Trial Outcomes & Findings for Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML) (NCT NCT03154827)

NCT ID: NCT03154827

Last Updated: 2024-09-05

Results Overview

Relapse Free Survival measured from the time of Complete Remission to the relapse or death from any cause whichever comes first

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: Up to 5 years
• Results posted on: 2024-09-05

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML)

Baseline characteristics by cohort

Measure	Combination Treatment of BL-8040 With Atezolizumab n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Czechia	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: All eligible patients who received at least 1 dose of study medications

Relapse Free Survival measured from the time of Complete Remission to the relapse or death from any cause whichever comes first

Outcome measures

Outcome data not reported

Adverse Events

Combination Treatment of BL-8040 With Atezolizumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure

Combination Treatment of BL-8040 With Atezolizumab n=1 participants at risk 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.

Infections and infestations Bronchiolitis

100.0% 1/1 • Number of events 1 • Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year

Other adverse events

Measure	Combination Treatment of BL-8040 With Atezolizumab n=1 participants at risk 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.
Skin and subcutaneous tissue disorders Rash	100.0% 1/1 • Number of events 2 • Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year
Gastrointestinal disorders Vomiting	100.0% 1/1 • Number of events 1 • Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 2 • Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year
Respiratory, thoracic and mediastinal disorders Cough	100.0% 1/1 • Number of events 1 • Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year
Respiratory, thoracic and mediastinal disorders Rhinitis	100.0% 1/1 • Number of events 1 • Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year
Metabolism and nutrition disorders Decreased appetite	100.0% 1/1 • Number of events 1 • Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year
Skin and subcutaneous tissue disorders Dermatitis allergic	100.0% 1/1 • Number of events 1 • Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year
Psychiatric disorders Anxiety	100.0% 1/1 • Number of events 1 • Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year
Gastrointestinal disorders Constipation	100.0% 1/1 • Number of events 1 • Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year
Infections and infestations Bronchitis	100.0% 1/1 • Number of events 1 • Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year
General disorders Pyrexia	100.0% 1/1 • Number of events 2 • Adverse Events were assessed from study start upon informed consent signature until end of study which is approximately 1 year

Additional Information

VP Clinical & Medical Affairs

BioLineRx Ltd

Phone: +972-8-642-9100

Email: clinicaltrials@biolinerx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place