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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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A Phase Ib/II, Multicenter, Single Arm, Open-Label Study, To Evaluate the Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab Combination for Maintenance Treatment in Subjects with Acute Myeloid Leukemia- The BATTLE Study
The main goal of this clinical trial is to assess the safety and tolerability of the treatment combination of BL-8040 and Atezolizumab as Maintenance Treatment in Subjects with Acute Myeloid Leukemia.
Additional objectives are:
Assessment of the effect of combination of BL-8040 and Atezolizumab on relapse free survival (RFS) Assessment whether the treatment combination of BL-8040 and Atezolizumab can reduce the Minimal Residual Disease (MRD) as compared to baseline Assessment of the Overall Survival (OS) time in subjects treated with the combination of BL-8040 and Atezolizumab for maintenance Assessment of the Event Free Survival (EFS) time in subjects treated with the combination of BL-8040 and Atezolizumab for maintenance
This study will assess the safety and effectiveness of a combination of BL-8040 and atezolizumab to find out what is the Safety, Tolerability and Efficacy of this treatment combination for maintenance treatment in subjects with acute myeloid leukemia.
This is a single arm, open label, Phase Ib/II study in which eligible subjects will receive maintenance treatment consisting of intravenous (IV) infusion of Atezolizumab on Day 2 of each 21-day cycle and subcutaneous (SC) injections of BL-8040 on Days 1, 2 and 3 of each 21-day cycle. Cycles will be repeated for up to 2 years (a maximum of 34 treatment cycles), until early discontinuation for any reason or until disease relapse, whichever comes first.
Approximately 60 patients will take part at multiple centers worldwide.
The duration of the treatment period of the study will be up to 2 years and will be followed by one year safety follow up. The study will consist of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Treatment Single Arm | Experimental | Combination Treatment of BL-8040 with Atezolizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL-8040 | Drug | Subjects will receive maintenance treatment consisting of subcutaneous (SC) injections of BL-8040 on Days 1, 2 and 3 of each 21-day cycle. Cycles will be repeated for up to 2 years (a maximum of 34 treatment cycles), until early discontinuation for any reason or until disease relapse, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Free Survival | Relapse Free Survival measured from the time of Complete Remission to the relapse or death from any cause whichever comes first | Up to 5 years |
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Inclusion Criteria:
AML confirmed subjects aged ≥ 60 years who have achieved complete remission (CR or CRi) after induction/consolidation Ara-C based therapy, that have MRD positive status and are not planned for stem cell transplantation.
Exclusion Criteria:
Subjects diagnosed with acute promyelocytic leukemia or with extramedullary AML or subjects who have achieved CR or CRi following treatment for AML. Subjects who have received treatment with hypomethylating agents.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas - Md Anderson Cancer Center - Leukemia Center | Houston | Texas | 77030 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination Treatment Single Arm | Combination Treatment of BL-8040 with Atezolizumab BL-8040: Subjects will receive maintenance treatment consisting of subcutaneous (SC) injections of BL-8040 on Days 1, 2 and 3 of each 21-day cycle. Cycles will be repeated for up to 2 years (a maximum of 34 treatment cycles), until early discontinuation for any reason or until disease relapse, whichever comes first. Atezolizumab: Subjects will receive maintenance treatment consisting of intravenous (IV) infusion of Atezolizumab on Day 2 of each 21-day cycle. Cycles will be repeated for up to 2 years (a maximum of 34 treatment cycles), until early discontinuation for any reason or until disease relapse, whichever comes first. |
| 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 | Jan 27, 2019 |
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| Atezolizumab | Drug | Subjects will receive maintenance treatment consisting of intravenous (IV) infusion of Atezolizumab on Day 2 of each 21-day cycle. Cycles will be repeated for up to 2 years (a maximum of 34 treatment cycles), until early discontinuation for any reason or until disease relapse, whichever comes first. |
|
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| Medical College of Wisconsin/Froedtert Hospital |
| Milwaukee |
| Wisconsin |
| 53226 |
| United States |
| Fakultni Nemocnice Brno / University Hospital Brno Interni Hematologicka A Onkologicka Klinika / Internal Hematology and Oncology Clinic | Brno | Czechia |
| Fakultni Nemocnice Ostrava (Fno) / University Hospital Ostrava Klinika Hematoonkologie / Hematooncology Clinic | Ostrava | Czechia |
| Fakultni Nemocnice Kralovske Vinohrady Fnkv / University Hospital Kralovske Vinohrady Internà Hematologická Klinika Fnkv / Internal Hematology Clinic | Prague | Czechia |
| Rambam Medical Center | Haifa | Israel |
| Shaarei Tzedek Medical Center | Jerusalem | Israel |
| Wojewódzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopernika W Lodzi | Lodz | Poland |
| Národný Onkologický Ústav / National Cancer Institute, Oddelenie Onkohematológie Ii / Department of Oncohematology Ii | Bratislava | Slovakia |
| Hospital San Pedro de Alcántara de Cáceres | Cáceres | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Universitario La Fe de Valencia | Valencia | Spain |
| COMPLETED |
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| NOT COMPLETED |
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All patients who were eligible to the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination Treatment of BL-8040 With Atezolizumab | Combination Treatment of BL-8040 with Atezolizumab BL-8040: Subjects will receive maintenance treatment consisting of subcutaneous (SC) injections of BL-8040 on Days 1, 2 and 3 of each 21-day cycle. Cycles will be repeated for up to 2 years (a maximum of 34 treatment cycles), until early discontinuation for any reason or until disease relapse, whichever comes first. Atezolizumab: Subjects will receive maintenance treatment consisting of intravenous (IV) infusion of Atezolizumab on Day 2 of each 21-day cycle. Cycles will be repeated for up to 2 years (a maximum of 34 treatment cycles), until early discontinuation for any reason or until disease relapse, whichever comes first. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | 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 | Relapse Free Survival | Relapse Free Survival measured from the time of Complete Remission to the relapse or death from any cause whichever comes first | All eligible patients who received at least 1 dose of study medications | Posted | Up to 5 years |
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Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combination Treatment of BL-8040 With Atezolizumab | Combination Treatment of BL-8040 with Atezolizumab BL-8040: Subjects will receive maintenance treatment consisting of subcutaneous (SC) injections of BL-8040 on Days 1, 2 and 3 of each 21-day cycle. Cycles will be repeated for up to 2 years (a maximum of 34 treatment cycles), until early discontinuation for any reason or until disease relapse, whichever comes first. Atezolizumab: Subjects will receive maintenance treatment consisting of intravenous (IV) infusion of Atezolizumab on Day 2 of each 21-day cycle. Cycles will be repeated for up to 2 years (a maximum of 34 treatment cycles), until early discontinuation for any reason or until disease relapse, whichever comes first. | 0 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical & Medical Affairs | BioLineRx Ltd | +972-8-642-9100 | clinicaltrials@biolinerx.com |
| Aug 14, 2024 |
| Prot_SAP_000.pdf |
| 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 |
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| ID | Term |
|---|---|
| C477728 | 4-fluorobenzoyl-TN-14003 |
| C000594389 | atezolizumab |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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