A Phase I, Open-Label, Dose-Escalation Trial With BI 836826 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma of B Cell Origin
Overview
- Phase
- Phase 1
- Intervention
- BI 836826
- Conditions
- Lymphoma, Non-Hodgkin
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 48
- Locations
- 12
- Primary Endpoint
- Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma with at least prior treatments.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Patients with relapsed or refractory NHL
Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments
Intervention: BI 836826
Outcomes
Primary Outcomes
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
Time Frame: From the first administration of trial medication to 7 days after the second administration, upto 36 days
The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients. The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course. In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration.. A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826.
Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients
Time Frame: From the first administration of trial medication to 7 days after the second administration, up to 36 days
Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL).
Secondary Outcomes
- Tumour Size Reduction(Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.)
- Best Overall Response Based on All Assessment(Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT))
- Best Overall Response Based on Imaging Data(Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.)
- Progression Free Survival (PFS)(from first treatment until disease progression or death from any cause, up to 12 months.)
- Failure Free Survival (FFS)(from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.)