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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000439-14 | EudraCT Number |
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Novartis made a decision to early terminate the sabatolimab clinical development program, including the CMBG453C12201 trial, following the negative results from other 2 trials.
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This trial seeked to extend the preliminary findings of efficacy by evaluating MBG453 in combination with hypomethylating agents (HMA) and also Bcl-2 inhibitor venetoclax.
The primary purpose of Part 1 (Safety Run-in) was to rule out excessive toxicity of MBG453, when administered in combination with azacitidine and venetoclax.
The primary purpose of the combined Part 1 and Part 2 (Safety run-in and Expansion Part) was to evaluate efficacy of MBG453, when administered in combination with azacitidine and venetoclax in adult patients with newly diagnosed AML, who were not suitable for treatment with intensive chemotherapy.
Originally, there was an analysis planned of the complete response (CR) rate, after all subjects had completed at least 12 cycles of treatment (each cycle = 28 Days) or discontinued earlier. As Novartis decided to end the development of this compound, this primary analysis was skipped and only the final study analysis presented here. At the final analysis timepoint, there was only 1 patient who didn't completed the 12 cycles of treatment or discontinued earlier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBG453+Venetoclax +Azacitidine | Experimental | Participants received MBG453 in combination with Venetoclax and Azacitidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBG453 | Drug | Solution for intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLT)(Safety run-in Patients Only) | A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value considered by the Investigator to be at least possibily related to MBG453 as a single contributor or in combination with other component(s) of study treatment that occurs during the DLT observation period and meets any of the criteria as per protolcol. | From Cycle 1 Day 8 to end of Cycle 2; Cycle =28 Days |
| Percentage of Participants Achieving Complete Remission (CR) (CR Rate) | CR rate is defined as the percentage of participants achieving a complete remission (CR) as per investigator assessment (based on IWG Cheson et al 2003, ELN 2017 Dohner et al 2017). | approx. 31 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurable Residual Disease (MRD) - Negativity Rate: Full Study Population | MRD negativity rate was defined as the percentage of participants with MRD negativity, which was defined as an MRD negative sample (frequency of LAIP below 0.1%, as determined by Multi-parameter Flow Cytometry-Measurable residual disease (MFC-MRD) at Central Lab) in participant with remission (i.e., CR or CRi) as per investigator assessment (based on IWG Cheson et al 2003, ELN 2017 Dohner et al 2017). MRD-negative response was required to be observed at or after morphological remission, and prior to relapse or disease progression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 25Uni of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Yale University School Of Medicine |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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Informed consent was obtained from each participant in writing before screening before any study specific procedure was performed.
This study was conducted in 28 centers across 10 countries with a total of 90 participants enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | MBG453 400 mg + Venetoclax +Azacitidine | Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study. |
| FG001 | MBG453 800 mg + Venetoclax +Azacitidine |
| 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 | Yes | No | No | Study Protocol | Dec 8, 2022 | Sep 25, 2025 |
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safety -run -in with escalating dose of MBG453 followed by expansion
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| Venetoclax | Drug | Tablet for oral administration |
|
| Azacitidine | Drug | Solution for subcutaneous injection or intravenous infusion |
|
| approx. 31 months |
| Measurable Residual Disease (MRD) - Negativity Rate in Participants With Best Overall Response (BOR) of CR/CRi and Evaluable MRD | MRD negativity rate was defined as the percentage of participants with MRD negativity, which was defined as an MRD negative sample (frequency of LAIP below 0.1%, as determined by Multi-parameter Flow Cytometry-Measurable residual disease (MFC-MRD) at Central Lab) in participant with remission (i.e., CR or CRi) as per investigator assessment (based on IWG Cheson et al 2003, ELN 2017 Dohner et al 2017). MRD-negative response was required to be observed at or after morphological remission, and prior to relapse or disease progression. | approx. 31 months |
