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BI 836826

Antineoplastic Agents, Immunological

Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments

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

Boehringer Ingelheim

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.

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

A Phase I, Open-Label, Dose-Escalation Trial With BI 836826 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma of B Cell Origin

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 during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL).

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.

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)

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

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.

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.

BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.

Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.

BI 836826 1 mg iv (Caucasian Patients)

BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.

Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.

BI 836826 3 mg iv (Caucasian Patients)

BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.

Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.

BI 836826 9 mg iv (Caucasian Patients)

BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.

Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.

BI 836826 25 mg iv (Caucasian Patients)

BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.

Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.

BI 836826 50 mg iv (Caucasian Patients)

BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.

Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.

BI 836826 50mg iv (Korean Patients)

BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.

Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.

BI 836826 100 mg iv (Caucasian Patients)

BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.

Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.

BI 836826 100 mg iv (Korean Patients)

BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.

Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.

BI 836826 150 mg iv (Caucasian Patients)

BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin.

Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.

BI 836826 200 mg iv (Caucasian Patients)

Total

Age, Continuous

Sex: Female, Male

Ethinicity was not captured in this trial.

Race (NIH/OMB)

Treated set (TS): Treated set (TS) consists of all patients who received at least 1 dose of BI 836826.

Boehringer Ingelheim, Call Center

Caucasian patients were treated in the dose-escalation phase with BI 836826 as an intravenous infusion until the patient met criteria for stopping study medication during the MTD evaluation period. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.

Spots Global Cancer Trial Database for BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

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