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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03682536
Registration number
NCT03682536
Ethics application status
Date submitted
7/09/2018
Date registered
24/09/2018
Date last updated
26/06/2024
Titles & IDs
Public title
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
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Scientific title
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions
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Secondary ID [1]
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U1111-1218-1810
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Secondary ID [2]
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ACE-536-MDS-002
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Universal Trial Number (UTN)
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Trial acronym
COMMANDS
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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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Anaemia
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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 - Luspatercept
Treatment: Drugs - Epoetin alfa
Experimental: Luspatercept -
Active comparator: Epoetin alfa -
Treatment: Drugs: Luspatercept
Specified dose on specified days
Treatment: Drugs: Epoetin alfa
Specified dose on specified days
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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 Red Blood Cell Transfusion Independence (RBC-TI) for 12 Weeks (84 Days) With a Mean Hemoglobin Increase = 1.5 g/dL
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Assessment method [1]
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Percentage of participants who are RBC transfusion-free for any 12-week period associated with a concurrent mean hemoglobin (Hgb) increase = 1.5 g/dL compared to baseline.
After applying below 14/3-day rule, the baseline Hgb value is defined as the lowest Hgb value from the central, local laboratory, or pre transfusion Hgb from transfusion records that is within 56 days on or prior to the first dose of treatment, or randomization date if participants were not treated.
4/3-day rule: only Hgb values that are at least 14 days after a transfusion may be used unless there is another transfusion within 3 days after the Hgb assessment. If this occurs, that Hgb value will be used despite being \< 14 days after the previous transfusion.
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Timepoint [1]
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Week 1 through Week 24
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Secondary outcome [1]
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Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 24 Weeks
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Assessment method [1]
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Red blood cell transfusion independence (RBC-TI) for 24 weeks is defined as the percentage of participants who did not receive RBC transfusions from Week 1 through Week 24.
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Timepoint [1]
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Week 1 through Week 24
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Secondary outcome [2]
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Mean Hemoglobin Change Over 24 Weeks
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Assessment method [2]
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Mean hemoglobin (Hgb) change over the 24-week period of Week 1 through Week 24 compared to baseline.
After applying below 14/3-day rule, the baseline Hgb value is defined as the lowest Hgb value from the central, local laboratory, or pre transfusion Hgb from transfusion records that is within 56 days on or prior to the first dose of treatment, or randomization date if participants were not treated.
4/3-day rule: only Hgb values that are at least 14 days after a transfusion may be used unless there is another transfusion within 3 days after the Hgb assessment. If this occurs, that Hgb value will be used despite being \< 14 days after the previous transfusion.
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Timepoint [2]
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Week 1 through Week 24
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Secondary outcome [3]
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Percentage of Participants Achieving Hematologic Improvement - Erythroid Response (HI-E) Per IWG
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Assessment method [3]
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The percentage of participants meeting the modified HI-E criteria per the International Working Group (IWG) sustained over any consecutive 56-day period in Week 1-24: For participants with baseline red blood cell (RBC) transfusion burden of \>= 4 units/8 weeks, a reduction of at least 4 units RBC transfusion; for participants with baseline RBC transfusion burden of \< 4 units/8 weeks, mean increase of hemoglobin of at least 1.5 g/dL in the absence of transfusions.
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Timepoint [3]
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Week 1 through Week 24
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Secondary outcome [4]
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Time to Hematologic Improvement - Erythroid Response (HI-E)
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Assessment method [4]
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Time from first dose to first onset of achieving modified HI-E.
The modified HI-E criteria per the International Working Group (IWG) sustained over any consecutive 56-day period in Week 1-24: For participants with baseline red blood cell (RBC) transfusion burden of \>= 4 units/8 weeks, a reduction of at least 4 units RBC transfusion; for participants with baseline RBC transfusion burden of \< 4 units/8 weeks, mean increase of hemoglobin of at least 1.5 g/dL in the absence of transfusions.
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Timepoint [4]
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Week 1 through Week 24
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Secondary outcome [5]
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Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for = 12 Weeks (84 Days)
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Assessment method [5]
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Percentage of participants who are RBC transfusion-free over a consecutive 84-day period.
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Timepoint [5]
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Week 1 through Week 24
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Secondary outcome [6]
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Duration of Red Blood Cell Transfusion Independence (RBC-TI) = 12 Weeks (84 Days)
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Assessment method [6]
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Maximum duration of RBC transfusion independence for participants who achieve RBC-TI = 84 days.
