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BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: February 15, 2011
Last updated: October 25, 2016
Last verified: October 2016
Adult patients with chronic lymphocytic leukaemia who experience a relapse after at least two prior treatment regimens may be enrolled in this trial. The trial will examine whether monotherapy with BI 836826 is safe and tolerable at escalating dose levels.

Condition Intervention Phase
Leukemia, Lymphocytic, Chronic, B-Cell
Drug: BI 836826
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open, Dose Escalation Trial With BI 836826 in Patients With Advanced Chronic Lymphocytic Leukaemia

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Determination of the maximum tolerated dose of BI 836826 [ Time Frame: 12 months ]
  • Incidence of dose limiting toxicity (DLT) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Number of lymphocytes in the peripheral blood [ Time Frame: 12 months ]
  • Tumour size [ Time Frame: 12 months ]
  • Blood counts [ Time Frame: 12 months ]
  • Best overall response [ Time Frame: 12 months ]
  • Progression free survival [ Time Frame: 12 months ]
  • Failure free survival [ Time Frame: 12 months ]

Estimated Enrollment: 37
Study Start Date: February 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with relapsed CLL
Patients with relapsed CLL after at least two prior treatment regimens will receive BI 836826.
Drug: BI 836826
Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Diagnosis of relapsed or refractory chronic lymphocytic leukaemia.
  2. At least two prior treatment regimens for chronic lymphocytic leukaemia.
  3. At least one criterion for active disease as defined by the International Workshop on CLL.
  4. Absolute lymphocyte count lower than 200 x 10^9/l .
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2.
  6. Age 18 years or older.
  7. Written informed consent which is consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and local legislation.

Exclusion criteria:

  1. Treatment with anti CD 20 therapy within 4 weeks, or alemtuzumab within 8 weeks, or any cytotoxic antileukemia therapy within 2 weeks, Ibrutinib or Idelalisib within 1 week prior to the first administration of the trial drug.
  2. Prior allogeneic stem cell transplantation.
  3. Active autoimmune haemolytic anemia.
  4. Active autoimmune thrombocytopenia.
  5. Known transformation to an aggressive B-cell malignancy.
  6. Concurrent treatment with relevant doses of systemic glucocorticosteroids.
  7. Prior history of malignancy other than chronic lymphocytic leukaemia (exceptions to this rule are defined in the clinical trial protocol).
  8. Aspartate aminotransferase or alanine aminotransferase > 2.5 x upper limit of normal.
  9. Total bilirubin > 1.5 x upper limit of normal.
  10. Absolute Neutrophil Count < 1.000/µl.
  11. Platelets < 25.000/µL.
  12. Estimated Glomerular Filtration Rate <45 mL/min.
  13. Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher.
  14. Significant concurrent disease.
  15. Any infectious disease requiring treatment at the time of enrolment or within the previous 2 weeks.
  16. Hepatitis B or C.
  17. Human Immunodeficiency Virus (HIV) infection.
  18. Cytomegalovirus (CMV) viremia.
  19. Women of childbearing potential not using a highly effective method of birth control during the trial until one year after the last dose.
  20. Pregnancy or breast feeding.
  21. Known or suspected active alcohol or drug abuse.
  22. Treatment with another investigational drug within the past four weeks before start of therapy or concomitantly with this trial.
  23. Prior treatment with BI 836826.
  24. Patients unable to comply with the protocol
  Contacts and Locations
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Please refer to this study by its identifier: NCT01296932

Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
Boehringer Ingelheim Investigational Site
Edegem, Belgium
Boehringer Ingelheim Investigational Site
Gent, Belgium
Boehringer Ingelheim Investigational Site
Marseille Cedex 09, France
Boehringer Ingelheim Investigational Site
Montpellier Cedex 5, France
Boehringer Ingelheim Investigational Site
Toulouse Cedex 9, France
Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
Boehringer Ingelheim Investigational Site
Heidelberg, Germany
Boehringer Ingelheim Investigational Site
Köln, Germany
Boehringer Ingelheim Investigational Site
Ulm, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT01296932     History of Changes
Other Study ID Numbers: 1270.1
2010-021488-34 ( EudraCT Number: EudraCT )
Study First Received: February 15, 2011
Last Updated: October 25, 2016

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell processed this record on May 22, 2017