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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02759016
Recruitment Status : Active, not recruiting
First Posted : May 3, 2016
Last Update Posted : April 24, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Chronic, B-Cell Drug: BI 836826 Drug: Ibrutinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 23, 2016
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Ibrutinib

Arm Intervention/treatment
Experimental: BI 836826
BI 836826 administered in combination with Standard of Care Ibrutinib
Drug: BI 836826
Drug: Ibrutinib
Standard of Care

Primary Outcome Measures :
  1. Recommended phase 2 dose of BI 836826 in combination with ibrutinib [ Time Frame: Up to 1 year ]
  2. Number of patients with Dose Limiting Toxicities (DLTs) during the first treatment cycle [ Time Frame: Up to 4 weeks ]

Secondary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: Up to 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Diagnosis of Chronic Lymphocytic Leukemia (CLL) established according to International Workshop Chronic Lymphocytic Leukemia (IWCLL) criteria.
  • Relapsed or refractory CLL pre-treated with at least one prior line of systemic therapy for CLL.
  • Indication for treatment consistent with IWCLL criteria, i.e. at least one of the following criteria should be met
  • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia.
  • Massive or progressive or symptomatic splenomegaly.
  • Massive nodes or progressive or symptomatic lymphadenopathy.
  • Progressive lymphocytosis in the absence of infection, with an increase in blood Absolute Lymphocyte Count (ALC) >=50% over a 2-month period, or a lymphocyte doubling time (LDT) of <6 months (as long as initial ALC was >=30000/µl).
  • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy.
  • Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs:
  • unintentional weight loss of 10% or more within the previous 6 months
  • significant fatigue
  • fevers higher than 100.5°F or 38.0°C for >=2 weeks without other evidence of infection
  • night sweats for > 1 month without evidence of infection
  • Clinically quantifiable disease burden defined as at least one of the following:
  • either ALC >10 000/µL, or
  • measurable lymphadenopathy
  • quantifiable bone marrow infiltration documented in a bone marrow biopsy during screening
  • Resolution of all clinically relevant acute non-hematologic toxic effects of any prior antitumor therapy resolved to Grade <=1
  • Baseline laboratory data as defined as:

Hemoglobin (Hb): >=8g/dL Absolute Neutrophil Count (ANC): >=1000/µL Platelet (PLT): >=25000/µL Glomerular Filtration Rate (GFR) or Creatinine Clearance: >=30ml/min Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): <3 x Upper Limit of Normal (ULN) Bilirubin - total: <1.5 x ULN Activated Partial Thromboplastin Time (aPTT), Prothrombin Time (PT) or International Normalized Ratio (INR): <=1.5 x ULN PT <=1.5 x ULN, INR <=1.5

  • Male or female patients. Women of childbearing potential must agree to use highly effective methods of birth control during the trial and for at least 1 year after the last dose of BI 836826 and 1 month after the last dose of ibrutinib.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
  • Age 18 years and older
  • Eligible and able to secure sourcing for ibrutinib
  • Written Informed Consent
  • Further Inclusion criteria apply

Exclusion criteria:

  • Known transformation of Chronic Lymphocytic Leukemia (CLL) to an aggressive B-cell malignancy at the time of screening
  • Prior allogeneic stem cell transplant within one year or active graft vs. host disease.
  • History of a non-CLL malignancy except for adequately treated in situ, stage 1 or 2 carcinoma in Complete Response (CR), or any other cancer that has been in CR for >=2 years after end of cancer treatment.
  • Active, uncontrolled autoimmune cytopenia. Patients with autoimmune cytopenia which is controlled with corticosteroids at doses of <=20 mg prednisolone or equivalent may be enrolled.
  • Previous CLL treatment with a CD37-targeting antibody or a CD37-antibody drug conjugate.
  • Previous treatment with ibrutinib
  • Previous treatment with another Bruton's Tyrosine Kinase (BTK) -inhibitor.
  • Ongoing systemic immunosuppressive therapy other than corticosteroids.
  • Active bacterial, viral, or fungal infection requiring systemic treatment at the time of study entry.
  • Human Immunodeficiency Virus (HIV) infection
  • Active hepatitis B or C as evidenced by detection of virus specific Deoxyribonucleic Acid (DNA) or Ribonucleic Acid (RNA).
  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment
  • Chronic persistent atrial flutter or atrial fibrillation. Patients with intermittent atrial fibrillation may be enrolled if without episode for >= 6 months and without indication for anti-coagulation
  • Requirement for chronic anticoagulation with warfarin or with direct oral anticoagulants at the time of screening.
  • Chronic treatment (i.e. >7 days) with a strong Cytochrome P450 (CYP3A) inhibitor which cannot be terminated prior to the first dose of ibrutinib.
  • Unstable angina pectoris, uncontrolled hypertension, uncontrolled asthma or other pulmonary disease
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial
  • Further Exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02759016

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United States, California
City of Hope
Duarte, California, United States, 91010
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim Identifier: NCT02759016     History of Changes
Other Study ID Numbers: 1270.15
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
BI 836826
Antineoplastic Agents, Immunological
Antineoplastic Agents