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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07109219
Registration number
NCT07109219
Ethics application status
Date submitted
7/07/2025
Date registered
7/08/2025
Date last updated
7/08/2025
Titles & IDs
Public title
Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia
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Scientific title
A Modular Phase I/II, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AZD4512 Monotherapy or in Combination With Anticancer Agent(s) in Participants With Acute Lymphoblastic Leukemia
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Secondary ID [1]
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2025-522372-93-00
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Secondary ID [2]
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D9891C00001
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Universal Trial Number (UTN)
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Trial acronym
ALLight
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
B-cell Acute Lymphoblastic Leukemia (B-ALL)
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - AZD4512 monotherapy
Experimental: Module 1 Dose Escalation - Module 1 will evaluate escalating doses of AZD4512 as monotherapy to determine the maximum tolerated dose (MTD) and/or doses of AZD4512 for subsequent evaluation in Module 2 (dose optimization), in participants with relapsed/refractory (R/R) Philadelphia chromosome positive (Ph\[+\]) and negative (Ph\[-\]) B-ALL, R/R as defined by National Comprehensive Cancer Network (NCCN) guidelines, or with measurable residual disease (MRD) = 1% to = 5% after failing or relapsing after standard of care therapies.
Experimental: Module 2 Dose Optimization - Module 2 will randomize participants with R/R (as defined by NCCN guidelines) Ph(-) BALL only across 2 to 3 dose levels identified in Module 1 to receive AZD4512 monotherapy for further exploration of the doses. The aim of Module 2 is to identify the recommended Phase 2 dose (RP2D) of AZD4512 monotherapy, evaluate the efficacy and further define the safety profile of AZD4512.
Other interventions: AZD4512 monotherapy
Patients will receive AZD4512 as monotherapy via intravenous infusion. AZD4512 is an antibody-drug conjugate targeting CD22
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Module 1 (Dose Escalation): Number of participants with dose-limiting toxicities (DLTs).
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Assessment method [1]
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DLTs are dose-limiting toxicities as defined in the study protocol.
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Timepoint [1]
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From first dose up to 21 days (DLT period).
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Primary outcome [2]
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Module 1 (Dose Escalation): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs)
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Assessment method [2]
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Assessed by the CTCAE criteria version 5.0
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Timepoint [2]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Primary outcome [3]
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Module 1 (Dose Escalation): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEs
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Assessment method [3]
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Timepoint [3]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Primary outcome [4]
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Module 1 (Dose Escalation): Number of participants with clinically significant changes in laboratory values, ECGs, performance status, and vital signs
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Assessment method [4]
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Timepoint [4]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Primary outcome [5]
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Module 2 (Dose Optimization): Overall response rate (ORR) in participants with R/R Ph(-) B-ALL
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Assessment method [5]
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To evaluate the efficacy based on NCCN response criteria, measured by ORR (CR/CRh)
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Timepoint [5]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Primary outcome [6]
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Module 2 (Dose Optimization): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs)
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Assessment method [6]
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Assessed by the CTCAE criteria version 5.0
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Timepoint [6]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Primary outcome [7]
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Module 2 (Dose Optimization): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEs
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Assessment method [7]
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Timepoint [7]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Primary outcome [8]
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Module 2 (Dose Optimization): Number of participants with clinically significant changes in laboratory values, ECGs, performance status, and vital signs
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Assessment method [8]
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Timepoint [8]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [1]
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Module 1 (Dose Escalation): Plasma PK parameters of AZD4512
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Assessment method [1]
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To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL.
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Timepoint [1]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [2]
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Module 1 (Dose Escalation): Total antibody and total unconjugated payload
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Assessment method [2]
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To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL.
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Timepoint [2]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [3]
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Module 1 (Dose Escalation): Area Under Curve (AUC)
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Assessment method [3]
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To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL.
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Timepoint [3]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [4]
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Module 1 (Dose Escalation): Peak Plasma Concentration (Cmax)
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Assessment method [4]
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To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL.
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Timepoint [4]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [5]
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Module 1 (Dose Escalation): Time to max concentration (Tmax)
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Assessment method [5]
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To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL.
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Timepoint [5]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [6]
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Module 1 (Dose Escalation): Half life (T1/2)
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Assessment method [6]
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To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL.
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Timepoint [6]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [7]
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Module 1 (Dose Escalation): Clearance (CL)
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Assessment method [7]
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To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL.
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Timepoint [7]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [8]
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Module 1 (Dose Escalation): Volume of distribution (Vz)
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Assessment method [8]
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To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL.
