rituximab | 75 | 75 |
| Total, other adverse events | Open-Label Substudy: Ibrutinib | 30 | 31 |
| Total, serious adverse events | Ibrutinib + Rituximab | 40 | 75 |
| Total, serious adverse events | Placebo + Rituximab | 25 | 75 |
| Total, serious adverse events | Open-Label Substudy: Ibrutinib | 16 | 31 |
Source ClinicalTrials.gov
Papers6
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 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/NCT02165397
GET https://conductscience.org/api/trials/v1/NCT02165397/events?page=2