BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)

NCT01296932 | Completed Phase 1 Results

• 2 other identifiers: 1270.12010-021488-34
• Study Type: interventional
• Target: 37
• Locations: 3 countries
• Sites: 10

Brief Summary

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

Leukemia, Lymphocytic, Chronic, B-Cell

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Dose-Limiting Toxicities Adverse Events (DLTs)

  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.

  14 days after first administration of BI836826 (MTD evaluation period)

• Maximum Tolerated Dose (MTD)

  The maximum tolerated dose (MTD) was defined as the highest dose of BI 836826 studied for which the incidence of DLT was no more than 17% (i.e. 1 out of 6 patients) during the first treatment cycle. For those patients who received more than 1 cycle of BI 836826, all AEs corresponding to the DLT were considered for the purpose of confirming the MTD and for the selection of the recommended dose for treatment of the expansion cohort and for further development. All DLTs, occurring during the first or repeated treatment cycle were reported as significant AEs. As it was not possible to recruit a sufficient number of patients whilst the first part of the trial was still in progress, the recruitment was ended by the sponsor before the MTD or optimal biological dose (OBD) was reached.

  14 days after first administration of BI836826 (MTD evaluation period)

Secondary Outcomes (7)

• Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood

  baseline and ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days

• Number of Patients With Improved Haemoglobin Count for at Least Two Subsequent Response Assessments

  ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days

• Number of Patients With Improved Platelet Count for at Least Two Subsequent Response Assessments

  ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days

• Number of Patients With Improved Neutrophil Count for at Least Two Subsequent Response Assessments

  ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days

• Best Overall Response According to 'International Workshop on Chronic Lymphocytic Leukemia' (IWCLL) Criteria

  Data collected up to cut-off date 26Oct2016 until Progressive disease (PD) to start of next Chronic Lymphocytic Leukaemia (CLL) therapy, Up to 1809 days.

Study Arms (1)

Patients with relapsed CLL

EXPERIMENTAL

Patients with relapsed CLL after at least two prior treatment regimens will receive BI 836826.

Drug: BI 836826

Interventions

BI 836826 DRUG

Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion.

Patients with relapsed CLL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Prior allogeneic stem cell transplantation.
• Active autoimmune haemolytic anemia.
• Active autoimmune thrombocytopenia.
• Known transformation to an aggressive B-cell malignancy.
• Concurrent treatment with relevant doses of systemic glucocorticosteroids.
• Prior history of malignancy other than chronic lymphocytic leukaemia (exceptions to this rule are defined in the clinical trial protocol).
• Aspartate aminotransferase or alanine aminotransferase \> 2.5 x upper limit of normal.
• Total bilirubin \> 1.5 x upper limit of normal.
• Absolute Neutrophil Count \< 1.000/µl.
• Platelets \< 25.000/µL.
• Estimated Glomerular Filtration Rate \<45 mL/min.
• Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher.
• Significant concurrent disease.
• Any infectious disease requiring treatment at the time of enrolment or within the previous 2 weeks.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (10)

Brussels - UNIV Saint-Luc

Brussels, 1200, Belgium

Location

Edegem - UNIV UZ Antwerpen

Edegem, 2650, Belgium

Location

UNIV UZ Gent

Ghent, 9000, Belgium

Location

INS Paoli-Calmettes

Marseille, 13273, France

Location

CTR Investigation Clinique, onco, Montpellier

Montpellier, 34295, France

Location

INS Universitaire du Cancer

Toulouse, 31059, France

Location

Universitätsklinikum Köln (AöR)

Cologne, 50937, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

BI 836826

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The trial was discontinued due to lack of recruitment before a formal maximum tolerated dose (MTD) was established based on the number of patients with Dose Limiting Toxicities (DLTs) in the first treatment cycle.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 16, 2011
• Study Start: February 11, 2011
• Primary Completion: May 30, 2017
• Study Completion: July 10, 2017
• Last Updated: August 20, 2020
• Results First Posted: August 20, 2020

Record last verified: 2020-08

Locations

DE (4); FR (3); BE (3)