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Timepoint [6]
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Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks)
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Secondary outcome [7]
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Time to Red Blood Cell Transfusion Independence (RBC-TI) = 12 Weeks (84 Days)
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Assessment method [7]
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Time from first dose to first onset of transfusion independence = 84 days.
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Timepoint [7]
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Week 1 through Week 24
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Secondary outcome [8]
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Time to First Red Blood Cell (RBC) Transfusion
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Assessment method [8]
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Time to first RBC transfusion is defined as time from Week 1 to first RBC transfusion on treatment. Participants who maintain RBC-TI through the end of the Treatment Period or time of analysis will be censored at EOT visit date, subsequent MDS therapy start date, study discontinuation date, analysis cutoff date or death, whichever occurs first. Median is from un-stratified Kaplan-Meier method.
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Timepoint [8]
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Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks)
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Secondary outcome [9]
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The Number of Red Blood Cell (RBC) Units Transfused Within the First 24 Weeks of Treatment
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Assessment method [9]
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RBC transfusion burden on treatment is defined as total number of packed red blood cell (pRBC) units transfused within the first 24 weeks of treatment since Week 1.
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Timepoint [9]
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Week 1 through Week 24
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Secondary outcome [10]
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Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for = 56 Days (8 Weeks)
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Assessment method [10]
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Defined as percentage of participants achieving RBC-TI for \>= 56 days during any consecutive 56-day period from Week 1 through Week 24.
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Timepoint [10]
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Week 1 through Week 24
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Secondary outcome [11]
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Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for a Consecutive 24-week Period
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Assessment method [11]
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Defined as percentage of participants achieving RBC-TI for \>= 168 days during any consecutive 168-day period from Week 1 through Week 48.
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Timepoint [11]
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Week 1 through Week 48
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Secondary outcome [12]
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The Number of Participants With Acute Myeloid Leukemia (AML) Progression
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Assessment method [12]
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Progression to AML is defined as a diagnosis of AML as per WHO classification of = 20% blasts in peripheral blood or bone marrow.
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Timepoint [12]
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From randomization to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks)
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Secondary outcome [13]
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Median Time to Acute Myeloid Leukemia (AML) Progression
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Assessment method [13]
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Time to AML progression is defined as the time between randomization and first diagnosis of AML as per WHO classification of = 20% blasts in peripheral blood or bone marrow. Participants with diagnosis of AML will be considered to have had an event. Participants who have not progressed to AML at the time of analysis will be censored at the last assessment date which does not indicate progression to AML estimated by Kaplan-Meier method.
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Timepoint [13]
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From randomization to first diagnosis of AML up to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks)
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Secondary outcome [14]
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Overall Survival (OS)
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Assessment method [14]
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Time from date of randomization to death due to any cause
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Timepoint [14]
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Randomization to death due to any cause up to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks)
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Secondary outcome [15]
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The Number of Participants With Adverse Events (AEs)
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Assessment method [15]
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Treatment-emergent adverse events include adverse events that started on or after the first dose of treatment until 42 days after the last dose of treatment, as well as those serious adverse events (SAEs) made known to the investigator at any time thereafter that are suspected of being related to treatment.
The severity/intensity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0). Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.
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Timepoint [15]
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From first dose to 42 days post last dose (Up to approximately an average of 72 weeks and a maximum of 208 weeks)
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Secondary outcome [16]
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Number of Participants With a Positive Anti-drug Antibody (ADA) Test
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Assessment method [16]
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Number of participants under each ADA positive category. A participant is counted as 'Treatment-Emergent' if there is a positive post-baseline sample while the baseline sample is ADA negative, or there is a positive post-baseline sample with a titer \>= 4-fold of the baseline titer while the baseline sample is ADA positive. A participant is counted as 'Preexisting' if the baseline sample is ADA positive and the participant is not qualified for 'Treatment-Emergent'. If the participant was discontinued from study treatment earlier than one year from the first dose, additional samples will be collected if last ADA is positive.
Baseline is defined as the last value on or before the first dose of study drug.
