Trial · NCT01980628
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
NCT01980628, Phase 2, Completed, Pharmacyclics LLC.; results first posted 2017-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma. Trials, record NCT01980628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01980628
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
- NCT number
- NCT01980628
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- Pharmacyclics LLC.
- Conditions
- Marginal Zone Lymphoma, B-cell Lymphoma
- Interventions
- ibrutinib
- First posted
- 2013-11-11
- Last updated
- 2019-10-16
- Results first posted
- 2017-02-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR (Overall Response Rate) | Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months. | ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review committee (IRC). Per Cheson: CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites. |
| Secondary | DOR (Duration of Response) | Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months. | The DOR analyses is performed on the subset of subjects that achieve CR or PR as determined by IRC. DOR is calculated as the duration of time from the date of first response to the date of progression or death due to any cause. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | ORR (Overall Response Rate) | Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months. | Percentage of Participants | MEAN | |
| SECONDARY | DOR (Duration of Response) | Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| ORR (Overall Response Rate) | Single Arm, Intent to Treat Population | 46 | 95% Confidence Interval 33.5 to 59.3 | Percentage of Participants | |
| DOR (Duration of Response) | Ibrutinib | NA | 95% Confidence Interval 16.7 to NA | Months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibrutinib | 63 | |
| Overall Study | COMPLETED | Ibrutinib | 0 | |
| Overall Study | NOT COMPLETED | Ibrutinib | 63 |
Source ClinicalTrials.gov
Adverse events123
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 | 23 | 63 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ibrutinib | 15 | 63 | |
| other | Increased Tendency To Bruise | Blood and lymphatic system disorders | Ibrutinib | 12 | 63 | |
| other | Atrial Fibrillation | Cardiac disorders | Ibrutinib | 5 | 63 | |
| other | Vision Blurred | Eye disorders | Ibrutinib | 4 | 63 | |
| other | Diarrhoea | Gastrointestinal disorders | Ibrutinib | 30 | 63 | |
| other | Nausea | Gastrointestinal disorders | Ibrutinib | 20 | 63 | |
| other | Dyspepsia | Gastrointestinal disorders | Ibrutinib | 12 | 63 | |
| other | Abdominal Pain | Gastrointestinal disorders | Ibrutinib | 10 | 63 | |
| other | Constipation | Gastrointestinal disorders | Ibrutinib | 10 | 63 |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibrutinib | 17 | 63 |
| Total, other adverse events | Ibrutinib | 63 | 63 |
| Total, serious adverse events | Ibrutinib | 29 | 63 |
Source ClinicalTrials.gov
Papers2
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/NCT01980628
GET https://conductscience.org/api/trials/v1/NCT01980628/events?page=2