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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04313881
Registration number
NCT04313881
Ethics application status
Date submitted
11/03/2020
Date registered
18/03/2020
Titles & IDs
Public title
Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
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Scientific title
ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome
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Secondary ID [1]
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2020-004287-26
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Secondary ID [2]
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5F9009
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Universal Trial Number (UTN)
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Trial acronym
ENHANCE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic Syndromes
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Condition category
Condition code
Blood
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Haematological diseases
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Blood
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Other blood disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Magrolimab
Treatment: Drugs - Azacitidine
Treatment: Drugs - Placebo
Experimental: Magrolimab + Azacitidine - Participants will receive the following magrolimab and azacitidine dosing regimens:
Magrolimab:
Magrolimab Priming Dose:
* 1 mg/kg on Days 1 and 4
* 15 mg/kg on Day 8
* 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50)
Magrolimab Maintenance Dose:
* 30 mg/kg on Day 57 and 30 mg/kg every 2 weeks thereafter.
Azacitidine: 75 mg/m\^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle.
Placebo comparator: Control Arm (Placebo + Azacitidine) - Participants will receive the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine:
Placebo: On Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter.
Azacitidine: 75 mg/m\^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each cycle.
Treatment: Drugs: Magrolimab
Administered intravenously
Treatment: Drugs: Azacitidine
Administered either subcutaneously (SC) or intravenously (IV) according to region-specific drug labeling
Treatment: Drugs: Placebo
Placebo to match magrolimab administered intravenously
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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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Percentage of Participants With Complete Remission (CR)
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Assessment method [1]
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The percentage of participants (CR rate) are participants who reach morphologic CR (morphological blast of = 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast) based on Investigator-assessed International Working Group (IWG) myelodysplastic syndrome (MDS) criteria on or prior to initiation of any new anticancer therapy, including stem cell therapy (SCT). Percentages were rounded off.
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Timepoint [1]
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From randomization up to 31.01 months
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the number of months measured from the date of randomization to the date of death from any cause. Kaplan Meier (KM) estimates were used for analysis.
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Timepoint [2]
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From randomization up to 32.62 months
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Secondary outcome [1]
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Duration of CR (DOCR)
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Assessment method [1]
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DOCR=Time from first CR date to the first date of relapse, disease progression (PD) or death, prior to initiation of any new anticancer therapy excluding SCT whichever occurs earlier. PD is defined as: \<5% blasts: =50 increase in blasts to \>5% blasts,5%-10% blasts: =50% increase in blasts to \>10% blasts, 10%-20% blasts: =50% increase in blasts to \>20% blasts,20%-30% blasts: =50% increase in blasts to \>30% blasts, any of the following: at least 50% decrement from maximum remission/response in granulocytes or platelets. Reduction in Hgb by =2 g/dL / Transfusion dependence. Relapse is defined as return to pretreatment bone marrow blast percentage / decrement of = 50% from maximum remission/response levels in granulocytes or platelets/ reduction in Hgb concentration by = 1.5 g/dL or transfusion dependence. CR is defined in outcome measure 1. KM estimates were used for analysis.
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Timepoint [1]
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From randomization up to 31.01 months
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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ORR is defined as the percentage of participants who reach objective response including CR, partial remission (PR), marrow CR or hematological improvement prior to initiation of any new anticancer therapy including SCT for MDS per IWG 2006 criteria per investigator's evaluation. CR is defined in outcome measure 1.
PR is defined as all CR criteria if abnormal before treatment except, one marrow blasts decreased by = 50% over pretreatment but still \> 5% cellularity and morphology not relevant.
Marrow CR is defined as bone marrow = 5% myeloblasts and decrease by = 50% over pretreatment, stable disease with any hematological improvement, peripheral blood: if hematological improvement responses, they were noted in addition to marrow CR.
Stable Disease: Failure to achieve at least PR, but no evidence of progression for \> 8 weeks.
Percentages were rounded off.
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Timepoint [2]
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From randomization up to 31.01 months
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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DOR is measured from time measurement criteria are first met for objective response to first date of relapse, disease progression (PD) /death, prior to initiation of any new anticancer therapy excluding SCT whichever occurs earlier.
Disease progression and relapse have been defined in outcome measure number 3. KM estimates were used for analysis.
