Clinical trial NCT01403948: BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma, Non-Hodgkin
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-07-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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 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

Primary outcomes:
measure: Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
timeFrame: From the first administration of trial medication to 7 days after the second administration, upto 36 days
measure: Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients
timeFrame: From the first administration of trial medication to 7 days after the second administration, up to 36 days
Secondary outcomes:
measure: Tumour Size Reduction
timeFrame: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
measure: Best Overall Response Based on All Assessment
timeFrame: Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)
measure: Best Overall Response Based on Imaging Data
timeFrame: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
measure: Progression Free Survival (PFS)
timeFrame: from first treatment until disease progression or death from any cause, up to 12 months.
measure: Failure Free Survival (FFS)
timeFrame: from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.
Other outcomes:
Locations:
city: Marseille Cedex 09
country: France
facility: INS Paoli-Calmettes
city: Pierre Bénite
country: France
facility: HOP Lyon Sud
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen, Georg-August-Universität
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.