BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

NCT01403948 | Completed Phase 1 Results

• 2 other identifiers: 1270.22010-024456-29
• Study Type: interventional
• Target: 48
• Locations: 3 countries
• Sites: 12

Brief Summary

The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma with at least prior treatments.

Conditions

Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (2)

• Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients

  The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients. The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course. In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration.. A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826.

  From the first administration of trial medication to 7 days after the second administration, upto 36 days

• Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients

  Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL).

  From the first administration of trial medication to 7 days after the second administration, up to 36 days

Secondary Outcomes (5)

• Tumour Size Reduction

  Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.

• Best Overall Response Based on All Assessment

  Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)

• Best Overall Response Based on Imaging Data

  Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.

• Progression Free Survival (PFS)

  from first treatment until disease progression or death from any cause, up to 12 months.

• Failure Free Survival (FFS)

  from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.

Study Arms (1)

Patients with relapsed or refractory NHL

EXPERIMENTAL

Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments

Drug: BI 836826

Interventions

BI 836826 DRUG

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

Patients with relapsed or refractory NHL

Eligibility Criteria

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

You may qualify if:

• Patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin (mature B cell lymphoma according to WHO) not considered candidates for intensive anti-lymphoma therapy
• Patients must have either aggressive NHL and received at least one prior anti-CD20 containing immunochemotherapy or indolent NHL and received anti-CD20 therapy and at least two prior therapies
• Measurable disease on computed tomography (CT) scan with involvement of one clearly demarcated lesion =2 cm or two or more clearly demarcated lesions of \>1.5 cm at longest diameter (this criterion applies only for the expansion cohort)
• Relapse or progression of disease with an indication for therapy as per investigator's judgement
• Life expectancy of =3 months
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

You may not qualify if:

• Primary central nervous system (CNS) lymphoma or known CNS involvement
• Prior history of malignancy other than a mature B cell neoplasm according to WHO classification (except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the uterine cervix or breast treated with curative therapy) unless the subject has been free of disease and without treatment for at least 5 years
• Last chemotherapy \<4 weeks prior to visit 1
• Last anti-CD20 therapy (non-radiolabelled) \<4 weeks prior to visit 1
• Last corticosteroid \<2 weeks prior to visit 1 unless the dose is less or equal of 10 mg/day prednisolone or equivalent
• High-dose therapy with stem cell support \<6 months prior to visit 1
• Radio-immunotherapy \<3 months prior to visit 1

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (12)

INS Paoli-Calmettes

Marseille, 13273, France

Location

HOP Lyon Sud

Pierre-Bénite, 69495, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 12200, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitätsmedizin Göttingen, Georg-August-Universität

Göttingen, 37075, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Jena

Jena, 07740, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• Kroschinsky F, Middeke JM, Janz M, Lenz G, Witzens-Harig M, Bouabdallah R, La Rosee P, Viardot A, Salles G, Kim SJ, Kim TM, Ottmann O, Chromik J, Quinson AM, von Wangenheim U, Burkard U, Berk A, Schmitz N. Phase I dose escalation study of BI 836826 (CD37 antibody) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Invest New Drugs. 2020 Oct;38(5):1472-1482. doi: 10.1007/s10637-020-00916-3. Epub 2020 Mar 14.

  PMID: 32172489 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

BI 836826

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• 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
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 27, 2011
• Study Start: August 1, 2011
• Primary Completion: November 14, 2017
• Study Completion: February 28, 2018
• Last Updated: August 11, 2020
• Results First Posted: August 11, 2020

Record last verified: 2020-08

Locations

FR (2); KR (2); DE (8)