Trial · NCT02759016
Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With at Least One Prior Line of Systemic Therapy, and Who Are Eligible for Treatment With Ibrutinib
NCT02759016, Phase 1, Completed, Boehringer Ingelheim; results first posted 2020-07-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With at Least One Prior Line of Systemic Therapy, and Who Are Eligible for Treatment With Ibrutinib. Trials, record NCT02759016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02759016
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With at Least One Prior Line of Systemic Therapy, and Who Are Eligible for Treatment With Ibrutinib
- NCT number
- NCT02759016
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 7 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Interventions
- BI 836826, Ibrutinib
- First posted
- 2016-05-03
- Last updated
- 2020-09-29
- Results first posted
- 2020-07-24
- Limitations and caveats
Development of BI 836826 was discontinued (strategic decision). Recruitment was subsequently terminated, the Phase II part of the trial was eliminated from the protocol, participants on treatment were allowed to complete the trial as per protocol.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase 2 Dose of BI 836826 in Combination With Ibrutinib | First treatment cycle, 4 weeks from first administration of BI 836826. | The Recommended Phase 2 Dose (RP2D ) of BI 836826 in combination with ibrutinib would be either the Maximum Tolerated Dose (MTD) or a lower dose and would be determined by the safety review committee based on safety and efficacy considerations. |
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle | First treatment cycle, 4 weeks from first administration of BI 836826. | Number of participants with Dose Limiting Toxicities (DLTs) during the first treatment cycle. DLT was defined as any non-hematologic adverse event (AE) of Grade ≥ 3 related to BI 836826 and/or ibrutinib except infusion-related reaction (any Grade), Grade 3 Aspartate Aminotransferase (AST)- and/or Alanine Aminotransferase (ALT) elevation without concomitant bilirubin, elevation or any other asymptomatic Grade 3 laboratory abnormality with spontaneous recovery within 1 week. The following hematologic AEs related to BI 836826 and/or ibrutinib were considered DLT: Grade 4 neutropenia with concomitant infection, Grade 4 febrile neutropenia, and Grade 3 febrile neutropenia not resolving within 72 hours with appropriate treatment (antibiotics, antivirals, antifungals, growth factor support), Grade 4 thrombocytopenia with clinically significant bleeding, Grade 4 anemia, any Grade 5 hematologic AE. |
| Secondary | Maximum Tolerated Dose of BI 836826 in Combination With Ibrutinib | First treatment cycle, 4 weeks from first administration of BI 836826. | To determine the Maximum Tolerated Dose (MTD) of BI 836826 in combination with ibrutinib, participants were entered sequentially into dose cohorts starting at 100 mg of BI 836826 and escalating to the MTD in combination with ibrutinib (fixed dose of 420 mg daily). Stepwise dose escalation of BI 836826 was guided by a Bayesian Logistic Regression Model (BLRM) with overdose control. The BLRM estimates the MTD by updating estimates of the probability of observing a Dose Limiting Toxicity (DLT) in the first treatment cycle (4 weeks) for each dose level as participant information becomes available. The MTD would be considered reached if the following criteria were fulfilled. The posterior probability of the true DLT rate in the target interval \[0.16 - 0.33) of the MTD is above 0.50 or at least 15 participants have been treated in the study, of which at least 6 at the MTD. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recommended Phase 2 Dose of BI 836826 in Combination With Ibrutinib | First treatment cycle, 4 weeks from first administration of BI 836826. | As the study was prematurely discontinued, recruitment of participants into the dose escalation part was not fully completed, the MTD was not reached and hence the RP2D could not be determined. | ||
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle | First treatment cycle, 4 weeks from first administration of BI 836826. | All participants who were documented to have initiated at least one dose of BI 836826 and were not replaced for the Maximum Tolerated Dose (MTD) evaluation. | Participants | NUMBER |
| SECONDARY | Maximum Tolerated Dose of BI 836826 in Combination With Ibrutinib | First treatment cycle, 4 weeks from first administration of BI 836826. | As the study was prematurely discontinued, recruitment of participants into the dose escalation part was not fully completed and the MTD was not reached. |
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 |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 0 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 4 | |
| Overall Study | STARTED | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 3 | |
| Overall Study | Treated With BI 836826 and Ibrutinib | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 3 | |
| Overall Study | Treated With BI 836826 and Ibrutinib | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 3 | |
| Overall Study | COMPLETED | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 0 | |
| Overall Study | COMPLETED | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 0 | |
| Overall Study | NOT COMPLETED | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 4 | |
| Overall Study | NOT COMPLETED | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 3 |
Source ClinicalTrials.gov
Adverse events134
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 | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 1 | 3 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 1 | 3 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 0 | 3 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 0 | 3 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 2 | 3 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 1 | 3 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 1 | 3 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 1 | 3 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 1 | 3 |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 0 | 3 |
| Total, all-cause mortality | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 0 | 3 |
| Total, other adverse events | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 3 | 3 |
| Total, other adverse events | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 3 | 3 |
| Total, serious adverse events | Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib | 2 | 3 |
| Total, serious adverse events | Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib | 3 | 3 |
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 |
|---|---|
Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib vs Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle | Trial comparisons |
| Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib vs Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib: deaths from any cause | Trial comparisons |
| Dose Cohort BI 836826 100 Milligram (mg) + Ibrutinib vs Dose Cohort BI 836826 200 Milligram (mg) + Ibrutinib: 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/NCT02759016
GET https://conductscience.org/api/trials/v1/NCT02759016/events?page=2