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

Part of paid clinical trials in Houston, Texas.

Sponsor
BioLineRx, Ltd.
Study ID
NCT03154827
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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

Key Dates

First listed
May 16, 2017
Start date
Jan 8, 2018
Status verified
Aug 2024
Primary completion
Apr 1, 2020
Completion
Apr 1, 2020

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Treatment Single Arm
    Combination Treatment of BL-8040 with Atezolizumab

Primary Outcome Measure

Relapse Free Survival [ Time Frame: Up to 5 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Texas - Md Anderson Cancer Center - Leukemia CenterHoustonTexas77030-
Medical College of Wisconsin/Froedtert HospitalMilwaukeeWisconsin53226-

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The University of Texas - Md Anderson Cancer Center - Leukemia Center· Houston, TXMedical College of Wisconsin/Froedtert Hospital· Milwaukee, WI

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