| Duration of Complete Remission (CR) | The duration of CR is defined as the time from first achievement of CR to the first documented relapse or progressive disease or death due to any cause, whichever occurs first. The response assessment is as per investigator assessment based on IWG (Cheson et al 2003) and ELN 2017 (Dohner et al 2017). | approx. 31 months |
| Percentage of Participants Achieving a Complete Remission (CR) or Complete Remission With Incomplete Hematologic Blood Count Recovery (CRi) (CR/CRi Rate) | CR/CRi rate is defined as the percentage pf participants with best overall response of either complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) as per investigator assessment (based on IWG (Cheson et al 2003) and ELN 2017 (Dohner et al 2017)). | approx. 31 months |
| The Duration of Complete Remission (CR)/Complete Remission With Incomplete Blood Count Recovery (CRi) | The duration of CR/CRi is defined as the time from first achievement of CR or CRi to the first documented relapse or progressive disease or death due to any cause, whichever occurs first. The response assessment is as per investigator assessment based on IWG (Cheson et al 2003) and ELN 2017 (Dohner et al 2017). | approx. 31 months |
| Percentage of Participants Achieving a Complete Remission (CR) or Complete Remission With Partial Hematologic Blood Count Recovery (CRh) (CR/CRh Rate) | CR/CRh rate is defined as the percentage of participants with best overall response of either complete remission (CR) or complete remission with partial hematologic recovery (CRh) as per derivation based on ELN 2022 (Döhner et al 2022). | approx. 31 months |
| Duration of CR/CRh | The duration of CR/CRh is defined as the time from date of first documented CR or CRh to the date of first documented relapse or death due to any cause, whichever occurs first. The response assessment is as per derivation based on ELN 2022 (Döhner et al 2022). | approx. 31 months |
| Event Free Survival (EFS) | EFS is the time from start of treatment until death due to any cause, relapse from complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), or treatment failure, whichever occurs first. Treatment failure was defined as lack of reaching CR until Cycle 8 Day 1 or earlier permanent discontinuation from study without reaching CR, the time to treatment failure was then set to Day 1. | approx. 31 months |
| Overall Survival (OS) | OS is the time from start of treatment to death due to any cause. If a participant was not known to have died, then OS was censored at the latest date the participant was known to be alive (on or before the cut-off date). | approx. 31 months |
| Peak Serum Concentration (Cmax) of MBG453 | Cmax is the maximal concentration of MBG453. | Cycle 1 Day 8 (end of infusion) and Cycle 3 Day 8 (end of infusion), cycle = 28 days |
| Trough Serum Concentration (Cmin) MBG453 | Cmin is the minimum concentration of MBG453 (i.e., prior to the next dosing). | Day 8 of Cycle 1,2,3,6,9,12,18, 24 and through treatment completion, an average of 24 months |
| Trough Plasma Concentration (Cmin) Venetoclax | Trough concentration of venetoclax on treatment | 0 hr (Pre-dose) of Day 8 of Cycle 1, 3 and 6 ; Cycle =28 days |
| Anti-drug Antibody (ADA) Prevalence at Baseline and ADA Positive Participants On-treatment | Immunogenicity (IG) to MBG453 prior to MBG453 exposure. ADA prevalence (i.e., ADA-positive samples) is the number of ADA-positive samples among the number of participants with a non-missing sample. | at baseline, up to 150 days after last treatment, approx. 24 months |
| Rate of Participants Who Achieved Transfusion Independence From Baseline and While on Treatment | Percentage of participants having received no RBC/Platelets transfusions during at least 8 consecutive weeks. | approx. 31 months |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Uni Of Iowa Hospitals And Clinics | Iowa City | Iowa | 52242 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Memorial Sloan Kettering | New York | New York | 10017 | United States |
| Weill Cornell Medicine NY-Presb | New York | New York | 10021 | United States |
| Levine Cancer Insitute Carolinas Healthcare System | Charlotte | North Carolina | 28204 | United States |
| Duke Univ Medical Center | Durham | North Carolina | 27710 | United States |
| Chattanooga Onc And Hem Assoc PC | Chattanooga | Tennessee | 37404 | United States |
| MD Anderson Cancer Center University of Texas | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute Univ of Utah | Salt Lake City | Utah | 84112 0550 | United States |
| Novartis Investigative Site | Clayton | Victoria | 3168 | Australia |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3T 1E2 | Canada |
| Novartis Investigative Site | Paris | 75475 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Leipzig | Saxony | 04103 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Milan | MI | 20162 | Italy |
| Novartis Investigative Site | Roma | RM | 00133 | Italy |
| Novartis Investigative Site | Fukushima | Fukushima | 960 1295 | Japan |
| Novartis Investigative Site | Yamagata | Yamagata | 990 9585 | Japan |
