BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01296932
First received: February 15, 2011
Last updated: August 20, 2014
Last verified: August 2014
  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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence and intensity of adverse events graded according to CTCAE [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of dose limiting toxicity (DLT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Assessment of safety laboratory parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of lymphocytes in the peripheral blood [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Tumour size [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Blood counts [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Best overall response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Failure free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (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
Genders Eligible for Study:   Both
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 other antileukemia therapy within 2 weeks 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

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Belgium
1270.1.32001 Boehringer Ingelheim Investigational Site Recruiting
Bruxelles, Belgium
1270.1.32005 Boehringer Ingelheim Investigational Site Recruiting
Edegem, Belgium
1270.1.32003 Boehringer Ingelheim Investigational Site Recruiting
Gent, Belgium
1270.1.32004 Boehringer Ingelheim Investigational Site Recruiting
Yvoir, Belgium
France
1270.1.33002 Boehringer Ingelheim Investigational Site Recruiting
Marseille Cedex 09, France
1270.1.33001 Boehringer Ingelheim Investigational Site Recruiting
Montpellier Cedex 5, France
1270.1.33003 Boehringer Ingelheim Investigational Site Recruiting
Toulouse Cedex 9, France
Germany
1270.1.49005 Boehringer Ingelheim Investigational Site Recruiting
Berlin, Germany
1270.1.49004 Boehringer Ingelheim Investigational Site Recruiting
Frankfurt am Main, Germany
1270.1.49003 Boehringer Ingelheim Investigational Site Recruiting
Heidelberg, Germany
1270.1.49002 Boehringer Ingelheim Investigational Site Recruiting
Köln, Germany
1270.1.49001 Boehringer Ingelheim Investigational Site Recruiting
Ulm, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01296932     History of Changes
Other Study ID Numbers: 1270.1, 2010-021488-34
Study First Received: February 15, 2011
Last Updated: August 20, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
France: Agence Nationale sécurité médicament et des produits santé
Germany: Paul-Ehrlich-Institute
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014