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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06068868
Registration number
NCT06068868
Ethics application status
Date submitted
29/09/2023
Date registered
5/10/2023
Titles & IDs
Public title
Study to Evaluate Adverse Events and Movement of Intravenously (IV) Infused ABBV-787 in Adult Participants With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
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Scientific title
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-787 in Adult Subjects With Acute Myeloid Leukemia (AML)
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Secondary ID [1]
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2023-505233-27-00
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Secondary ID [2]
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M23-477
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-787
Experimental: ABBV-787 - Participants will receive increasing doses of ABBV-787 until the maximum tolerated dose (MTD) during the 3 year treatment period.
Treatment: Drugs: ABBV-787
Intravenous (IV) Infusion
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Intervention code [1]
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Treatment: Drugs
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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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Number of Participants with Adverse Events (AE)
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Assessment method [1]
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An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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Timepoint [1]
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Up to Approximately 3 Years
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Primary outcome [2]
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Maximum Tolerated Dose (MTD) Based on Dose-Limiting Toxicities (DLT)
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Assessment method [2]
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DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
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Timepoint [2]
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Up to approximately 28 Days
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Secondary outcome [1]
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Area Under the Plasma Concentration-time Curve (AUC) of ABBV-787
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Assessment method [1]
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AUC of ABBV-787.
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Timepoint [1]
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Up to Approximately 1 Year
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Secondary outcome [2]
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Maximum Observed Concentration (Cmax) of ABBV-787
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Assessment method [2]
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Cmax of ABBV-787.
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Timepoint [2]
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Up to Approximately 1 Year
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Secondary outcome [3]
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Time to Cmax (Tmax) of ABBV-787
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Assessment method [3]
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Tmax of ABBV-787.
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Timepoint [3]
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Up to Approximately 1 Year
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Secondary outcome [4]
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Half-life (t1/2) of ABBV-787
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Assessment method [4]
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t1/2 of ABBV-787.
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Timepoint [4]
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Up to Approximately 1 Year
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Secondary outcome [5]
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Total Antibody Concentration
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Assessment method [5]
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Total antibody concentration
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Timepoint [5]
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Up to Approximately 1 Year
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Secondary outcome [6]
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Plasma Concentrations of Unconjugated Bromodomain and Extra-terminal Domain (BET) Degrader Payload
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Assessment method [6]
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Plasma concentrations of unconjugated BET degrader payload.
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Timepoint [6]
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Up to Approximately 1 Year
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Secondary outcome [7]
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Antidrug Antibody (ADA)
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Assessment method [7]
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Incidence and concentration of anti-drug antibodies.
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Timepoint [7]
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Up to Approximately 1 Year
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Secondary outcome [8]
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Neutralizing Antibody (nAb)
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Assessment method [8]
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Incidence and concentration of neutralizing antibodies.
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Timepoint [8]
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Up to Approximately 1 Year
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Secondary outcome [9]
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Percentage of Participants Achieving Complete Remission (CR)
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Assessment method [9]
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CR is assessed by the European Leukemia Net (ELN). ELN defines refractory disease as the inability to attain complete remission (CR) or CR with incomplete hematologic recovery (CRi) after two courses of intensive induction treatment.
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Timepoint [9]
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Up to Approximately 1 Year
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Secondary outcome [10]
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Rate of Participants Achieving CR with partial hematologic recovery (CRh)
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Assessment method [10]
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Percentage of participants achieving CRh per ELN 2022.
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Timepoint [10]
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Up to Approximately 1 Year
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Secondary outcome [11]
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Rate of Participants Achieving CR with incomplete hematologic recovery (CRi)
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Assessment method [11]
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Percentage of participants achieving CRi per ELN 2022.
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Timepoint [11]
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Up to Approximately 1 Year
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Secondary outcome [12]
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Rate of Participants Achieving Composite CR (CR, CRh, or CRi)
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Assessment method [12]
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Composite CR is defined as the percentage of participants with composite CR per ELN 2022.
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Timepoint [12]
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Up to Approximately 1 Year
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Secondary outcome [13]
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Rate of Participants Achieving Partial Remission (PR)
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Assessment method [13]
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PR is defined as the percentage of participants with PR per ELN 2022.
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Timepoint [13]
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Up to Approximately 1 Year
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Secondary outcome [14]
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Duration of Response (DOR)
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Assessment method [14]
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DOR is defined for participants with CR, CRh, CRi, or PR as the time from the participant's initial response of CR, CRh, CRi, or PR per investigator review according to ELN 2022 criteria to disease progression or death of any cause, whichever occurs earlier.
