18 and older, any sex, with Lymphoma, Large B-Cell, Diffuse. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period- Phase 1bPrimary· 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 growt
Group
Value
95% CI
BI 836826 25 Milligram (mg) + GemOx
0
BI 836826 50 mg + GemOx
1
BI 836826 100 mg + GemOx
1
Overall Response Based on Investigator's Assessment- Phase 1bSecondary· 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
CR
Group
Value
95% CI
BI 836826 25 Milligram (mg) + GemOx
1
BI 836826 50 mg + GemOx
0
BI 836826 100 mg + GemOx
1
PR
Group
Value
95% CI
BI 836826 25 Milligram (mg) + GemOx
2
BI 836826 50 mg + GemOx
3
BI 836826 100 mg + GemOx
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events that started from the first administration of any trial medication to 30 days after the last administration; up to 114 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part 1 (Phase Ib)
Primary objective:
To establish the maximum tolerated dose (MTD) of BI 836826 in combination with GemOx.
Secondary objectives:
To evaluate pharmacokinetics of BI 836826 when given in combination with GemOx and to investigate preliminary efficacy in terms of the overall response rate based on investigator's assessment.
Part 2 (Phase II randomized)
Primary objective:
To investigate the efficacy by means of the overall response rate (PR+ CR) based on central review assessment in patients with relapsed DLBCL treated with BI 836826-GemOx compared to R-GemOx.
Secondary objective:
To investigate the efficacy by means of the complete remission rate based on central review assessment in patients with relapsed DLBCL treated with BI 836826-GemOx compared to Rituximab + gemcitabine + oxaliplatin (RGemOx).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03343678 — This Study in Patients With Chronic Lymphocytic Leukaemia is Done to Determine a Safe and Effective Dose of BI 836826 in
· Phase 1
· withdrawn
NCT02759016 — Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With a
· Phase 1
· completed
NCT02538614 — Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia
· Phase 1
· terminated
NCT01403948 — BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 17 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02624492.