| Novartis Investigative Site | Seoul | Seocho gu | 06591 | South Korea |
| Novartis Investigative Site | Barcelona | 08036 | Spain |
| Novartis Investigative Site | Madrid | 28009 | Spain |
| Novartis Investigative Site | Kaohsiung City | 83301 | Taiwan |
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study. |
| Did not enter post-treatment follow-up |
|
| Entered post-treatment follow-up |
|
| Entered survival follow-up |
|
| COMPLETED | Completed = completed treatment |
|
| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax).
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| ID | Title | Description |
|---|---|---|
| BG000 | MBG453 400 mg + Venetoclax +Azacitidine | Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study. |
| BG001 | MBG453 800 mg + Venetoclax +Azacitidine | Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study. |
| BG002 | 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, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body surface area (BSA) | BSA is a measurement of the total area of the skin of a human body, usually expressed in square meters (m²). It's a crucial parameter in various medical calculations, including drug dosages, fluid administration, and determining metabolic mass. BSA (m^2) at baseline is calculated as square root of (weight (kg) * height (cm)/3600) using weight at baseline and height at screening. | Mean | Standard Deviation | m^2 |
| ||||||||||||||
| ECOG performance status | Eastern Cooperative Oncology Group (ECOG) performance status scale is a widely used standard of care criteria used to assess the functional status of a patient with cancer to measure how the disease impacts thepatient's daily living abilities. This scale has a range from 0 - 5. The higher the grade, the worse the patient's abilities: 0 implies fully active, able to carry on all pre-disease performance without restriction and 5 implies death. | Number | Participants |
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| 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 | Incidence of Dose Limiting Toxicities (DLT)(Safety run-in Patients Only) | A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value considered by the Investigator to be at least possibily related to MBG453 as a single contributor or in combination with other component(s) of study treatment that occurs during the DLT observation period and meets any of the criteria as per protolcol. | The Dose-Determining Set (DDS) included all participants from the FAS enrolled in the safety run-in part who met the minimum exposure criterion and had sufficient safety evaluations or experienced a dose limiting toxicity (DLT) starting from Cycle 1 Day 8 to the end of Cycle 2. FAS comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). | Posted | Count of Participants | Participants | From Cycle 1 Day 8 to end of Cycle 2; Cycle =28 Days |
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| Primary | Percentage of Participants Achieving Complete Remission (CR) (CR Rate) | CR rate is defined as the percentage of participants achieving a complete remission (CR) as per investigator assessment (based on IWG Cheson et al 2003, ELN 2017 Dohner et al 2017). | All participants in the Full Analysis Set (FAS) and assigned to MBG453 at the 800 mg Q4W dose level. FAS comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). | Posted | Number | 95% Confidence Interval | Percentage of participants | approx. 31 months |
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| Secondary | Measurable Residual Disease (MRD) - Negativity Rate: Full Study Population | MRD negativity rate was defined as the percentage of participants with MRD negativity, which was defined as an MRD negative sample (frequency of LAIP below 0.1%, as determined by Multi-parameter Flow Cytometry-Measurable residual disease (MFC-MRD) at Central Lab) in participant with remission (i.e., CR or CRi) as per investigator assessment (based on IWG Cheson et al 2003, ELN 2017 Dohner et al 2017). MRD-negative response was required to be observed at or after morphological remission, and prior to relapse or disease progression. | The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). | Posted | Number | 95% Confidence Interval | Percentage of participants | approx. 31 months |
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| Secondary | Measurable Residual Disease (MRD) - Negativity Rate in Participants With Best Overall Response (BOR) of CR/CRi and Evaluable MRD | MRD negativity rate was defined as the percentage of participants with MRD negativity, which was defined as an MRD negative sample (frequency of LAIP below 0.1%, as determined by Multi-parameter Flow Cytometry-Measurable residual disease (MFC-MRD) at Central Lab) in participant with remission (i.e., CR or CRi) as per investigator assessment (based on IWG Cheson et al 2003, ELN 2017 Dohner et al 2017). MRD-negative response was required to be observed at or after morphological remission, and prior to relapse or disease progression. | All participants in FAS with the best overall response of CR or CRi and who are evaluable for MRD. The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). A participant is considered as evaluable for MRD if he/she had at least one post-baseline sample with MRD negative or MRD positive. | Posted | Number | 95% Confidence Interval | Percentage of participants | approx. 31 months |
