BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
Conditions
Lymphoma, Non-Hodgkin
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: BI 836826
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
1270.2.33002 Boehringer Ingelheim Investigational Site
Marseille Cedex 09, France
Status: Suspended
1270.2.33004 Boehringer Ingelheim Investigational Site
Pessac cedex, France
Status: Suspended
1270.2.33001 Boehringer Ingelheim Investigational Site
Pierre Bénite, France
Status: Suspended
1270.2.49006 Boehringer Ingelheim Investigational Site
Berlin, Germany
Status: Active, not recruiting
1270.2.49005 Boehringer Ingelheim Investigational Site
Dresden, Germany
Status: Active, not recruiting
1270.2.49004 Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
Status: Active, not recruiting
1270.2.49003 Boehringer Ingelheim Investigational Site
Göttingen, Germany
Status: Recruiting
1270.2.49001 Boehringer Ingelheim Investigational Site
Hamburg, Germany
Status: Completed
1270.2.49002 Boehringer Ingelheim Investigational Site
Heidelberg, Germany
Status: Recruiting
1270.2.49007 Boehringer Ingelheim Investigational Site
Jena, Germany
Status: Recruiting
1270.2.49008 Boehringer Ingelheim Investigational Site
Ulm, Germany
Status: Recruiting
1270.2.82001 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Status: Recruiting
1270.2.82002 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Status: Recruiting
Start Date
August 2011
Completion Date
June 2016
Sponsors
Boehringer Ingelheim
Source
Boehringer Ingelheim
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page