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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05079230
Registration number
NCT05079230
Ethics application status
Date submitted
4/10/2021
Date registered
15/10/2021
Titles & IDs
Public title
Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia
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Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
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Secondary ID [1]
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2021-003434-36
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Secondary ID [2]
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GS-US-590-6154
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Universal Trial Number (UTN)
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Trial acronym
ENHANCE-3
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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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0
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Leukaemia - Acute leukaemia
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Cancer
0
0
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0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
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0
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Magrolimab
Treatment: Drugs - Venetoclax
Treatment: Drugs - Azacitidine
Treatment: Drugs - Magrolimab Placebo
Experimental: Magrolimab + Venetoclax + Azacitidine - Participants will receive
* magrolimab: 1 mg/kg priming dose on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses and every 2 weeks thereafter
* venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter
* azacitidine: 75 mg/m\^2 on Days 1-7 or Days 1-5 and 8-9 of each cycle
Each cycle is 28 days.
Placebo comparator: Magrolimab Placebo + Venetoclax + Azacitidine - Participants will receive
* magrolimab placebo: Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter
* venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter
* azacitidine: 75 mg/m\^2 on Days 1-7 or Days 1-5 and 8-9 of each cycle
Each cycle is 28 days.
Treatment: Drugs: Magrolimab
Administered intravenously (IV)
Treatment: Drugs: Venetoclax
Tablets administered orally
Treatment: Drugs: Azacitidine
Administered according to region-specific drug labeling, either subcutaneously (SC) or intravenously (IV)
Treatment: Drugs: Magrolimab Placebo
Administered intravenously (IV)
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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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Overall Survival (OS)
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Assessment method [1]
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OS is measured from the date of randomization to the date of death from any cause.
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Timepoint [1]
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Randomization up to death or end of study (up to 5 years) whichever occurs first
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Secondary outcome [1]
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Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh)
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Assessment method [1]
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The CR + CRh rate is the proportion of participants who achieve a CR (including CRMRD- and complete remission with positive or unknown minimal residual disease (CRMRD+/unk)) or CRh as defined by CR with partial platelet and absolute neutrophil count recovery within 6 cycles of treatment while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT).
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Timepoint [1]
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Up to 7 months
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Secondary outcome [2]
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Rate of Complete Remission (CR)
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Assessment method [2]
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CR is defined as the proportion of the participants who achieve CR within 6 cycles of treatment as determined by the investigator while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT)
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Timepoint [2]
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Up to 7 months
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Secondary outcome [3]
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Event-Free Survival (EFS)
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Assessment method [3]
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EFS is defined as time from the date of randomization to the earliest date of the documented relapse from CR, treatment failure (defined as failure to achieve CR within 6 cycles of treatment), or death from any cause.
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Timepoint [3]
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Randomization up to end of study (up to 5 years)
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Secondary outcome [4]
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Duration of CR + CRh in Participants who achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh)
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Assessment method [4]
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The duration of CR + CRh is measured from the time the assessment criteria are first met for CR (including CRMRD- and CRMRD+/unk) or CRh within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT).
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Timepoint [4]
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0
Up to 5 years
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Secondary outcome [5]
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Duration of Complete Remission (DCR) in Participants who achieved Complete Remission (CR)
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Assessment method [5]
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The DCR is measured from the time the assessment criteria are first met for CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT).
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Timepoint [5]
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0
Up to 5 years
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Secondary outcome [6]
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Rate of CR/Complete Remission With Partial Hematologic Recovery Without Minimal Residual Disease (CRhMRD-)
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Assessment method [6]
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The CR/CRhMRD- rate is the proportion of participants who achieve a CRMRD- or CRhMRD- within 6 cycles of treatment while on study prior to initiation of any new anti-AML therapy or SCT.
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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Rate of Complete Remission Without Minimal Residual Disease (CRMRD-)
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Assessment method [7]
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The CRMRD- rate is the proportion of participants who achieve a CRMRD- within 6 cycles of treatment.
