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BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01296932
First received: February 15, 2011
Last updated: August 16, 2017
Last verified: August 2017
  Purpose
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: None (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 ]

Enrollment: 37
Actual Study Start Date: February 11, 2011
Study Completion Date: May 30, 2017
Primary Completion Date: May 30, 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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296932

Locations
Belgium
Brussels - UNIV St-Luc
Bruxelles, Belgium, 1200
Edegem - UNIV UZ Antwerpen
Edegem, Belgium, 2650
Gent - UNIV UZ Gent
Gent, Belgium, 9000
France
INS Paoli-Calmettes
Marseille, France, 13273
CTR Investigation Clinique, onco, Montpellier
Montpellier Cedex 5, France, 34295
INS Universitaire du Cancer
Toulouse, France, 31059
Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany, 60590
Uniklinikum Heidelberg
Heidelberg, Germany, 69120
Klinikum Köln, Klinik I für Innere Medizin
Köln, Germany, 50937
Universitätsklinikum Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01296932     History of Changes
Other Study ID Numbers: 1270.1
2010-021488-34 ( EudraCT Number )
Study First Received: February 15, 2011
Last Updated: August 16, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017