Lymphoma, Non-HodgkinPhase 1NCT01403948

BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

A Phase 1 study testing BI 836826 in people with Lymphoma, Non-Hodgkin, run by Boehringer Ingelheim at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphoma, Non-Hodgkin
What is being tested?: BI 836826
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 12 sitesin 3 countries
Study dates: 1 Aug 2011to 28 Feb 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 or 1

Who cannot join

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

Trial locations and contacts

12 sites in 3 countries.

Country

City, postcode or hospital

12 sites in 3 countries

Germany8 sites

Charité - Universitätsmedizin Berlin
Berlin, 12200
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075
Asklepios Klinik St. Georg
Hamburg, 20099
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum Jena
Jena, 07740
Universitätsklinikum Ulm
Ulm, 89081

Other trials in Germany

France2 sites

INS Paoli-Calmettes
Marseille, 13273
HOP Lyon Sud
Pierre-Bénite, 69495

Other trials in France

South Korea2 sites

Seoul National University Hospital
Seoul, 110-744
Samsung Medical Center
Seoul, 135-710

Other trials in South Korea

About this study

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

Conditions: Lymphoma, Non-Hodgkin
Being tested: BI 836826
Medical subject headings: Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 836826Drug
Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion

Study groups in NCT01403948
Study group	Role	What they receive
Patients with relapsed or refractory NHL	Experimental	Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments Receives: Drug: BI 836826

What is being measured

The primary outcome is the main question the study is designed to answer.

Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients. The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course. In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration.. A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826.
Measured: From the first administration of trial medication to 7 days after the second administration, upto 36 days
Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients
Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL).
Measured: From the first administration of trial medication to 7 days after the second administration, up to 36 days

Secondary outcomes (5)

Tumour Size Reduction
Tumour size reduction (lymph nodes, spleen, \& liver nodules) defined as best percentage change from baseline in sum of products of diameter (SPD). Negative value represents decrease in tumour size, \& positive value represents an increase in size. The tumour size of lymph nodes was to be measured as SPD of 2 perpendicular dimensions for up to 6 indicator lesions identified at baseline CT scan. Spleen \& liver were to be described if considered enlarged at baseline by physical examination or CT scan. If nodules present in spleen \&/or liver, was to be measured in 2 perpendicular dimensions. Median, 25th \& 75th percentiles are calculated from unadjusted Kaplan-Meier curve for each treatment cohort.
Measured: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
Best Overall Response Based on All Assessment
Best overall response was best response at any of CT scans and investigator assesment (incase the recent CT scan was not available). Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:
1. Complete remission (CR)
2. Complete remission unconfirmed (CRu)
3. Partial remission (PR)
4. Stable disease (SD)
5. progressive disease (PD)
Measured: Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)
Best Overall Response Based on Imaging Data
Best overall response based on imaging data. Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:
1. Complete remission
2. Complete remission unconfirmed
3. Partial remission
4. Stable disease:
5. progressive disease
Measured: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
Progression Free Survival (PFS)
PFS was defined as the time from first treatment with BI 836826 until disease progression or death from any cause. For disease progression one of the following criteria was required:
- Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort.
Measured: from first treatment until disease progression or death from any cause, up to 12 months.
Failure Free Survival (FFS)
FFS was defined as the time from first treatment with BI 836826 until objective disease progression, death, or start of next Non-Hodgkin lymphoma (NHL) therapy.For disease progression one of the following criteria was required:
- Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort.
Measured: from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201128 Feb 2018

First posted27 Jul 2011 (estimated)
Study start1 Aug 2011
Primary completion14 Nov 2017
Study completion28 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Intervention model: Sequential
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01403948
Sponsor's protocol ID: 1270.2
Other IDs: 2010-024456-29
Status last verified: Aug 2020
First submitted: 26 Jul 2011
Last updated: 11 Aug 2020
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 32172489

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01403948
Acronym / sponsor ID: 1270.2
Conditions: Lymphoma, Non-Hodgkin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Aug 2011 (actual)
Primary completion: 14 Nov 2017 (actual)
Study completion: 28 Feb 2018 (actual)
First posted: 27 Jul 2011 (estimated)
Results: Posted 11 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with relapsed or refractory NHL	Experimental	Drug: BI 836826Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 836826Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion	Drug	Patients with relapsed or refractory NHL

Primary outcome

Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
Time frame: From the first administration of trial medication to 7 days after the second administration, upto 36 days
The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients. The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course. In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration.. A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826.
Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients
Time frame: From the first administration of trial medication to 7 days after the second administration, up to 36 days
Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL).

