Trial · NCT01296932
BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)
NCT01296932, Phase 1, Completed, Boehringer Ingelheim; results first posted 2020-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL). Trials, record NCT01296932. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01296932
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)
- NCT number
- NCT01296932
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 37 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Interventions
- BI 836826
- First posted
- 2011-02-16
- Last updated
- 2020-08-20
- Other registries' IDs
- eudract:2010-021488-34
- Results first posted
- 2020-08-20
- Limitations and caveats
The trial was discontinued due to lack of recruitment before a formal maximum tolerated dose (MTD) was established based on the number of patients with Dose Limiting Toxicities (DLTs) in the first treatment cycle.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Dose-Limiting Toxicities Adverse Events (DLTs) | 14 days after first administration of BI836826 (MTD evaluation period) | Dose-Limiting Toxicities (DLTs) were defined as any drug-related non-haematologic adverse event of Common Terminology Criteria for AE (CTCAE) Grade 3 or higher, except infusion related reactions associated with the administration of BI 836826. In addition complications due to haematologic AEs were considered as DLTs and were added in more detail in an amendment later on. |
| Primary | Maximum Tolerated Dose (MTD) | 14 days after first administration of BI836826 (MTD evaluation period) | The maximum tolerated dose (MTD) was defined as the highest dose of BI 836826 studied for which the incidence of DLT was no more than 17% (i.e. 1 out of 6 patients) during the first treatment cycle. For those patients who received more than 1 cycle of BI 836826, all AEs corresponding to the DLT were considered for the purpose of confirming the MTD and for the selection of the recommended dose for treatment of the expansion cohort and for further development. All DLTs, occurring during the first or repeated treatment cycle were reported as significant AEs. As it was not possible to recruit a sufficient number of patients whilst the first part of the trial was still in progress, the recruitment was ended by the sponsor before the MTD or optimal biological dose (OBD) was reached. |
| Secondary | Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood | baseline and ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days | In most patients with relapsed or refractory chronic lymphocytic leukaemia (CLL), malignant B-cells represent the majority of lymphocytes in the peripheral blood. Reduction of CLL-cells was assessed in the peripheral blood by absolute lymphocyte count, and flow cytometry. The number of lymphocytes in the peripheral blood was analysed in terms of the best percentage change from baseline until start of subsequent CLL therapy or progressive disease (PD). |
| Secondary | Number of Patients With Improved Haemoglobin Count for at Least Two Subsequent Response Assessments | ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days | In patients with haemoglobin counts below the limits of normal at baseline, improvement in this count during therapy potentially indicated a benefit for the patient. Number of patients with improved haemoglobin count for at least two subsequent response assessments which fulfil International Workshop on Chronic Lymphocytic Leukemia (IWCLL) response criteria for Complete Remission (CR) or Partial Remission (PR). The response was assessed before Progressive Disease (PD) or start of new Chronic Lymphocytic Leukaemia (CLL) therapy. |
| Secondary | Number of Patients With Improved Platelet Count for at Least Two Subsequent Response Assessments | ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days | In patients with platelet counts below the limits of normal at baseline, improvement in this count during therapy potentially indicated a benefit for the patient. Number of patients with improved platelet count for at least two subsequent response assessments which fulfil International Workshop on Chronic Lymphocytic Leukemia (IWCLL) response criteria for Complete Remission (CR) or Partial Remission (PR). The response was assessed before Progressive Disease (PD) or start of new Chronic Lymphocytic Leukaemia (CLL) therapy. |
| Secondary | Number of Patients With Improved Neutrophil Count for at Least Two Subsequent Response Assessments | ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days | In patients with neutrophil count below the limits of normal at baseline, improvement in this count during therapy potentially indicated a benefit for the patient. Number of patients with improved neutrophil count for at least two subsequent response assessments which fulfil International Workshop on Chronic Lymphocytic Leukemia (IWCLL) response criteria for Complete Remission (CR) or Partial Remission (PR). The response was assessed before Progressive Disease (PD) or start of new Chronic Lymphocytic Leukaemia (CLL) therapy. |
| Secondary | Best Overall Response According to 'International Workshop on Chronic Lymphocytic Leukemia' (IWCLL) Criteria | Data collected up to cut-off date 26Oct2016 until Progressive disease (PD) to start of next Chronic Lymphocytic Leukaemia (CLL) therapy, Up to 1809 days. | Response was assessed according to the IWCLL (International Workshop on Chronic Lymphocytic Leukemia) guidelines based on laboratory data from the peripheral blood and clinical examination by the investigator after each cycle prior to administration of the next dose of BI 836826, at the end of the treatment (EOT) visit, and at all Follow-up Visits. Best overall response will be analysed descriptively. Frequency distributions will be used to examine this endpoint. |
| Secondary | Progression-free Survival | Data collected up to cut-off date 26Oct2016, Up to 1809 days. | Progression-free survival (PFS) was defined as the time from the first administration of BI 836826 until disease progression or death, whichever occurred first. Disease progression= At least one of the following: * 50+% increase in blood lymphocytes over baseline with an absolute number of B-lymphocytes of at least 5x109/L * Progression of lymphadenopathy * 50+% increase in the previously noted enlargement of the liver or new appearance of hepatomegaly * 50+% increase in the previously noted enlargement of the spleen or new appearance of splenomegaly * 50+% Decrease of platelet counts or to less than 100x109/L secondary to CLL and unrelated to autoimmune cytopenia * Decrease of haemoglobin levels by more than 20 g/L, or to less than 100 g/L secondary to CLL and unrelated to autoimmune cytopenia T Transformation to a more aggressive histology, e.g. Richter syndrome. |
| Secondary | Failure-free Survival | Data collected up to cut-off date 26Oct2016, Up to 1809 days. | Failure-free survival (FFS) was defined as the time from the first administration of BI 836826 until disease progression or death, or start of next Chronic Lymphocytic Leukemia (CLL) therapy, whichever occurred first. Disease progression= At least one of the following: * 50+% increase in blood lymphocytes over baseline with an absolute number of B-lymphocytes of at least 5x109/L * Progression of lymphadenopathy * 50+% increase in the previously noted enlargement of the liver or new appearance of hepatomegaly * 50+% increase in the previously noted enlargement of the spleen or new appearance of splenomegaly * 50+% Decrease of platelet counts or to less than 100x109/L secondary to CLL and unrelated to autoimmune cytopenia * Decrease of haemoglobin levels by more than 20 g/L, or to less than 100 g/L secondary to CLL and unrelated to autoimmune cytopenia T Transformation to a more aggressive histology, e.g. Richter syndrome. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood | baseline and ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days | All patients who received at least one application of the drug BI 836826, had a baseline and at least one post-baseline assessment of the number of lymphocytes in the peripheral blood. | Percentage of change (%) | MEAN |
| SECONDARY | Number of Patients With Improved Haemoglobin Count for at Least Two Subsequent Response Assessments | ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days | Treated Set (TS): All patients who received at least one application of the drug BI 836826. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Improved Platelet Count for at Least Two Subsequent Response Assessments | ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days | TS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Improved Neutrophil Count for at Least Two Subsequent Response Assessments | ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days | TS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Overall Response According to 'International Workshop on Chronic Lymphocytic Leukemia' (IWCLL) Criteria | Data collected up to cut-off date 26Oct2016 until Progressive disease (PD) to start of next Chronic Lymphocytic Leukaemia (CLL) therapy, Up to 1809 days. | TS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival | Data collected up to cut-off date 26Oct2016, Up to 1809 days. | TS | Days | MEDIAN |
