Trial · NCT02624492
To Determine the Dose of BI 836826-GemOx and the Efficacy of BI 836826-GemOx Versus R-GemOx in Patients With Relapsed/Refractory DLBCL
NCT02624492, Phase 2, Completed, Boehringer Ingelheim; results first posted 2019-06-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Determine the Dose of BI 836826-GemOx and the Efficacy of BI 836826-GemOx Versus R-GemOx in Patients With Relapsed/Refractory DLBCL. Trials, record NCT02624492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02624492
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Determine the Dose of BI 836826-GemOx and the Efficacy of BI 836826-GemOx Versus R-GemOx in Patients With Relapsed/Refractory DLBCL
- NCT number
- NCT02624492
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Interventions
- BI 836826, GemOx, Rituximab, GemOx
- First posted
- 2015-12-08
- Last updated
- 2019-06-17
- Other registries' IDs
- eudract:2014-004794-16
- Results first posted
- 2019-06-17
- Limitations and caveats
- Because of discontinuation of BI 836826 programme, Phase II of the trial and PK analysis in Phase Ib were not conducted.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period- Phase 1b | 14 days from first trial medication | DLT definition included both non-haematologic and haematologic drug-related Adverse events (AEs). Non-haematologic AEs of Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 or higher qualified for DLTs with the following exceptions: laboratory abnormalities that could be corrected with treatment within 48 h; nausea, vomiting, or diarrhoea which resolved within 48 h with adequate treatment; neuropathy considered related to oxaliplatin; or an infusion-related reactions (IRR). For haematologic AEs, the following were considered DLTs: Grade 4 neutropenia lasting \>7 days (d) despite growth factors support; any febrile neutropenia which did not resolve within 48 hours with appropriate treatment; Grade 4 thrombocytopenia lasting \>7 d or Grade 3/4 thrombocytopenia with clinically significant bleeding; failure to recover platelets ≥75\*10\^9/litres (L) by 4 weeks after start of the cycle; or failure to recover neutrophils ≥1.0\*10\^9/L by 4 weeks after start of the cycle. |
| Primary | The MTD of BI 836826 With GemOx- Phase 1b | 14 days from first trial medication | MTD defined as the highest dose studied for which the number of patients with dose-limiting toxicity (DLT) was 17% or less (i.e. not more than 1 of 6 patients) during the MTD evaluation period (Cycle 1). |
| Primary | Overall Response, i.e. CR and PR, by Central Review Assessment- Phase II | up to 32 weeks from first trial medication administration | Overall response based on central review assessment, i.e. CR and PR by central review assessment; CR: Disappearance of all evidence of disease PR: Regression of measurable disease and no new sites. Sponsor discontinued the trial for strategic reasons. Consequently, Phase II of the trial was not conducted and hence the endpoint is not evaluated. |
| Secondary | Overall Response Based on Investigator's Assessment- Phase 1b | up to 32 weeks from first trial medication administration. | Overall response based on investigator's assessment, i.e. partial remission (PR) and complete remission (CR) by investigator assessment; CR: Disappearance of all evidence of disease PR: Regression of measurable disease and no new sites |
| Secondary | Area Under the Plasma Concentration-time Curve Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point After Drug Administration (AUC0-tz) of BI 836826- Phase 1b | up to 32 weeks from first trial medication administration. | Pharmacokinetic (PK) analyses were planned to be performed. However, after encountering technical difficulties and discontinuation of the BI 836826 programme, the sponsor decided not to re-analyse the samples. |
| Secondary | Maximum Measured Plasma Concentration of BI 836826 (Cmax)- Phase 1b | up to 32 weeks from first trial medication administration. | Pharmacokinetic analyses were planned to be performed. However, after encountering technical difficulties and discontinuation of the BI 836826 programme, the sponsor decided not to re-analyse the samples. |
| Secondary | Complete Response (CR) by Central Review Assessment- Phase II | up to 32 weeks from first trial medication administration. | Complete Response (CR) by central review assessment- Phase II; CR: Disappearance of all evidence of disease. Sponsor discontinued the trial for strategic reasons. Consequently, Phase II of the trial was not conducted and hence the endpoint is not evaluated. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period- Phase 1b | 14 days from first trial medication | MTD evaluation set: The MTD evaluation set includes all patients who were documented to have received at least 1 dose of BI 836826 and were not replaced for the MTD evaluation. | participants | NUMBER |
| PRIMARY | The MTD of BI 836826 With GemOx- Phase 1b | 14 days from first trial medication | The trial was discontinued prematurely before the MTD based on the frequency of patients with DLTs in the MTD evaluation period, i.e. the 1st treatment cycle, was reached. | ||