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| Secondary | Duration of Complete Remission (CR) | The duration of CR is defined as the time from first achievement of CR to the first documented relapse or progressive disease or death due to any cause, whichever occurs first. The response assessment is as per investigator assessment based on IWG (Cheson et al 2003) and ELN 2017 (Dohner et al 2017). | The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). This was based on participants with best overall response of CR. | Posted | Median | 95% Confidence Interval | Months | approx. 31 months |
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| Secondary | Percentage of Participants Achieving a Complete Remission (CR) or Complete Remission With Incomplete Hematologic Blood Count Recovery (CRi) (CR/CRi Rate) | CR/CRi rate is defined as the percentage pf participants with best overall response of either complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) as per investigator assessment (based on IWG (Cheson et al 2003) and ELN 2017 (Dohner et al 2017)). | The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). | Posted | Number | 95% Confidence Interval | Percentage of participants | approx. 31 months |
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| Secondary | The Duration of Complete Remission (CR)/Complete Remission With Incomplete Blood Count Recovery (CRi) | The duration of CR/CRi is defined as the time from first achievement of CR or CRi to the first documented relapse or progressive disease or death due to any cause, whichever occurs first. The response assessment is as per investigator assessment based on IWG (Cheson et al 2003) and ELN 2017 (Dohner et al 2017). | The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). This was based on participants with best overall response of CR or CRi. | Posted | Median | 95% Confidence Interval | Months | approx. 31 months |
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| Secondary | Percentage of Participants Achieving a Complete Remission (CR) or Complete Remission With Partial Hematologic Blood Count Recovery (CRh) (CR/CRh Rate) | CR/CRh rate is defined as the percentage of participants with best overall response of either complete remission (CR) or complete remission with partial hematologic recovery (CRh) as per derivation based on ELN 2022 (Döhner et al 2022). | The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). | Posted | Number | 95% Confidence Interval | Percentage of participants | approx. 31 months |
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| Secondary | Duration of CR/CRh | The duration of CR/CRh is defined as the time from date of first documented CR or CRh to the date of first documented relapse or death due to any cause, whichever occurs first. The response assessment is as per derivation based on ELN 2022 (Döhner et al 2022). | The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). This was based on participants with best overall response of CR or CRh. | Posted | Median | 95% Confidence Interval | Months | approx. 31 months |
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| Secondary | Event Free Survival (EFS) | EFS is the time from start of treatment until death due to any cause, relapse from complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), or treatment failure, whichever occurs first. Treatment failure was defined as lack of reaching CR until Cycle 8 Day 1 or earlier permanent discontinuation from study without reaching CR, the time to treatment failure was then set to Day 1. | The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). | Posted | Median | 95% Confidence Interval | Months | approx. 31 months |
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| Secondary | Overall Survival (OS) | OS is the time from start of treatment to death due to any cause. If a participant was not known to have died, then OS was censored at the latest date the participant was known to be alive (on or before the cut-off date). | The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). | Posted | Median | 95% Confidence Interval | Months | approx. 31 months |
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| Secondary | Peak Serum Concentration (Cmax) of MBG453 | Cmax is the maximal concentration of MBG453. | The sabatolimab pharmacokinetic analysis set included all participants from the Safety Set who provided at least one evaluable sabatolimab PK concentration for the two populations. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/ml | Cycle 1 Day 8 (end of infusion) and Cycle 3 Day 8 (end of infusion), cycle = 28 days |
