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

Phase 1
18 Years
Open (Enrolling)
Lymphoma, Non-Hodgkin

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Trial Information

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

Inclusion 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

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

12 month

Safety Issue:


Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals


France: Agence Nationale sécurité médicament et des produits santé

Study ID:




Start Date:

August 2011

Completion Date:

November 2014

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Lymphoma
  • Lymphoma, Non-Hodgkin