CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 7 enrolled
Drug / intervention
BI 836826 +1 moredrug
Likely dose
BI 836826 (dose to be determined via escalation) plus ibrutinib (standard of care dosing)AI-extracted
Key inclusion· 6
  • ✓Diagnosis of CLL established per IWCLL criteria
  • ✓Relapsed or refractory CLL with at least one prior line of systemic therapy
  • ✓Indication for treatment per IWCLL criteria (progressive marrow failure, splenomegaly, lymphadenopathy, progressive lymphocytosis, autoimmune cytopenias, constitutional symptoms, or quantifiable disease burden)
  • ✓Clinically quantifiable disease burden: ALC >10,000/µL, measurable lymphadenopathy, or bone marrow infiltration on biopsy
Key exclusion· 11
  • ✕Known CLL transformation to aggressive B-cell malignancy
  • ✕Allogeneic stem cell transplant within 1 year or active graft-versus-host disease
  • ✕Active, uncontrolled autoimmune cytopenia (controlled with ≤20 mg prednisolone equivalent allowed)
  • ✕Prior CD37-targeted antibody or CD37-antibody drug conjugate

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02759016
NCT02759016Phase 1Completed
CompareCT.gov

A Phase Ib, Open Label, Single Arm, Multi-center, Dose Escalation Trial of Intravenous BI 836826 in Combination With Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia

Boehringer Ingelheim·interventional·Posted May 3, 2016·Updated Sep 29, 2020

In Brief

A Phase 1 clinical trial evaluating BI 836826 and Ibrutinib for Leukemia, Lymphocytic, Chronic, B-Cell. Completed, enrolled 7 participants across 3 sites.

Detailed Summary

Intravenous BI 836826 in combination with ibrutinib in relapsed/refractory Chronic Lymphocytic Leukemia (CLL) patients who have been pre-treated with at least one prior line of systemic therapy, and who are eligible for treatment with ibrutinib. Objectives of the trial are to determine the recommended Phase 2 dose of BI 836826, and to document the safety and tolerability of BI 836826 when given in combination with ibrutinib

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphocytic, Chronic, B-Cell
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 3, 2016
Enrollment StartJun 23, 2016
Primary CompletionJun 3, 2019
Study CompletionJul 9, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.2 years ago

Interventions

BI 836826drug

Ibrutinibdrug

Standard of Care