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Timepoint [7]
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Up to 5 years
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Secondary outcome [8]
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Transfusion Independence Conversion Rate
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Assessment method [8]
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The transfusion independence conversion rate includes both red blood cell (RBC) transfusion independence rate and platelet transfusion independence rate. The RBC transfusion independence conversion rate is the proportion of participants who have a 56-day or longer period with no RBC or whole blood transfusions at any time between the date of first dose of study treatment and discontinuation of study treatment among all participants who are RBC transfusion dependent at baseline. The platelet transfusion independence conversion rate is the proportion of participants who have a 56-day or longer period with no platelet transfusions at any time between the date of first dose of study treatment and discontinuation of study treatment among all participants who are platelet transfusion dependent at baseline.
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Timepoint [8]
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First dose date up to End of Treatment (EOT) (up to 5 years)
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Secondary outcome [9]
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Time to First Deterioration (TTD) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale
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Assessment method [9]
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The TTD on the EORTC QLQ-C30 GHS/QoL scale is defined as time from the date of randomization to the time a patient experienced at least 1 threshold value deterioration from baseline or death, whichever is earlier. Questionnaire includes 30 questions resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 GHS/QoL scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). After linear transformation, all scales and single item measures range in score from 0-100. Higher score on GHS/QoL scale means better GHS/QoL.
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Timepoint [9]
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Randomization up to end of study (up to 5 years)
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Secondary outcome [10]
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TTD on the EORTC QLQ-C30 Physical Functioning Scale
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Assessment method [10]
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The TTD on the EORTC QLQ-C30 physical functioning scale is defined as time from the date of randomization to the time a patient experienced at least 1 threshold value deterioration from baseline or death, whichever is earlier. Physical functioning scale is one of the five functional scales of the EORTC QLQ-
C30 questionnaire. After linear transformation, scale range in score from 0-100. A higher score on functional scales means better functioning and better quality of life.
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Timepoint [10]
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Randomization up to end of study (up to 5 years)
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Secondary outcome [11]
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [11]
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Timepoint [11]
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First dose date up to last dose date (up to 5 years) plus 70 days
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Secondary outcome [12]
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Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
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Assessment method [12]
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Timepoint [12]
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First dose date up to last dose date (up to 5 years) plus 70 days
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Secondary outcome [13]
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Serum Concentration of Magrolimab over time
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Assessment method [13]
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Timepoint [13]
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First dose date up to EOT (up to 5 years)
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Secondary outcome [14]
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Rate of Anti-Magrolimab Antibody Incidence
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Assessment method [14]
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Rate of anti-magrolimab antibody incidence is defined as the percentage of participants with anti-magrolimab antibodies.
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Timepoint [14]
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First dose date up to EOT (up to 5 years)
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Secondary outcome [15]
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Magnitude of Anti-Magrolimab Antibody Incidence
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Assessment method [15]
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Timepoint [15]
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First dose date up to EOT (up to 5 years)
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Eligibility
Key inclusion criteria
Key
* Previously untreated individuals with histological confirmation of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity. Individuals must be considered ineligible for intensive chemotherapy, defined by the following:
* = 75 years of age; Or
* = 18 to 74 years of age with at least 1 of the following comorbidities:
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3
* Diffusing capacity of the lung of carbon monoxide = 65% or forced expiratory volume in 1 second = 65%
* Left ventricular ejection fraction = 50%
* Baseline creatinine clearance = 30 mL/min to < 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection
* Hepatic disorder with total bilirubin > 1.5 x upper limit of normal (ULN)
* Any other comorbidity that the investigator judges to be incompatible with intensive chemotherapy
* ECOG performance status:
* Of 0 to 2 for individuals = 75 years of age Or
* Of 0 to 3 for individuals = 18 to 74 years of age
* Individuals with white blood cell (WBC) count = 20 x 10^3/µL prior to randomization. If the individual's WBC is > 20 x10^3/µL prior to randomization, the individual can be enrolled, assuming all other eligibility criteria are met. However, the WBC should be = 20 x 10^3/µL prior to the first dose of study treatment and prior to each magrolimab/placebo dose during Cycle 1.
