Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With at Least One Prior Line of Systemic Therapy, and Who Are Eligible for Treatment With Ibrutinib

Part of paid clinical trials in Duarte, California.

Sponsor
Boehringer Ingelheim
Study ID
NCT02759016
Phase
PHASE1
Status
Completed

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • BI 836826 — DRUG
  • Ibrutinib — DRUG
    Standard of Care

Study Details

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

Key Dates

Start date
Jun 23, 2016
Status verified
Sep 2020
Primary completion
Jun 3, 2019
Completion
Jul 9, 2019

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BI 836826
    BI 836826 administered in combination with Standard of Care Ibrutinib

Primary Outcome Measure

Recommended Phase 2 Dose of BI 836826 in Combination With Ibrutinib [ Time Frame: First treatment cycle, 4 weeks from first administration of BI 836826. ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Oregon Health and Sciences UniversityPortlandOregon97239-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CADana-Farber Cancer Institute· Boston, MAOregon Health and Sciences University· Portland, OR

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