BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01403948
First received: July 26, 2011
Last updated: May 15, 2013
Last verified: May 2013
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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 Pharmaceuticals:
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:
- 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
- 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
- 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)
- Relapse or progression of disease with an indication for therapy as per investigator`s judgement
- Life expectancy of =3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
Exclusion criteria:
- Primary central nervous system (CNS) lymphoma or known CNS involvement
- 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
- Last chemotherapy <4 weeks prior to visit 1
- Last anti-CD20 therapy (non-radiolabelled) <4 weeks prior to visit 1
- Last corticosteroid <2 weeks prior to visit 1 unless the dose is less or equal of 10 mg/day prednisolone or equivalent
- High-dose therapy with stem cell support <6 months prior to visit 1
- 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 | Not yet recruiting |
| Marseille Cedex 09, France | |
| 1270.2.33001 Boehringer Ingelheim Investigational Site | Recruiting |
| Pierre Bénite, France | |
| Germany | |
| 1270.2.49006 Boehringer Ingelheim Investigational Site | Active, not recruiting |
| Berlin, Germany | |
| 1270.2.49005 Boehringer Ingelheim Investigational Site | Recruiting |
| Dresden, Germany | |
| 1270.2.49004 Boehringer Ingelheim Investigational Site | Active, not recruiting |
| Frankfurt am Main, Germany | |
| 1270.2.49003 Boehringer Ingelheim Investigational Site | Active, not 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 | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01403948 History of Changes |
| Other Study ID Numbers: | 1270.2, 2010-024456-29 |
| Study First Received: | July 26, 2011 |
| Last Updated: | May 15, 2013 |
| 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 May 19, 2013