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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01403948
Recruitment Status : Active, not recruiting
First Posted : July 27, 2011
Last Update Posted : December 27, 2017
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: BI 836826 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : August 1, 2011
Primary Completion Date : November 14, 2017
Estimated Study Completion Date : January 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Incidence and intensity of adverse events graded according to CTCAE (version 4.0) [ Time Frame: 12 month ]
  2. Maximun tolerated dose (MTD) as defined by Dose limiting toxicity (DLT) [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. Tumour size reduction [ Time Frame: 12 month ]
  2. Best overall response [ Time Frame: 12 month ]
  3. Progression free survival [ Time Frame: 12 month ]
  4. Failure free survival [ Time Frame: 12 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 or 1

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403948

INS Paoli-Calmettes
Marseille Cedex 09, France, 13273
HOP Lyon Sud
Pierre Bénite, France, 69495
Charité - Universitätsmedizin Berlin
Berlin, Germany, 12200
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany, 60590
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, Germany, 37075
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitätsklinikum Jena
Jena, Germany, 07740
Universitätsklinikum Ulm
Ulm, Germany, 89081
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01403948     History of Changes
Other Study ID Numbers: 1270.2
2010-024456-29 ( EudraCT Number )
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

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