To Determine the Dose of BI 836826-GemOx and the Efficacy of BI 836826-GemOx Versus R-GemOx in Patients With Relapsed/Refractory DLBCL
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Interventions
- Registration Number
- NCT02624492
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description R-GemOx GemOx - BI 836826-GemOx GemOx - BI 836826-GemOx BI 836826 - R-GemOx Rituximab -
- Primary Outcome Measures
Name Time Method 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.
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.
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).
- Secondary Outcome Measures
Name Time Method 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
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.
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.
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.
Trial Locations
- Locations (7)
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Jessa Ziekenhuis - Campus Virga Jesse
🇧🇪Hasselt, Belgium
A. O. S. Maria della Misericordia
🇮🇹Udine, Italy
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Italy