* Note: Individuals can be treated with hydroxyurea and/or leukapheresis prior to randomization and throughout the study to reduce the WBC to = 20 x 10^3/µL to enable eligibility for study drug dosing
* Hemoglobin must be = 9 g/dL prior to initial dose of study treatment
* Note: Transfusions are allowed to meet hemoglobin eligibility
* Pretreatment blood cross-match completed
Key
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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
* Prior treatment with any of the following:
* cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPa)-targeting agents
* Antileukemic therapy for the treatment of AML (eg, hypomethylating agents (HMAs), low-dose cytarabine, and/or venetoclax), excluding hydroxyurea
* Note: Individuals with prior MDS who have not received prior HMAs or venetoclax or chemotherapeutic agents for MDS may be enrolled in the study. Prior treatment with myelodysplastic syndrome (MDS) therapies including, but not limited to lenalidomide, erythroid-stimulating agents, or similar red blood cell negative (RBC-), white blood cell negative (WBC-), or platelet-direct therapies or growth factors is allowed for these individuals.
* Clinical suspicion of or documented active central nervous system (CNS) involvement with AML
* Individuals who have acute promyelocytic leukemia
* Second malignancy, except MDS, treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anticancer therapies and have had no evidence of active malignancy for at least 1 year
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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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
7/07/2022
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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
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Actual
11/04/2024
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Sample size
Target
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Accrual to date
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Final
378
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
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Recruitment hospital [1]
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Canberra Hospital - Woden
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Recruitment hospital [2]
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Border Medical Oncology Research Unit - Albury
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Recruitment hospital [3]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [4]
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Liverpool Hospital - Liverpool
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Recruitment hospital [5]
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St George Hospital, Clinical Research Unit Haemotology, Division of Cancer Services - Sydney
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Recruitment hospital [6]
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Gold Coast University Hospital - Southport
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Recruitment hospital [7]
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Monash University, Eastern Health-Box Hill Hospital - Box Hill
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Recruitment hospital [8]
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Northern Health - Epping
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Recruitment hospital [9]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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2606 - Woden
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Recruitment postcode(s) [2]
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2640 - Albury
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Recruitment postcode(s) [3]
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2139 - Concord
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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2217 - Sydney
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Recruitment postcode(s) [6]
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4215 - Southport
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Recruitment postcode(s) [7]
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3128 - Box Hill
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Recruitment postcode(s) [8]
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3076 - Epping
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Recruitment postcode(s) [9]
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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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Arkansas
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California
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Florida
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Illinois
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Iowa
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Maryland
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Massachusetts
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Utah
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Austria
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Linz
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Gent
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Jihormoravsky KRAJ
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Olomouc
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Prague
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Amiens Cedex 1
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Bobigny
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La Tronche
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Nantes
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Vandoeuvre-les-Nancy
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Frankfurt
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Germany
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Hamburg
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Germany
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Hannover
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Magdeburg
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Germany
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Minden
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Muenchen
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Germany
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Oldenburg
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Germany
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Regensburg
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Germany
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Ulm
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Hong Kong
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Hungary
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Budapest
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Gyor
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Hungary
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Hajdu-bihar
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Hungary
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Szeged
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Italy
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Ancona
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Milano
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Italy
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Monza
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Italy
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Perugia
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Italy
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Pesaro
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Korea, Republic of
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Seoul
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Netherlands
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's-Hertogenbosch
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Netherlands
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Amersfoort
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Netherlands
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Amsterdam
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Netherlands
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Breda
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Netherlands
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Den Haag
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Netherlands
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Enschede
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Groningen
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Netherlands
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Leeuwarden
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Netherlands
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Maastricht
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Netherlands
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Nieuwegein
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Norway
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Oslo
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Poland
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Lublin
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Poland
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Opole
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Poland
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Lódz
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Spain
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Alava
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Salamanca
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Spain
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Santiago de Compostela
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Spain
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Valencia
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Switzerland
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Berne
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Taiwan
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Kaohsiung
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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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Blackpool
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United Kingdom
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Bristol
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United Kingdom
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Leeds
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United Kingdom
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Liverpool
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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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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Oxford
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United Kingdom
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Warwick
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.
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Trial website
https://clinicaltrials.gov/study/NCT05079230
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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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Gilead Study Director
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Address
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Gilead Sciences
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Contact person for public queries
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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/NCT05079230