The most common types of acute leukaemia are acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). AML is a heterogenous clonal disorder of haemopoietic progenitor cells and the most common and severe malignant leukemia in adults and is responsible for the highest mortality from leukemia. ALL is a neoplasm characterized by the growth of malignant lymphoblasts of the B or T lineage, leading to an inhibition of proliferation of the normal blood cell lineages. The primary objectives of this study are investigating the safety, tolerability, and the MTD of LBS-007. The secondary objectives are to assess the efficacy and to determine the pharmacokinetics (PK) of LBS-007. The exploratory objective is to study and correlate the changes in surrogate biomarkers in response to treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Open Label.
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGRobert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
NOT_YET_RECRUITINGThe University of Kansas Hospital
Fairway, Kansas, United States
RECRUITINGSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
RECRUITINGUNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGWollongong Private Hospital
Wollongong, New South Wales, Australia
COMPLETEDPindara Private Hospital
Benowa, Queensland, Australia
COMPLETEDThe Royal Adelaide Hospital
Adelaide, South Australia, Australia
RECRUITINGThe Alfred Hospital
Melbourne, Victoria, Australia
ACTIVE_NOT_RECRUITINGHollywood Private Hospital
Nedlands, Washington, Australia
WITHDRAWN...and 7 more locations
Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.
Time frame: From baseline through 28 days after end of last treatment cycle (up to 12 months)
Recommended Phase 2 Dose (RP2D) of LBS-007 in the subject population.
Time frame: From baseline through 28 days after end of last treatment cycle (up to 12 months)
Maximum Plasma Concentration (Cmax) of LBS-007 in plasma.
Time frame: Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.
Time to Maximum Plasma Concentration (Tmax) of LBS-007 in plasma.
Time frame: Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.
Area under the drug concentration-time curve (AUC) of LBS-007 in plasma.
Time frame: Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.
Efficacy of LBS-007 assessed by bone marrow and peripheral blood.
Objective response rate (ORR): Defined for AML as complete response (CR), CR with partial hematological recovery (CRh), CR with incomplete hematological recovery (CRi), morphologic leukemia free state (MLFS), or partial response (PR) as assessed by bone marrow and peripheral blood Defined for ALL as CR, CRh, CRi, or MLFS
Time frame: From baseline through 28 days after end of last treatment cycle (up to 12 months)
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