Trial · NCT01403948
BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
NCT01403948, Phase 1, Completed, Boehringer Ingelheim; results first posted 2020-08-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL). Trials, record NCT01403948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01403948
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
- NCT number
- NCT01403948
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 48 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- BI 836826
- First posted
- 2011-07-27
- Last updated
- 2020-08-11
- Other registries' IDs
- eudract:2010-024456-29
- Results first posted
- 2020-08-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients | 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. |
| Primary | Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients | 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). |
| Secondary | Tumour Size Reduction | Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25. | 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. |
| Secondary | Best Overall Response Based on All Assessment | 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 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) |
| Secondary | Best Overall Response Based on Imaging Data | Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25. | 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 |
| Secondary | Progression Free Survival (PFS) | from first treatment until disease progression or death from any cause, up to 12 months. | 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. |
| Secondary | Failure Free Survival (FFS) | from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months. | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients | From the first administration of trial medication to 7 days after the second administration, upto 36 days | Treated Set | Milligram (mg) | NUMBER |
| PRIMARY | Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients | From the first administration of trial medication to 7 days after the second administration, up to 36 days | Treated Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Tumour Size Reduction | Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25. | Treated set | Percentage | MEAN |
| SECONDARY | Best Overall Response Based on All Assessment | Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT) | Treated set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Overall Response Based on Imaging Data | Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25. | Treated set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | from first treatment until disease progression or death from any cause, up to 12 months. | Treated set | days | MEDIAN |
| SECONDARY | Failure Free Survival (FFS) | from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months. | Treated set | days | MEDIAN |
Source ClinicalTrials.gov
Results by group160
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients | BI 836826 | 100 | Milligram (mg) | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients | BI 836826 1 mg iv (Caucasian Patients) | 0 | Participants | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients | BI 836826 3 mg iv (Caucasian Patients) | 0 | Participants | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients | BI 836826 9 mg iv (Caucasian Patients) | 0 | Participants | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients | BI 836826 25 mg iv (Caucasian Patients) | 0 | Participants | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients | BI 836826 50 mg iv (Caucasian Patients) | 0 | Participants | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients | BI 836826 100 mg iv (Caucasian Patients) | 0 | Participants | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients | BI 836826 150 mg iv (Caucasian Patients) | 3 | Participants | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients | BI 836826 200 mg iv (Caucasian Patients) | 1 | Participants | ||
| Tumour Size Reduction | BI 836826 1 mg iv (Caucasian Patients) | indicator lesions | -44.74 | Standard Deviation NA | Percentage |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BI 836826 1 mg iv (Caucasian Patients) | 1 | |
| Overall Study | STARTED | BI 836826 3 mg iv (Caucasian Patients) | 4 | |
| Overall Study | STARTED | BI 836826 9 mg iv (Caucasian Patients) | 3 | |
| Overall Study | STARTED | BI 836826 25 mg iv (Caucasian Patients) | 4 | |
| Overall Study | STARTED | BI 836826 50 mg iv (Caucasian Patients) | 6 | |
| Overall Study | STARTED | BI 836826 50mg iv (Korean Patients) | 7 | |
| Overall Study | STARTED | BI 836826 100 mg iv (Caucasian Patients) | 6 | |
| Overall Study | STARTED | BI 836826 100 mg iv (Korean Patients) | 4 | |
| Overall Study | STARTED | BI 836826 150 mg iv (Caucasian Patients) | 6 | |
| Overall Study | STARTED | BI 836826 200 mg iv (Caucasian Patients) | 7 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events2,550
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 1 mg iv (Caucasian Patients) | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 3 mg iv (Caucasian Patients) | 3 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 9 mg iv (Caucasian Patients) | 3 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 25 mg iv (Caucasian Patients) | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 50 mg iv (Caucasian Patients) | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 50mg iv (Korean Patients) | 2 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 100 mg iv (Caucasian Patients) | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 100 mg iv (Korean Patients) | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 150 mg iv (Caucasian Patients) | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 200 mg iv (Caucasian Patients) | 3 | 7 |
1 to 10 of 2,550Source ClinicalTrials.gov
See all 2,550 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BI 836826 1 mg iv (Caucasian Patients) | 0 | 1 |
| Total, all-cause mortality | BI 836826 3 mg iv (Caucasian Patients) | 0 | 4 |
| Total, all-cause mortality | BI 836826 9 mg iv (Caucasian Patients) | 1 | 3 |
| Total, all-cause mortality | BI 836826 25 mg iv (Caucasian Patients) | 1 | 4 |
| Total, all-cause mortality | BI 836826 50 mg iv (Caucasian Patients) | 2 | 6 |
| Total, all-cause mortality | BI 836826 50mg iv (Korean Patients) | 1 | 7 |
| Total, all-cause mortality | BI 836826 100 mg iv (Caucasian Patients) | 1 | 6 |
| Total, all-cause mortality | BI 836826 100 mg iv (Korean Patients) | 1 | 4 |
| Total, all-cause mortality | BI 836826 150 mg iv (Caucasian Patients) | 2 | 6 |
| Total, all-cause mortality | BI 836826 200 mg iv (Caucasian Patients) | 1 | 7 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32172489 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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