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| Secondary | Trough Serum Concentration (Cmin) MBG453 | Cmin is the minimum concentration of MBG453 (i.e., prior to the next dosing). | The sabatolimab pharmacokinetic analysis set included all participants from the Safety Set who provided at least one evaluable sabatolimab PK concentration for the two populations. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/ml | Day 8 of Cycle 1,2,3,6,9,12,18, 24 and through treatment completion, an average of 24 months |
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| Secondary | Trough Plasma Concentration (Cmin) Venetoclax | Trough concentration of venetoclax on treatment | The venetoclax pharmacokinetic analysis set included all participants from the Safety Set who provided at least one evaluable venetoclax PK concentration for the two populations. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | 0 hr (Pre-dose) of Day 8 of Cycle 1, 3 and 6 ; Cycle =28 days |
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| Secondary | Anti-drug Antibody (ADA) Prevalence at Baseline and ADA Positive Participants On-treatment | Immunogenicity (IG) to MBG453 prior to MBG453 exposure. ADA prevalence (i.e., ADA-positive samples) is the number of ADA-positive samples among the number of participants with a non-missing sample. | Immunogenicity Incidence Set includes all participants in the Immunogenicity prevalence set with a non-missing baseline ADA sample and at least one non-missing post-baseline ADA sample. The Immunogenicity prevalence set includes all participants in the Safety Set with a non-missing baseline ADA sample or at least one non-missing post-baseline ADA sample. | Posted | Count of Participants | Participants | No | at baseline, up to 150 days after last treatment, approx. 24 months |
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| Secondary | Rate of Participants Who Achieved Transfusion Independence From Baseline and While on Treatment | Percentage of participants having received no RBC/Platelets transfusions during at least 8 consecutive weeks. | The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). | Posted | Number | 95% Confidence Interval | Percentage of participants | approx. 31 months |
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| Post-Hoc | All Collected Deaths | Deaths were collected from treatment start until the end of the trial, approx. 31 months including post-treatment and survival follow-up period. | Clinical database population: All participants: participants who died during treatment and post-treatment. | Posted | Number | Participants | from randomization until end of trial, approx. 31 months. |
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Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
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 | MBG453 400 mg + Venetoclax +Azacitidine | Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study. | 3 | 5 | 4 | 5 | 5 | 5 |
| EG001 | MBG453 800 mg + Venetoclax +Azacitidine | Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study. | 56 | 85 | 67 | 85 | 85 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Immune-mediated pericarditis | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Anal inflammation | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Chills | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Malaise | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Splenic infection fungal | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Immune-mediated arthritis | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Chloroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Vascular dementia | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Axillary pain | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Catheter site irritation | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Chest pain | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Chills | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Injection site erythema | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Injection site reaction | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Injection site swelling | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Oedema | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Oedema genital | Reproductive system and breast disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Scalp haematoma | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e. data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-3000 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2024 | Sep 24, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723550 | sabatolimab |
| C579720 | venetoclax |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Unknown |
|
| ECOG performance status: 1 |
|
| ECOG performance status: 2 |
|
| ECOG performance status: 3 |
|
| Cardiac disorders - All grades |
|
| Cardiac disorders - Grades >= 3 |
|
|
|
|
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
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