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Timepoint [16]
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Day 1 on week 4, 10, 16, 22, and every 12 weeks (±14 days) from the 24-Week MDS Assessment visit for up to one year from the first dose
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Secondary outcome [17]
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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30)
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Assessment method [17]
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The EORTC QLQ-C30 is composed of 30 items that includes a global health status score ranging from: 1-7 as well as scores for 5 functional scales (physical, role, emotional, cognitive and social), 3 symptom scales (fatigue, nausea/vomiting, and pain) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) all ranging from 1-4. Subscale scores are transformed to a 0 to 100 scale. A high score for a functional scale represents a high or healthy level of functioning; a high score for the global health status/health related quality of life (HRQoL) represents a high overall HRQoL; but a high score for a symptom scale represents a high level of symptomatology or problems. Baseline is defined as the last value on or before the first dose of study drug.
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Timepoint [17]
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Baseline and week 24.
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Secondary outcome [18]
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Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An)
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Assessment method [18]
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The Functional Assessment of Cancer Therapy - Anemia (FACT-An) questionnaire includes 47 items rating on a 5-point Likert scale from 0 (not at all) to 4 (very much) (so that 0 is considered worse quality of life and 4 is good response) on five primary subscales:
* Physical well-being (sum of 7 items, score range from 0-28)
* Social/Family well-being (sum of 7 items, score range from 0-28)
* Emotional well-being (sum of 6 items, score range from 0-24)
* Functional well-being (sum of 7 items, score range from 0-28)
* Anemia-related symptoms (sum of 20 items, score range from 0-80)
A total score for the FACT-An can be calculated by summing the five primary subscales with a score range from 0-188. Higher scores representing better quality of life. Baseline is defined as the last value on or before the first dose of study drug.
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Timepoint [18]
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Baseline, Day 1 on weeks 7,13,19, and 24.
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Secondary outcome [19]
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Area Under the Concentration-time Curve [AUC]
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Assessment method [19]
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0
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Timepoint [19]
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Day 1 on week 4, 10, 16, 22, and every 12 weeks (±14 days) from the 24-Week MDS Assessment visit for up to one year from the first dose
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Secondary outcome [20]
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Maximum Plasma Concentration of Drug [Cmax]
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Assessment method [20]
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0
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Timepoint [20]
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Day 1 on week 4, 10, 16, 22, and every 12 weeks (±14 days) from the 24-Week MDS Assessment visit for up to one year from the first dose
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Eligibility
Key inclusion criteria
* Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have < 5% blasts in bone marrow
* Endogenous serum erythropoietin (sEPO) level of < 500 U/L
* Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization
* Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
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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
* Clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia
* Known history of diagnosis of Acute myeloid leukemia (AML)
* Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of = 150 mmHg and/or diastolic blood pressure (DBP) = 100 mmHg despite adequate treatment
Other protocol-defined inclusion/exclusion criteria 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
Open (masking not used)
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Who is / are masked / blinded?
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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
Active, not 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
2/01/2019
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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
28/09/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
363
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 206 - Albury
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Recruitment hospital [2]
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0
Local Institution - 213 - Blacktown
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Recruitment hospital [3]
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0
Local Institution - 200 - Concord
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Recruitment hospital [4]
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0
Local Institution - 215 - Kogarah
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Recruitment hospital [5]
0
0
Local Institution - 211 - Nowra
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Recruitment hospital [6]
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0
Local Institution - 210 - Waratah
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Recruitment hospital [7]
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0
Local Institution - 207 - Wollongong
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Recruitment hospital [8]
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0
Local Institution - 208 - Auchenflower
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Recruitment hospital [9]
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0
Local Institution - 202 - Adelaide
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Recruitment hospital [10]
0
0
Local Institution - 204 - Clayton
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Recruitment hospital [11]
0
0
Local Institution - 203 - Malvern
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Recruitment hospital [12]
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0
Local Institution - 209 - Melbourne
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Recruitment hospital [13]
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0
Local Institution - 205 - West Perth
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Recruitment hospital [14]
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0
Local Institution - 212 - Randwick
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Recruitment postcode(s) [1]
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0
2640 - Albury
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Recruitment postcode(s) [2]
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2148 - Blacktown
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Recruitment postcode(s) [3]
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0
2139 - Concord
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Recruitment postcode(s) [4]
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2217 - Kogarah
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Recruitment postcode(s) [5]
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2541 - Nowra
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Recruitment postcode(s) [6]
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2298 - Waratah
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Recruitment postcode(s) [7]
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2500 - Wollongong
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Recruitment postcode(s) [8]
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4066 - Auchenflower
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Recruitment postcode(s) [9]
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5000 - Adelaide
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Recruitment postcode(s) [10]
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3168 - Clayton
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Recruitment postcode(s) [11]
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0
3144 - Malvern
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Recruitment postcode(s) [12]
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0
3004 - Melbourne
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Recruitment postcode(s) [13]
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0
6005 - West Perth
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Recruitment postcode(s) [14]
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2031 - Randwick
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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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California
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0
United States of America
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State/province [2]
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0
Connecticut
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0
