BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
NCT ID: NCT01403948
Last Updated: 2020-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2011-08-01
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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SEQUENTIAL
TREATMENT
NONE
Study Groups
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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
BI 836826
Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion
Interventions
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BI 836826
Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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INS Paoli-Calmettes
Marseille, , France
HOP Lyon Sud
Pierre-Bénite, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Jena
Jena, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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References
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Kroschinsky F, Middeke JM, Janz M, Lenz G, Witzens-Harig M, Bouabdallah R, La Rosee P, Viardot A, Salles G, Kim SJ, Kim TM, Ottmann O, Chromik J, Quinson AM, von Wangenheim U, Burkard U, Berk A, Schmitz N. Phase I dose escalation study of BI 836826 (CD37 antibody) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Invest New Drugs. 2020 Oct;38(5):1472-1482. doi: 10.1007/s10637-020-00916-3. Epub 2020 Mar 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2010-024456-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1270.2
Identifier Type: -
Identifier Source: org_study_id
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