Clinical trial · Interventional

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

NCT01296932CI-TRIAL-00046721completedPhase 1Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia, Lymphocytic, Chronic, B-Cell	Leukemia	ONTOLOGY_EXACT	0.85

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
BI 836826	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Patients with relapsed CLL
description
Patients with relapsed CLL after at least two prior treatment regimens will receive BI 836826.
interventionNames
1. Drug: BI 836826

Primary outcomes (2)

measure
Number of Patients With Dose-Limiting Toxicities Adverse Events (DLTs)
timeFrame
14 days after first administration of BI836826 (MTD evaluation period)
description
Dose-Limiting Toxicities (DLTs) were defined as any drug-related non-haematologic adverse event of Common Terminology Criteria for AE (CTCAE) Grade 3 or higher, except infusion related reactions associated with the administration of BI 836826. In addition complications due to haematologic AEs were considered as DLTs and were added in more detail in an amendment later on.
measure
Maximum Tolerated Dose (MTD)
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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 Cluster of Differentiation (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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Feb 11, 2011
Primary completion: May 30, 2017
Completion: Jul 10, 2017
First posted: Feb 16, 2011
Last update posted: Aug 20, 2020
Results first posted: Aug 20, 2020
Enrollment: 37 (actual)
Lead sponsor: Boehringer Ingelheim INDUSTRY

Data updated 22 days agoSource updated Aug 20, 2020source: clinicaltrials

Locations

Locations by country (10)

Country	Sites	Recruiting
Germany	4	0
Belgium	3	0
France	3	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.