BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01296932
First received: February 15, 2011
Last updated: July 9, 2014
Last verified: July 2014

February 15, 2011
July 9, 2014
February 2011
March 2015   (final data collection date for primary outcome measure)
Determination of the maximum tolerated dose of BI 836826 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01296932 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)
A Phase I, Open, Dose Escalation Trial With BI 836826 in Patients With Advanced Chronic Lymphocytic Leukaemia

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Lymphocytic, Chronic, B-Cell
Drug: BI 836826
Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion.
Experimental: Patients with relapsed CLL
Patients with relapsed CLL after at least two prior treatment regimens will receive BI 836826.
Intervention: Drug: BI 836826
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Belgium,   France,   Germany
 
NCT01296932
1270.1, 2010-021488-34
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP