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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004999-29 | EudraCT Number |
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| Name | Class |
|---|---|
| BioInvent International AB | INDUSTRY |
| Bloodwise | OTHER |
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The purpose of this trial is to identify the tolerable dose of BI-1206 (both alone and in combination) for patients with B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an anti-CD20 antibody.
The molecule CD32b is thought to be present on many B-cells including the malignant B-cells in some types of lymphoma and leukaemia. The study drug, BI-1206, is an anti-CD32b monoclonal antibody which attaches to CD32b on the surface of B-cells and is thought to act by recruiting host immune cells toward the tumour leading to cancer cell death as well as enhancing the anti-cancer effect of other anti-CD20 antibodies such as rituximab by stopping them being absorbed by cells.
The study is a first in man clinical trial of the drug called BI-1206 on its own and then also in combination with an anti-CD20 antibody (such as rituximab) which is commonly used to treat lymphoma and some types of leukaemia.
The four main aims of this trial are to find out:
Approximately 81 patients with relapsed or refractory CD32b positive B-cell lymphoma or leukaemia were planned for the trial. Approximately 34 patients to establish the maximum tolerated doses (MTDs) in Part A and a further 40 to 50 patients recruited to two expansion cohorts; one of BI-1206 alone and one of BI-1206 plus rituximab (Part B). The final number depending on the number of dose escalations required to reach the MTD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Arm 1: BI-1206 single agent dose escalation phase | Experimental | BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy). |
|
| Part A: Arm 2: Combination of BI-1206 with rituximab escalation phase | Experimental | Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts). |
|
| Part B: Arm1: BI-1206 single agent expansion phase | Experimental | Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 chronic lymphocytic leukaemia (CLL) patients and six mantle cell lymphoma (MCL) patients. |
|
| Part B: Arm 2: Combination of BI-1206 with rituximab expansion phase | Experimental | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI-1206 single agent dose escalation phase | Biological | BI-1206 single agent dose escalation phase to determine the MTD or maximum administered dose (MAD) and recommended Phase II dose (RP2D) for evaluation of BI-1206. |
| Measure | Description | Time Frame |
|---|---|---|
| Documenting Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs) (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206. | To recommend a dose for future trials with BI-1206 by finding the highest safe dose which can be given to patients. | Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab. |
| Documenting AEs, SAEs (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206 and, Where Appropriate, Anti-CD20 Antibody. | Establishing the MTD or maximum administered dose MAD of BI-1206 and an anti-CD20 antibody given once weekly for four weeks, via intravenous infusion in patients with relapsed or refractory B-cell malignancies. | Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) for BI-1206 | Maximum observed serum concentration after intravenous BI-1206 administration | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) |
| Measurement of PK Parameter Area Under the Serum Concentration-time Curve From Time 0 to the Last Time Point (AUClast) for BI-1206 |
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Inclusion Criteria:
Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
B-cell lymphoma or CLL proven by histology or flow cytometry, relapsed or refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient. Patients should have received at least one line of conventional previous therapy which must have included a rituximab based regimen.
CD32b positive malignancy as demonstrated centrally by immunohistochemistry or flow cytometry prior to study entry. Available tissue or blood must have been taken within six months of study entry.
Life expectancy of at least 12 weeks.
World Health Organisation (WHO) performance status of 0-2 (Appendix 1).
Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week before their first dose of mAb (BI-1206 and/or rituximab) as part of this study.
Laboratory Test Value required
Haemoglobin (Hb) ≥9.0 g/dL (red cell support is permissible)
Absolute neutrophil count (ANC) ≥1.0 x 10^9/L (or >0.5 x 10^9/L if due to lymphoma), granulocyte - colony stimulating factor (G-CSF) support is not permissible at screening
Platelet count ≥50 x 10^9/L (or ≥30 x 10^9/L if due to malignant involvement of bone marrow)
Either:
Serum bilirubin ≤1.5 x upper limit of normal (ULN) unless raised due to Gilbert's syndrome in which case up to 3 x ULN is permissible.
Or:
Alanine amino-transferase (ALT) and /or aspartate amino-transferase (AST) ≤ 2.5 x ULN unless raised due to malignant hepatic involvement in which case up to 5 x ULN is permissible
Either:
Calculated creatinine clearance (Cockcroft Gault) ≥30 mL/min (uncorrected value)
Or:
Isotope clearance measurement ≥30 mL/min (corrected)
18 years or over.
B-cell lymphoma patients only: patients has at least one measurable lesion by CT scan (defined as greater than 1.5 cm in one axis) or in the case of Waldenström's macroglobulinemia, disease must be assessable by the criteria stated in Appendix 6 of the protocol.
Patients recruited to Arm 2 in Parts A and B (combination arms) only: CD20 positive malignancy as demonstrated by immunohistochemistry or flow cytometry prior to trial entry.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Davies, Prof | University of Southampton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leicester Royal Infirmary | Leicester | England | LE1 5WW | United Kingdom | ||
| Christie Hospital |
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Trial participants were enrolled at four trial sites between 27 October 2016 and 09 December 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2019 |
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| Combination of BI-1206 with rituximab escalation phase | Biological | An investigation of combination treatment of BI-1206 with rituximab. |
|
| BI-1206 single agent expansion phase | Biological | BI-1206 single agent expansion phase at the RP2D. |
|
| Combination of BI-1206 with rituximab expansion phase | Biological | BI-1206 in combination with rituximab at the RP2D. |
|
Area under the serum concentration-time curve from time 0 to the last time point after intravenous BI-1206 administration. |
| Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) |
| Measurement of PK Parameter Half-life (T1/2) for BI-1206 | BI-1206 half-life after intravenous administration | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) |
| Measurement of PK Parameter Total Body Clearance (CL) for BI-1206 | Total body clearance after intravenous BI-1206 administration | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) |
| Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206 | Volume of distribution after administration of BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) |
| Measurement of Anti-drug Antibody (ADA) Response to BI-1206 During the BI-1206 Treatment Period Using ELISA | Patients with true ADA response | Pre dose at weeks 1, 5 and 8, maintenance phase and off-study visit. |
| Measurement of Peripheral Blood B-lymphocyte Depletion During the BI-1206 Treatment Period Using Flow Cytometry. | Number of patients with B-lymphocyte depletion during BI-1206 treatment period. | During induction phase (up to 8 weeks). |
| Assessment of Best Disease Response According to Criteria for Malignant Lymphoma (Cheson, 2014) Waldenström Macroglobulinaemia Assessment Criteria (Owen 2013, Kimby 2006) or NCI Chronic Lymphocytic Leukaemia (CLL) Criteria (Hallek, 2008). | To look for signs of anti-tumour activity of BI-1206 alone and in combination in patients with relapsed or refractory B-cell malignancies | Response evaluated 4 weeks after last dose in induction phase, every 16 weeks during maintenance phase and at off-study. |
| Measure Progression Free Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients | To measure the time to disease progression and twelve month survival | From first BI-1206 administration up to 12 months |
| Measure Overall Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients | To measure the time to disease progression and twelve month survival | From first BI-1206 administration up to 12 months. Participants whose last reported status was not death were censored. |
| Manchester |
| England |
| M20 4BX |
| United Kingdom |
| Oxford Cancer and Haematology Centre, Churchill Hospital | Oxford | England | OX3 7LE | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | S016 6YD | United Kingdom |
| FG001 | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab. |
| FG002 | Part B: Arm1: BI-1206 Single Agent Expansion Phase | Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D. |
| FG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
| COMPLETED |
|
| NOT COMPLETED |
|
Trial terminated before opening Part B.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206. |
| BG001 | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab. |
| BG002 | Part B: Arm1: BI-1206 Single Agent Expansion Phase | Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D. |
| BG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Documenting Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs) (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206. | To recommend a dose for future trials with BI-1206 by finding the highest safe dose which can be given to patients. | Safety population | Posted | Number | Number of events | Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab. |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Documenting AEs, SAEs (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206 and, Where Appropriate, Anti-CD20 Antibody. | Establishing the MTD or maximum administered dose MAD of BI-1206 and an anti-CD20 antibody given once weekly for four weeks, via intravenous infusion in patients with relapsed or refractory B-cell malignancies. | Safety population | Posted | Number | BI-1206 MAD (mg) | Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab. |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) for BI-1206 | Maximum observed serum concentration after intravenous BI-1206 administration | Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort. | Posted | Median | Full Range | ng/mL | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measurement of PK Parameter Area Under the Serum Concentration-time Curve From Time 0 to the Last Time Point (AUClast) for BI-1206 | Area under the serum concentration-time curve from time 0 to the last time point after intravenous BI-1206 administration. | Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort. | Posted | Median | Full Range | h*ng/mL | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measurement of PK Parameter Half-life (T1/2) for BI-1206 | BI-1206 half-life after intravenous administration | Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort. | Posted | Median | Full Range | h | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measurement of PK Parameter Total Body Clearance (CL) for BI-1206 | Total body clearance after intravenous BI-1206 administration | Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort. | Posted | Median | Full Range | mL/h/kg | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206 | Volume of distribution after administration of BI-1206 | Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort. | Posted | Median | Full Range | mL/kg | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measurement of Anti-drug Antibody (ADA) Response to BI-1206 During the BI-1206 Treatment Period Using ELISA | Patients with true ADA response | Anti-drug antibody response population | Posted | Count of Participants | Participants | Pre dose at weeks 1, 5 and 8, maintenance phase and off-study visit. |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measurement of Peripheral Blood B-lymphocyte Depletion During the BI-1206 Treatment Period Using Flow Cytometry. | Number of patients with B-lymphocyte depletion during BI-1206 treatment period. | B-lymphocyte depletion population | Posted | Count of Participants | Participants | During induction phase (up to 8 weeks). |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of Best Disease Response According to Criteria for Malignant Lymphoma (Cheson, 2014) Waldenström Macroglobulinaemia Assessment Criteria (Owen 2013, Kimby 2006) or NCI Chronic Lymphocytic Leukaemia (CLL) Criteria (Hallek, 2008). | To look for signs of anti-tumour activity of BI-1206 alone and in combination in patients with relapsed or refractory B-cell malignancies | Response population | Posted | Count of Participants | Participants | Response evaluated 4 weeks after last dose in induction phase, every 16 weeks during maintenance phase and at off-study. |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measure Progression Free Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients | To measure the time to disease progression and twelve month survival | Progression free survival population | Posted | Count of Participants | Participants | From first BI-1206 administration up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measure Overall Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients | To measure the time to disease progression and twelve month survival | Overall survival population | Posted | Mean | Full Range | Days | From first BI-1206 administration up to 12 months. Participants whose last reported status was not death were censored. |
|
Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI 1206 or rituximab
Trial terminated before part B opened. No patients in arm B.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206. | 1 | 13 | 10 | 13 | 13 | 13 |
| EG001 | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab. | 0 | 1 | 1 | 1 | 1 | 1 |
| EG002 | Part B: Arm1: BI-1206 Single Agent Expansion Phase | Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Normal tension glaucoma | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood immunoglobulin G decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Serum ferritin increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hair texture abnormal | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
The trial was terminated early by the Sponsor based on a strategic decision and not a safety related decision. At the time of trial termination, 14 patients had received BI-1206. No patients received rituximab. As a result of the early termination Part B of the trial did not open.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Affairs Manager | Cancer Research UK Centre for Drug Development | +44 203 4696878 | regulatory@cancer.org.uk |
| Mar 21, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
|
|
|
|
| DLT - ALT |
|
| DLT - AST |
|
| DLT - infusion related reaction |
|
| OG002 | Part B: Arm1: BI-1206 Single Agent Expansion Phase | Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D. |
| OG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
|
|
| OG002 | Part B: Arm1: BI-1206 Single Agent Expansion Phase | Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D. |
| OG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
|
|
| OG002 | Part B: Arm1: BI-1206 Single Agent Expansion Phase | Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D. |
| OG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
|
|
| OG002 |
| Part B: Arm1: BI-1206 Single Agent Expansion Phase |
Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D. |
| OG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
|
|
| OG002 |
| Part B: Arm1: BI-1206 Single Agent Expansion Phase |
Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D. |
| OG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
|
|
| OG002 |
| Part B: Arm1: BI-1206 Single Agent Expansion Phase |
Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D. |
| OG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
|
|
Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients.
BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.
| OG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
|
|
Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients.
BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.
| OG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
|
|
| OG002 | Part B: Arm1: BI-1206 Single Agent Expansion Phase | Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D. |
| OG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
|
|
Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients.
BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.
| OG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
|
|
Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D. |
| OG003 | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D. |
|
|