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Timepoint [8]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [9]
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Module 1 (Dose Escalation): Number and percentage of participants who develop anti-drug antibodies (ADAs)
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Assessment method [9]
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To determine the immunogenicity of AZD4512 as monotherapy in participants with R/R B-ALL.
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Timepoint [9]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [10]
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Module 1 (Dose Escalation): Objective Response Rate (ORR): proportion of participants with CR or CRh
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Assessment method [10]
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To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] as defined by NCCN guidelines
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Timepoint [10]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [11]
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Module 1 (Dose Escalation): Composite Complete Remission (CRc) rate: proportion of participants with CR, CRh, or CRi
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Assessment method [11]
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To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] as defined by NCCN guidelines
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Timepoint [11]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [12]
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Module 1 (Dose Escalation): Complete Remission (CR) rate
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Assessment method [12]
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0
To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] as defined by NCCN guidelines
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Timepoint [12]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [13]
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Module 1 (Dose Escalation): Time to Response (TTR)
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Assessment method [13]
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0
To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] as defined by NCCN guidelines
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Timepoint [13]
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0
From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [14]
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Module 1 (Dose Escalation): Duration of Response (DoR)
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Assessment method [14]
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* To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] as defined by NCCN guidelines * To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] with MRD = 1% to = 5%
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Timepoint [14]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [15]
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Module 1 (Dose Escalation): Event-Free Survival (EFS)
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Assessment method [15]
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* To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] as defined by NCCN guidelines * To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] with MRD = 1% to = 5%
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Timepoint [15]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [16]
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Module 1 (Dose Escalation): Overall Survival (OS)
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Assessment method [16]
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* To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] as defined by NCCN guidelines * To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] with MRD = 1% to = 5%
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Timepoint [16]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [17]
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Module 1 (Dose Escalation): Percentage of participants who receive subsequent allogeneic hematopoietic stem cell transplant (HSCT)
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Assessment method [17]
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* To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] as defined by NCCN guidelines * To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] with MRD = 1% to = 5%
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Timepoint [17]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [18]
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Module 1 (Dose Escalation): MRD conversion rate: proportion of participants with conversion to MRD negativity (<10-4)
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Assessment method [18]
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To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] with MRD = 1% to = 5%
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Timepoint [18]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [19]
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0
Module 1 (Dose Escalation): Time to MRD conversion
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Assessment method [19]
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0
To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-) and Ph(+)\] with MRD = 1% to = 5%
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Timepoint [19]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [20]
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Module 2 (Dose Optimization): Complete Remission (CR) rate
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Assessment method [20]
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0
To evaluate the efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\] as defined by NCCN guidelines
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Timepoint [20]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [21]
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Module 2 (Dose Optimization):Composite Complete Remission (CRc) rate: proportion of participants with CR, CRh, or CRi
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Assessment method [21]
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0
To evaluate the efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\] as defined by NCCN guidelines
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Timepoint [21]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [22]
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Module 2 (Dose Optimization):Time to Response (TTR)
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Assessment method [22]
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0
To evaluate the efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\] as defined by NCCN guidelines
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Timepoint [22]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [23]
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Module 2 (Dose Optimization): Duration of Response (DoR)
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Assessment method [23]
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0
To evaluate the efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\] as defined by NCCN guidelines
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Timepoint [23]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [24]
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Module 2 (Dose Optimization):Event-Free Survival (EFS)
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Assessment method [24]
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0
To evaluate the efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\] as defined by NCCN guidelines
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Timepoint [24]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [25]
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Module 2 (Dose Optimization): Overall Survival (OS)
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Assessment method [25]
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0
To evaluate the efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\] as defined by NCCN guidelines
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Timepoint [25]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [26]
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Module 2 (Dose Optimization): Percentage of participants who receive subsequent allogeneic hematopoietic stem cell transplant (HSCT)
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Assessment method [26]
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To evaluate the efficacy of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\] as defined by NCCN guidelines
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Timepoint [26]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [27]
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Module 2 (Dose Optimization): MRD-negative CR rate, CR/CRh (ORR), CR/CRi/CRh (CRc) rate
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Assessment method [27]
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0
