A Phase 1/2 interventional study of BL-8040 and Atezolizumab in Acute Myeloid Leukemia, sponsored by BioLineRx, Ltd.. Terminated at 12 sites in 6 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by BioLineRx, Ltd. · Phase 1/2, Interventional, and Treatment
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:
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 1 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →BioLineRx, Ltd. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Combination Treatment of BL-8040 with Atezolizumab
Drug: BL-8040 · Drug: Atezolizumab
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.
Also known as: Motixafortide
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.
Also known as: Tecentriq
Relapse Free Survival
Relapse Free Survival measured from the time of Complete Remission to the relapse or death from any cause whichever comes first
Time frame: Up to 5 years
| Milestone | Combination Treatment Single Arm |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
Relapse Free Survival measured from the time of Complete Remission to the relapse or death from any cause whichever comes first
No measurements were reported for this outcome.
Collected over Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Combination Treatment of BL-8040 With Atezolizumab | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Event | Combination Treatment of BL-8040 With Atezolizumab |
|---|---|
| BronchiolitisInfections and infestations | 1/1 |
| Event | Combination Treatment of BL-8040 With Atezolizumab |
|---|---|
| RashSkin and subcutaneous tissue disorders | 1/1 |
| VomitingGastrointestinal disorders | 1/1 |
| NauseaGastrointestinal disorders | 1/1 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/1 |
| RhinitisRespiratory, thoracic and mediastinal disorders | 1/1 |
| Decreased appetiteMetabolism and nutrition disorders | 1/1 |
| Dermatitis allergicSkin and subcutaneous tissue disorders | 1/1 |
| AnxietyPsychiatric disorders | 1/1 |
| ConstipationGastrointestinal disorders | 1/1 |
| BronchitisInfections and infestations | 1/1 |
All patients who were eligible to the study
| Age, Categorical(Participants) | Combination Treatment of BL-8040 With Atezolizumab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Combination Treatment of BL-8040 With Atezolizumab |
|---|---|
| Female | 1 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Combination Treatment of BL-8040 With Atezolizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Combination Treatment of BL-8040 With Atezolizumab |
|---|---|
| Czechia | 1 |
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BioLineRx, Ltd.