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Timepoint [3]
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From randomization up to 31.01 months
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Secondary outcome [4]
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Red Blood Cell (RBC) Transfusion Independence Rate
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Assessment method [4]
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RBC transfusion independence rate is defined as the percentage of participants who have a 56-day or longer period with no RBC transfusions at any time between randomization and initiation of any new anticancer therapy, including SCT, among all participants who were RBC transfusion-dependent at Baseline. Percentages were rounded off.
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Timepoint [4]
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From randomization up to 31.01 months
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Secondary outcome [5]
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Event Free Survival (EFS)
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Assessment method [5]
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EFS is defined as the time from randomization to transformation to acute myeloid leukemia (AML) or death from any cause, whichever occurs first.
Transformation assessments and deaths post SCT were included in the analysis. KM estimates were used for analysis
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Timepoint [5]
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From randomization up to 31.01 months
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Secondary outcome [6]
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Percentage of Participants With CR in Participants With TP53 Mutation
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Assessment method [6]
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CR in TP53 mutant population is defined as the percentage of participants who achieve a morphologic CR based on investigator assessments using IWG criteria on or prior to initiation of any new anticancer therapy, including SCT in TP53 mutant population. Percentages were rounded off.
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Timepoint [6]
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From randomization up to 31.01 months
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Secondary outcome [7]
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Minimal Residual Disease (MRD)-Negative Response Rate
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Assessment method [7]
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The MRD-negative response rate is defined as the percentage of participants who achieved a morphologic CR or marrow CR based on Investigator-assessed IWG criteria and reached MRD-negative disease status prior to initiation of any new anticancer therapy, including SCT. MRD-negative disease status was assessed using a multiparameter flow cytometry-based assay performed by a central laboratory.
Morphologic CR and marrow CR are defined in outcome measures 1 and 4, respectively.
Percentages were rounded off.
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Timepoint [7]
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From randomization up to 31.01 months
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Secondary outcome [8]
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Time to Transformation to AML
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Assessment method [8]
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Time to transformation to AML is defined as the time from randomization to the collection date of bone marrow sample leading to documented AML diagnosis. Transformation assessments post SCT were included in the analysis.KM estimates were used for analysis.
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Timepoint [8]
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From randomization up to 31.01 months
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Secondary outcome [9]
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Progression Free Survival (PFS)
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Assessment method [9]
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PFS is defined as the time from randomization to the date of documented DP (including treatment failure by IWG criteria or relapse after PR/CR), or death from any cause, whichever occurs first. Response assessments and deaths post SCT were included in the analysis. Treatment failure is defined as, Death during treatment or disease progression characterized by worsening cytopenia, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment. Relapse after CR or PR = Return to pretreatment bone marrow blast percentage / Decrement of = 50% from maximum remission/response levels in granulocytes or platelets / Reduction in Hgb concentration by = 1.5 g/dL or transfusion dependence.
CR, PR and PD are defined in outcome measures 1, 4 and 5 respectively. KM estimates were used for analysis.
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Timepoint [9]
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From randomization up to 31.01 months
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Secondary outcome [10]
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Functional Assessment of Cancer Therapy-Anemia (FACT-Anemia) Response Rate
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Assessment method [10]
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The FACT-Anemia response rate is defined as the percentage of participants who showed clinically meaningful improvement in health-related quality of life (HRQoL) based on the score from the FACT-Anemia instrument prior to initiation of any new anticancer therapy, including SCT. The minimal clinically meaningful difference of 7.0 was used as cutoff for clinically meaningful improvement.
The FACT-Anemia instrument consists of 5 subscales, including physical well-being, emotional well-being, functional well-being, social well-being, and anemia symptoms. Each subscale measures items on a 5-point Likert scale from 0 to 4, where 0 = not at all and 4 = very much. The subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 indicates the poorest quality of life (QOL) and 100 denotes the highest QOL.
Percentages were rounded off.
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Timepoint [10]
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Up to week 136
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Secondary outcome [11]
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
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Assessment method [11]
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TEAE's are defined as any AEs with an onset date on or after the study drug start date, no later than 70 days after study drug last dose date or day before initiation of new anticancer therapy including SCT. If AE onset date is on or before last dose date, it is considered as TEAE regardless of start of new anticancer therapy. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product or other protocol imposed intervention, regardless of attribution. An event is considered "serious", if it results death, life-threatening, inpatient or prolongation hospitalization, incapacity or substantial disruption of the ability to conduct normal functions, a congenital anomaly/birth defect, and important medical events.