| SECONDARY | Overall Response Based on Investigator's Assessment- Phase 1b | up to 32 weeks from first trial medication administration. | Treated set | participants | NUMBER |
| SECONDARY | Area Under the Plasma Concentration-time Curve Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point After Drug Administration (AUC0-tz) of BI 836826- Phase 1b | up to 32 weeks from first trial medication administration. | PK parameters were not calculated because the sponsor discontinued development of BI 836826 | ||
| SECONDARY | Maximum Measured Plasma Concentration of BI 836826 (Cmax)- Phase 1b | up to 32 weeks from first trial medication administration. | PK parameters were not calculated because the sponsor discontinued development of BI 836826 | ||
| SECONDARY | Complete Response (CR) by Central Review Assessment- Phase II | up to 32 weeks from first trial medication administration. | Primary and secondary endpoints of Phase II are not applicable (NA) since Phase II has not been conducted | ||
| PRIMARY | Overall Response, i.e. CR and PR, by Central Review Assessment- Phase II | up to 32 weeks from first trial medication administration | Primary and secondary endpoints of Phase II are not applicable (NA) since Phase II has not been conducted |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period- Phase 1b | BI 836826 25 Milligram (mg) + GemOx | 0 | participants | ||
| Number of Patients With Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period- Phase 1b | BI 836826 50 mg + GemOx | 1 | participants | ||
| Number of Patients With Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period- Phase 1b | BI 836826 100 mg + GemOx | 1 | participants | ||
| Overall Response Based on Investigator's Assessment- Phase 1b | BI 836826 25 Milligram (mg) + GemOx | CR | 1 | participants | |
| Overall Response Based on Investigator's Assessment- Phase 1b | BI 836826 50 mg + GemOx | CR | 0 | participants | |
| Overall Response Based on Investigator's Assessment- Phase 1b | BI 836826 100 mg + GemOx | CR | 1 | participants | |
| Overall Response Based on Investigator's Assessment- Phase 1b | BI 836826 25 Milligram (mg) + GemOx | PR | 2 | participants | |
| Overall Response Based on Investigator's Assessment- Phase 1b | BI 836826 50 mg + GemOx | PR | 3 | participants | |
| Overall Response Based on Investigator's Assessment- Phase 1b | BI 836826 100 mg + GemOx | PR | 1 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BI 836826 25 Milligram (mg) + GemOx | 5 | |
| Overall Study | STARTED | BI 836826 50 mg + GemOx | 8 | |
| Overall Study | STARTED | BI 836826 100 mg + GemOx | 8 | |
| Overall Study | COMPLETED | BI 836826 25 Milligram (mg) + GemOx | 3 | |
| Overall Study | COMPLETED | BI 836826 50 mg + GemOx | 4 | |
| Overall Study | COMPLETED | BI 836826 100 mg + GemOx | 3 | |
| Overall Study | NOT COMPLETED | BI 836826 25 Milligram (mg) + GemOx | 2 | |
| Overall Study | NOT COMPLETED | BI 836826 50 mg + GemOx | 4 | |
| Overall Study | NOT COMPLETED | BI 836826 100 mg + GemOx | 5 |
Source ClinicalTrials.gov
Adverse events255
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 | BI 836826 25 Milligram (mg) + GemOx | 3 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 50 mg + GemOx | 4 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 100 mg + GemOx | 7 | 8 | |
| other | Leukocytosis | Blood and lymphatic system disorders | BI 836826 25 Milligram (mg) + GemOx | 1 | 5 | |
| other | Leukocytosis | Blood and lymphatic system disorders | BI 836826 50 mg + GemOx | 0 | 8 | |
| other | Leukocytosis | Blood and lymphatic system disorders | BI 836826 100 mg + GemOx | 0 | 8 | |
| other | Leukopenia | Blood and lymphatic system disorders | BI 836826 25 Milligram (mg) + GemOx | 1 | 5 | |
| other | Leukopenia | Blood and lymphatic system disorders | BI 836826 50 mg + GemOx | 0 | 8 | |
| other | Leukopenia | Blood and lymphatic system disorders | BI 836826 100 mg + GemOx | 1 | 8 | |
| other | Lymphopenia | Blood and lymphatic system disorders | BI 836826 25 Milligram (mg) + GemOx | 0 | 5 |
1 to 10 of 255Source ClinicalTrials.gov
See all 255 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BI 836826 25 Milligram (mg) + GemOx | 0 | 5 |
| Total, all-cause mortality | BI 836826 50 mg + GemOx | 2 | 8 |
| Total, all-cause mortality | BI 836826 100 mg + GemOx | 1 | 8 |
| Total, other adverse events | BI 836826 25 Milligram (mg) + GemOx | 5 | 5 |
| Total, other adverse events | BI 836826 50 mg + GemOx | 8 | 8 |
| Total, other adverse events | BI 836826 100 mg + GemOx | 8 | 8 |
| Total, serious adverse events | BI 836826 25 Milligram (mg) + GemOx | 4 | 5 |
| Total, serious adverse events | BI 836826 50 mg + GemOx | 5 | 8 |
| Total, serious adverse events | BI 836826 100 mg + GemOx | 3 | 8 |
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 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/NCT02624492
GET https://conductscience.org/api/trials/v1/NCT02624492/events?page=2