To evaluate the impact of AZD4512 on MRD as assessed by NGS (central)
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Timepoint [27]
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From date of first dose of AZD4512 up until end of study, up to 38 months
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Secondary outcome [28]
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0
Module 2 (Dose Optimization): Plasma PK parameters of AZD4512
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Assessment method [28]
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0
To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\]
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Timepoint [28]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [29]
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0
Module 2 (Dose Optimization): total antibody and total unconjugated payload
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Assessment method [29]
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0
To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\]
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Timepoint [29]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [30]
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Module 2 (Dose Optimization): Area Under Curve (AUC)
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Assessment method [30]
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0
To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\]
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Timepoint [30]
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0
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [31]
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0
Module 2 (Dose Optimzation): Peak Plasma Concentration (Cmax)
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Assessment method [31]
0
0
To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\]
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Timepoint [31]
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0
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [32]
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0
Module 2 (Dose Optimization): Time to max concentration (Tmax)
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Assessment method [32]
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0
To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\]
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Timepoint [32]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [33]
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0
Module 2 (Dose Optimization): Half life (T1/2)
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Assessment method [33]
0
0
To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\]
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Timepoint [33]
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0
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [34]
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Module 2 (Dose Optimization): Clearance (CL)
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Assessment method [34]
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0
To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\]
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Timepoint [34]
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0
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [35]
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0
Module 2 (Dose Optimization): Volume of distribution (Vz)
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Assessment method [35]
0
0
To characterize the PK of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\]
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Timepoint [35]
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0
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Secondary outcome [36]
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0
Module 2 (Dose Optimization): Summary of of pre-existing and treatment induced ADAs for AZD4512 (positive or negative, titers)
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Assessment method [36]
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0
To determine the immunogenicity of AZD4512 as monotherapy in participants with R/R B-ALL \[Ph(-)\]
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Timepoint [36]
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From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Eligibility
Key inclusion criteria
* 1. Age:
* 16 years old in Module 1
* 12 years old in Module 2
2. Diagnosis: Diagnosis of B-ALL WHO (WHO-HAEM5)
* Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts > 5% or reappearance of blasts in PB) or R/R with MRD = 1% to =5%
* The nº of enrolled participants with MRD = 1 to = 5% will be limited to 25% of the DE cohort
* Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL - R/R or with MRD = 1% to =5%
* Backfill of Module 1 and Module 2 (DO): R/R Ph(-) B-ALL (BM blasts >5%)
3. Performance status (ECOG = 2; KPS = 50; LPS = 50)
4. Peripheral lymphoblast count < 10,000/µL (may receive cytoreduction prior to C1D1 per protocol-specified criteria)
5. At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available
* Ph+ B-ALL (Module 1 DE only): intolerant to or have contraindications to TKI therapy or R/R disease despite treatment with at least 2 prior TKIs or at least one 3rd generation TKI
6. Prior DLI >4 weeks, prior cell therapy or autoHSCT >8 weeks, alloHSCT >12 weeks
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Burkitt lymphoma and leukemia
2. Isolated extramedullary disease; Active testicular or CNS (> CNS1) involvement
3. Unresolved non-heme toxicities Grade = 2 (except alopecia, stable Grade = 2 neuropathy, vitiligo, endocrine disorders controlled with therapy)
4. History of drug-induced non-infectious ILD/pneumonitis requiring oral or IV steroids or supplemental oxygen or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
5. Prior/concomitant therapy
* Cytotoxic treatment within 14 days (except ALL maintenance medications or cytoreduction)
* Biologic (immuno-oncology) treatment within 28 days or 5 half-lives (whichever is shorter)
* Non-CNS radiation within 2 weeks & CNS radiation within 4 weeks
* Medications known to prolong QTc and/or associated with Torsades de Pointes within 21 days or 5 half-lives (whichever is longer)
* Strong inhibitors of CYP 3A4 within 21 days or 5 half-lives (whichever is longer)
* Investigational agents or study interventions in the last 30 days
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
31/10/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
3/07/2028
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Actual
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Sample size
Target
83
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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0
Research Site - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Iowa
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Tennessee
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Texas
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Country [5]
0
0
Canada
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State/province [5]
0
0
Ontario
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Country [6]
0
0
Japan
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State/province [6]
0
0
Bunkyo City
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Country [7]
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South Korea
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Seoul
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Spain
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Barcelona
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Spain
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Salamanca
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Spain
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Santander
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Spain
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Valencia
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Taiwan
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Taichung
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Taiwan
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Taipei
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United Kingdom
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London
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Commercial sector/industry
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Fortrea
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Ethics approval
Ethics application status
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Summary
Brief summary
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
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Trial website
https://clinicaltrials.gov/study/NCT07109219
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Contacts
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Contact person for public queries
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AstraZeneca Clinical Study Information Center
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1-877-240-9479
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07109219
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