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

This study is currently recruiting participants.
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Verified August 2017 by Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: July 26, 2011
Last updated: August 9, 2017
Last verified: August 2017
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: Intervention Model: Single Group Assignment
Masking: No masking
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:
  • Incidence and intensity of adverse events graded according to CTCAE (version 4.0) [ Time Frame: 12 month ]
  • Maximun tolerated dose (MTD) as defined by Dose limiting toxicity (DLT) [ Time Frame: 12 month ]

Secondary Outcome Measures:
  • Tumour size reduction [ Time Frame: 12 month ]
  • Best overall response [ Time Frame: 12 month ]
  • Progression free survival [ Time Frame: 12 month ]
  • Failure free survival [ Time Frame: 12 month ]

Estimated Enrollment: 53
Actual Study Start Date: August 1, 2011
Estimated Study Completion Date: January 22, 2018
Estimated Primary Completion Date: December 4, 2017 (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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01403948

Contact: Boehringer Ingelheim Call Center 1-800-243-0127

Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT01403948     History of Changes
Other Study ID Numbers: 1270.2
2010-024456-29 ( EudraCT Number )
Study First Received: July 26, 2011
Last Updated: August 9, 2017

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on August 16, 2017