| SECONDARY | Failure-free Survival | Data collected up to cut-off date 26Oct2016, Up to 1809 days. | TS | Days | MEDIAN |
| PRIMARY | Number of Patients With Dose-Limiting Toxicities Adverse Events (DLTs) | 14 days after first administration of BI836826 (MTD evaluation period) | The maximum tolerated dose (MTD) evaluation set: This includes all patients who were documented to have received at least one dose of trial medication and were not replaced for the MTD evaluation. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Maximum Tolerated Dose (MTD) | 14 days after first administration of BI836826 (MTD evaluation period) | The trial was discontinued prematurely due to lack of recruitment before the MTD based on the frequency of patients with DLTs in the first treatment cycle was reached. |
Source ClinicalTrials.gov
Results by group144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood | BI 836826 1 Milligram | -11.39 | Standard Deviation 31.39 | Percentage of change (%) | |
| Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood | BI 836826 3 Milligram | -21.20 | Standard Deviation 10.08 | Percentage of change (%) | |
| Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood | BI 836826 9 Milligram | -48.21 | Standard Deviation 57.39 | Percentage of change (%) | |
| Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood | BI 836826 25 Milligram | -48.15 | Standard Deviation 34.01 | Percentage of change (%) | |
| Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood | BI 836826 50 Milligram | -49.35 | Standard Deviation 31.44 | Percentage of change (%) | |
| Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood | BI 836826 100 Milligram | -81.81 | Standard Deviation 11.03 | Percentage of change (%) | |
| Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood | BI 836826 200 Milligram | -79.22 | Standard Deviation 39.94 | Percentage of change (%) | |
| Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood | BI 836826 400 Milligram | -93.40 | Standard Deviation 9.76 | Percentage of change (%) | |
| Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood | BI 836826 800 Milligram | -47.14 | Standard Deviation 103.29 | Percentage of change (%) | |
| Number of Patients With Improved Haemoglobin Count for at Least Two Subsequent Response Assessments | BI 836826 1 Milligram | NO | 3 | Participants |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BI 836826 1 Milligram | 3 | |
| Overall Study | STARTED | BI 836826 3 Milligram | 3 | |
| Overall Study | STARTED | BI 836826 9 Milligram | 6 | |
| Overall Study | STARTED | BI 836826 25 Milligram | 6 | |
| Overall Study | STARTED | BI 836826 50 Milligram | 3 | |
| Overall Study | STARTED | BI 836826 100 Milligram | 3 | |
| Overall Study | STARTED | BI 836826 200 Milligram | 6 | |
| Overall Study | STARTED | BI 836826 400 Milligram | 3 | |
| Overall Study | STARTED | BI 836826 800 Milligram | 4 | |
| Overall Study | COMPLETED | BI 836826 1 Milligram | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events2,376
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 Milligram | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 3 Milligram | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 9 Milligram | 4 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 25 Milligram | 3 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 50 Milligram | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 100 Milligram | 3 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 200 Milligram | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 400 Milligram | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | BI 836826 800 Milligram | 2 | 4 | |
| other | Eosinophilia | Blood and lymphatic system disorders | BI 836826 1 Milligram | 0 | 3 |
1 to 10 of 2,376Source ClinicalTrials.gov
See all 2,376 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BI 836826 1 Milligram | 0 | 3 |
| Total, all-cause mortality | BI 836826 3 Milligram | 0 | 3 |
| Total, all-cause mortality | BI 836826 9 Milligram | 0 | 6 |
| Total, all-cause mortality | BI 836826 25 Milligram | 0 | 6 |
| Total, all-cause mortality | BI 836826 50 Milligram | 0 | 3 |
| Total, all-cause mortality | BI 836826 100 Milligram | 0 | 3 |
| Total, all-cause mortality | BI 836826 200 Milligram | 0 | 6 |
| Total, all-cause mortality | BI 836826 400 Milligram | 0 | 3 |
| Total, all-cause mortality | BI 836826 800 Milligram | 0 | 4 |
| Total, other adverse events | BI 836826 1 Milligram | 3 | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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