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Timepoint [11]
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First dose date up to 135.9 weeks plus 70 days (Up to 2.8 years)
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Secondary outcome [12]
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Serum Concentration of Magrolimab
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Assessment method [12]
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Pretreatment assessments for the initial dose may be collected up to 72 hours before administration of study treatment; thereafter, pretreatment assessments are to be collected within 24 hours prior to study treatment administration.
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Timepoint [12]
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Preinfusion on Days 0, 7, 28, 56, 112, 168, 252 and 336
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Secondary outcome [13]
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Percentage of Participants With Positive Anti-magrolimab Antibodies
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Assessment method [13]
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Percentages were rounded off.
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Timepoint [13]
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Up to 72 hours before administration of any treatment at Day 1, Cycle 1; within 24 hours prior to any study drug administration at Day 1 of Cycles 2, 3, 5, 7, 10, and 13 and End of Treatment (± 7 Days after last study drug dose); Cycle length is 28 Days
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Eligibility
Key inclusion criteria
Key
* Participants with Myelodysplastic Syndrome (MDS) defined according to World Health Organization classification, with Revised International Prognostic Scoring System (IPSS-R) prognostic risk category of intermediate, high, or very high risk.
* Adequate performance status and hematological, liver, and kidney function.
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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
* Immediate eligibility for allogenic stem cell transplant (SCT), as determined by the investigator, with an available donor.
* Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPa)-targeting agents.
* Any prior antileukemic therapy for treatment of intermediate, high, very high risk MDS per IPSS-R.
* Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which participants are not on active anticancer therapies and have had no evidence of active malignancy for at least = 1 year.
* Contraindications to azacitidine.
* Clinical suspicion of active central nervous system (CNS) involvement by MDS.
* Known active or chronic hepatitis B or C infection or human immunodeficiency virus in medical history .
* Active hepatitis B virus and/or active hepatitis C virus, and/or HIV following testing at screening.
* Pregnancy or active breastfeeding.
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
9/09/2020
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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
13/09/2023
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Sample size
Target
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Accrual to date
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Final
539
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Gosford Hospital - Gosford
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Prince of Wales Hospital - Randwick
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Royal North Shore Hospital - St Leonards
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Westmead Hospital - Westmead
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Icon Cancer Foundation - South Brisbane
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Royal Adelaide Hospital - Adelaide
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Flinders Medical Center - Bedford Park
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Royal Hobart Hospital - Hobart
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Recruitment hospital [9]
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Eastern Health - Box Hill
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Monash Medical Centre - Clayton
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Peninsula Private Hospital - Frankston
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Barwon Health, University Hospital Geelong - Geelong
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Cabrini Hospital Malvern - Malvern
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The Alfred Hospital - Melbourne
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Royal Melbourne Hospital - Parkville
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2250 - Gosford
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2031 - Randwick
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2065 - St Leonards
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2145 - Westmead
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4101 - South Brisbane
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5000 - Adelaide
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5042 - Bedford Park
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7000 - Hobart
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3128 - Box Hill
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3168 - Clayton
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3199 - Frankston
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3220 - Geelong
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Recruitment postcode(s) [13]
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3144 - Malvern
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Recruitment postcode(s) [14]
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3004 - Melbourne
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3050 - Parkville
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Recruitment postcode(s) [16]
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6009 - Nedlands
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Recruitment outside Australia
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Pierre Benite
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Novara
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Italy
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Italy
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Terni
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Italy
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Bergen
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Stavanger
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Braga
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Porto
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A Coruña
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Alava
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Girona
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L´Hospitalet de Llobregat
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Madrid
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Pamplona
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Valencia
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Bellinzona
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Bern
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Zurich
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Inciralt
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Mersin
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Tekirdag
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United Kingdom
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Birmingham
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Boston
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Canterbury
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United Kingdom
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Oxford
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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 primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).
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Trial website
https://clinicaltrials.gov/study/NCT04313881
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Public notes
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Contacts
Principal investigator
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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 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
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/81/NCT04313881/Prot_000.pdf
Statistical analysis plan
Statistical Analysis Plan: First Interim Analyses
https://cdn.clinicaltrials.gov/large-docs/81/NCT04313881/SAP_001.pdf
Statistical analysis plan
Statistical Analysis Plan: Second Interim and Fina...
[
More Details
]
https://cdn.clinicaltrials.gov/large-docs/81/NCT04313881/SAP_002.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04313881