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

This study is currently recruiting participants.
Verified April 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01403948
First received: July 26, 2011
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
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-Label, Dose-Escalation Trial With BI 836826 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma of B Cell Origin

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary objective is to assess the safety of the drug in humans and to determine the maximum tolerated dose (MTD) of BI 836826. If an MTD is not reached, an Optimal biological dose (OBD) may be defined [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • The safety of BI 836826 will be assessed by a descriptive analysis of incidence and intensity of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumour size reduction [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Best overall response [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Failure free survival [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: August 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with relapsed or refractory NHL
Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments
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. 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
  2. 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
  3. 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)
  4. Relapse or progression of disease with an indication for therapy as per investigator`s judgement
  5. Life expectancy of =3 months
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2

Exclusion criteria:

  1. Primary central nervous system (CNS) lymphoma or known CNS involvement
  2. 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
  3. Last chemotherapy <4 weeks prior to visit 1
  4. Last anti-CD20 therapy (non-radiolabelled) <4 weeks prior to visit 1
  5. Last corticosteroid <2 weeks prior to visit 1 unless the dose is less or equal of 10 mg/day prednisolone or equivalent
  6. High-dose therapy with stem cell support <6 months prior to visit 1
  7. Radio-immunotherapy <3 months prior to visit 1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403948

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

Locations
France
1270.2.33003 Boehringer Ingelheim Investigational Site Not yet recruiting
Lille Cedex, France
1270.2.33002 Boehringer Ingelheim Investigational Site Recruiting
Marseille Cedex 09, France
1270.2.33001 Boehringer Ingelheim Investigational Site Recruiting
Pierre Bénite, France
Germany
1270.2.49006 Boehringer Ingelheim Investigational Site Recruiting
Berlin, Germany
1270.2.49005 Boehringer Ingelheim Investigational Site Recruiting
Dresden, Germany
1270.2.49004 Boehringer Ingelheim Investigational Site Recruiting
Frankfurt am Main, Germany
1270.2.49003 Boehringer Ingelheim Investigational Site Recruiting
Göttingen, Germany
1270.2.49001 Boehringer Ingelheim Investigational Site Recruiting
Hamburg, Germany
1270.2.49002 Boehringer Ingelheim Investigational Site Recruiting
Heidelberg, Germany
1270.2.49007 Boehringer Ingelheim Investigational Site Recruiting
Jena, Germany
1270.2.49008 Boehringer Ingelheim Investigational Site Recruiting
Ulm, Germany
Korea, Republic of
1270.2.82001 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01403948     History of Changes
Other Study ID Numbers: 1270.2, 2010-024456-29
Study First Received: July 26, 2011
Last Updated: April 2, 2014
Health Authority: France: Agence Nationale sécurité médicament et des produits santé
Germany: Paul-Ehrlich-Institute
South Korea: Ministry of Food and Drug Safety (MFDS)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014