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Timepoint [14]
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Up to Approximately 1 Year
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Secondary outcome [15]
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Number of Participants proceeding to hematopoietic stem cell transplant (HSCT)
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Assessment method [15]
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Number of participants proceeding to HSCT
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Timepoint [15]
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Up to Approximately 3 Years
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Secondary outcome [16]
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Event-free Survival (EFS)
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Assessment method [16]
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EFS is defined as the time from the date of the first study treatment to the date of treatment failure, or hematologic relapse from either CR, CRh, or CRi, or death from any cause, whichever occurs earlier.
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Timepoint [16]
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Up to Approximately 3 Years
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Secondary outcome [17]
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Relapse free survival (RFS)
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Assessment method [17]
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RFS is defined for participants achieving CR, CRh, or CRi as time from the date of achievement of remission (CR, CRh, or CRi) until the date of hematologic relapse or death from any cause.
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Timepoint [17]
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Up to Approximately 3 Years
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Secondary outcome [18]
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Overall survival (OS)
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Assessment method [18]
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OS is defined as time from first study treatment to death from any cause.
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Timepoint [18]
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Up to Approximately 3 Years
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Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Laboratory Criteria matching those outlined in the protocol.
* QT interval corrected for heart rate (QTc) <= 470 msec using Fridericia's correction, and no other clinically significant cardiac abnormalities.
* Documented diagnosis of non-promyelocytic acute myeloid leukemia (AML), per 2022 European Leukemia Net (ELN) criteria.
* Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) who have been treated with up to 3 prior lines of therapy and are refractory to or intolerant of all established AML therapies that are known to clearly provide clinical benefit at the judgement of the investigator.
* Must have a white blood cell (WBC) count < 25 × 10^9 /L prior to initiation of study drug (Note: Hydroxyurea or leukapheresis is permitted to meet this criterion and for use through Cycle 3 to control for hyperleukocytosis.).
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Minimum age
18
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
* Have received a CD33-targeting therapy within 3 months prior to the first dose of ABBV-787.
* Stem cell transplant within 3 months prior to first dose of study drug.
* Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-787.
* History of documented pneumonitis that required treatment with systemic steroids within the last 6 months, nor any evidence of active pneumonitis.
* Unresolved toxicity of Grade >= 2 from prior anticancer therapy, or to levels dictated in the eligibility criteria, with the exception of alopecia.
* Known active severe or poorly controlled acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Single group
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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
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
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Actual
13/11/2023
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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
20/10/2029
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre /ID# 253841 - Clayton
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Recruitment hospital [2]
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Peter MacCallum Cancer Ctr /ID# 252517 - Melbourne
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Connecticut
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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Maryland
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Country [5]
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United States of America
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State/province [5]
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Michigan
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Country [6]
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United States of America
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State/province [6]
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New York
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Country [7]
0
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United States of America
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State/province [7]
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Pennsylvania
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Country [8]
0
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United States of America
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State/province [8]
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Texas
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Country [9]
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United States of America
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State/province [9]
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Washington
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Country [10]
0
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United States of America
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State/province [10]
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Wisconsin
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Country [11]
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Israel
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State/province [11]
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Tel-Aviv
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Country [12]
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Israel
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State/province [12]
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Jerusalem
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Country [13]
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Japan
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State/province [13]
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Chiba
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Country [14]
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Japan
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State/province [14]
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Yamagata
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Country [15]
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Korea, Republic of
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State/province [15]
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Seoul Teugbyeolsi
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Country [16]
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Korea, Republic of
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State/province [16]
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Seoul
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Acute myeloid leukemia (AML) is the second most common type of leukemia diagnosed in adults and children, but most cases occur in adults. This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). Adverse events and maximum tolerated dose (MTD) of ABBV-787 will be assessed. ABBV-787 is an investigational drug being developed for the treatment of AML. Participants will receive ABBV-787 in escalating doses until the maximum tolerated dose (MTD) is determined. Approximately 60 adult participants with a diagnosis of AML will be enrolled worldwide. Participants will receive intravenous (IV) infusions of ABBV-787 during the approximately 3 year duration a participant is followed. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.
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Trial website
https://clinicaltrials.gov/study/NCT06068868
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Country
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Phone
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844-663-3742
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Fax
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Email
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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)?
No
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No/undecided IPD sharing reason/comment
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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/NCT06068868