5 secondary outcomes

Tumour Size Reduction
Time frame: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
Best Overall Response Based on All Assessment
Time frame: Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)
Best Overall Response Based on Imaging Data
Time frame: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
Progression Free Survival (PFS)
Time frame: from first treatment until disease progression or death from any cause, up to 12 months.
Failure Free Survival (FFS)
Time frame: from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.

Results and safety

Results posted to the registry on 11 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 836826 1 mg iv (Caucasian Patients)	1	0
BI 836826 3 mg iv (Caucasian Patients)	4	0
BI 836826 9 mg iv (Caucasian Patients)	3	0
BI 836826 25 mg iv (Caucasian Patients)	4	0
BI 836826 50 mg iv (Caucasian Patients)	6	0
BI 836826 50mg iv (Korean Patients)	7	0
BI 836826 100 mg iv (Caucasian Patients)	6	0
BI 836826 100 mg iv (Korean Patients)	4	0
BI 836826 150 mg iv (Caucasian Patients)	6	0
BI 836826 200 mg iv (Caucasian Patients)	7	0

Primary outcome: Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients

Time frame: From the first administration of trial medication to 7 days after the second administration, upto 36 days. Number. Unit: Milligram (mg)

Measure	BI 836826 n = 37
Value	100

Population analysed: Treated Set

Primary outcome: Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients

Time frame: From the first administration of trial medication to 7 days after the second administration, up to 36 days. Count of participants. Unit: Participants

Measure	BI 836826 1 mg iv (Caucasian Patients) n = 1	BI 836826 3 mg iv (Caucasian Patients) n = 4	BI 836826 9 mg iv (Caucasian Patients) n = 3	BI 836826 25 mg iv (Caucasian Patients) n = 4	BI 836826 50 mg iv (Caucasian Patients) n = 6	BI 836826 100 mg iv (Caucasian Patients) n = 6	BI 836826 150 mg iv (Caucasian Patients) n = 6	BI 836826 200 mg iv (Caucasian Patients) n = 7
Value	0	0	0	0	0	0	3	1

Population analysed: Treated Set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 836826 1 mg iv (Caucasian Patients)	0 of 1 (0%)	1 of 1 (100%)	0 of 1
BI 836826 3 mg iv (Caucasian Patients)	3 of 4 (75%)	4 of 4 (100%)	0 of 4
BI 836826 9 mg iv (Caucasian Patients)	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
BI 836826 25 mg iv (Caucasian Patients)	1 of 4 (25%)	4 of 4 (100%)	1 of 4
BI 836826 50 mg iv (Caucasian Patients)	5 of 6 (83.3%)	6 of 6 (100%)	2 of 6
BI 836826 50mg iv (Korean Patients)	4 of 7 (57.1%)	7 of 7 (100%)	1 of 7
BI 836826 100 mg iv (Caucasian Patients)	5 of 6 (83.3%)	6 of 6 (100%)	1 of 6
BI 836826 100 mg iv (Korean Patients)	3 of 4 (75%)	4 of 4 (100%)	1 of 4
BI 836826 150 mg iv (Caucasian Patients)	3 of 6 (50%)	6 of 6 (100%)	2 of 6
BI 836826 200 mg iv (Caucasian Patients)	5 of 7 (71.4%)	7 of 7 (100%)	1 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32172489Kroschinsky 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

12 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 836826 in people with Lymphoma, Non-Hodgkin, run by Boehringer Ingelheim at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany, France, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients (time frame: From the first administration of trial medication to 7 days after the second administration, upto 36 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01403948, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.