0
United States of America
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State/province [3]
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0
District of Columbia
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0
United States of America
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State/province [4]
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Florida
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0
0
United States of America
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State/province [5]
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Kentucky
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0
0
United States of America
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State/province [6]
0
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Maryland
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0
0
United States of America
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Missouri
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0
0
United States of America
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State/province [8]
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0
New Jersey
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0
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United States of America
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North Carolina
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0
0
United States of America
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0
Oregon
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0
0
United States of America
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State/province [11]
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Pennsylvania
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0
0
United States of America
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State/province [12]
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South Carolina
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0
United States of America
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State/province [13]
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Tennessee
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0
0
United States of America
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State/province [14]
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0
Texas
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0
United States of America
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State/province [15]
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Utah
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Country [16]
0
0
United States of America
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State/province [16]
0
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Virginia
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Country [17]
0
0
Austria
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State/province [17]
0
0
Linz
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Country [18]
0
0
Austria
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State/province [18]
0
0
Vienna
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Country [19]
0
0
Belgium
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State/province [19]
0
0
Antwerpen
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Country [20]
0
0
Belgium
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State/province [20]
0
0
Brasschaat
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Country [21]
0
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Belgium
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State/province [21]
0
0
Brussels
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Country [22]
0
0
Belgium
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State/province [22]
0
0
Charleroi
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0
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Belgium
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State/province [23]
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Kortrijk
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Country [24]
0
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Belgium
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State/province [24]
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Leuven
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0
0
Belgium
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State/province [25]
0
0
Roeselare
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Country [26]
0
0
Canada
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State/province [26]
0
0
Alberta
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Country [27]
0
0
Canada
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State/province [27]
0
0
Ontario
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Country [28]
0
0
Canada
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State/province [28]
0
0
Quebec
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Country [29]
0
0
Canada
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State/province [29]
0
0
Saskatchewan
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Country [30]
0
0
Canada
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State/province [30]
0
0
Sherbrooke
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Country [31]
0
0
Czechia
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State/province [31]
0
0
Hradec Kralove
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0
0
Czechia
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State/province [32]
0
0
Ostrava-Poruba
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0
0
Czechia
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State/province [33]
0
0
Prague 10
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0
0
Czechia
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State/province [34]
0
0
Praha 2
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0
0
Czechia
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0
0
Praha
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0
0
France
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State/province [36]
0
0
Angers
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0
0
France
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0
0
Bayonne
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0
0
France
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State/province [38]
0
0
Caen Cedex 9
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Country [39]
0
0
France
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State/province [39]
0
0
La Tronche
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Country [40]
0
0
France
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State/province [40]
0
0
Le Mans
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0
0
France
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State/province [41]
0
0
Lille
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0
0
France
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State/province [42]
0
0
Limoges Cedex
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Country [43]
0
0
France
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State/province [43]
0
0
Nantes Cedex 01
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Country [44]
0
0
France
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State/province [44]
0
0
Nice Cedex 3
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Country [45]
0
0
France
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State/province [45]
0
0
Paris
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Country [46]
0
0
France
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State/province [46]
0
0
Pessac
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Country [47]
0
0
France
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State/province [47]
0
0
Pierre Bénite
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Country [48]
0
0
France
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State/province [48]
0
0
Poitiers
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Country [49]
0
0
France
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State/province [49]
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Israel
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TO
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Kyiv
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Ternopil
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United Kingdom
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Aberdeen
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Headington, Oxford
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United Kingdom
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Lincoln
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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
Celgene
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
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0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).
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Trial website
https://clinicaltrials.gov/study/NCT03682536
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Public notes
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Contacts
Principal investigator
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0
0
Bristol-Myers Squibb
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Bristol-Myers Squibb
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/36/NCT03682536/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/36/NCT03682536/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03682536
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