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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
20/11/2024

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
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) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions
Secondary ID [1] 0 0
U1111-1218-1810
Secondary ID [2] 0 0
ACE-536-MDS-002
Universal Trial Number (UTN)
Trial acronym
COMMANDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic Syndromes 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Anaemia
Blood 0 0 0 0
Other blood disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 1 through Week 24
Secondary outcome [1] 0 0
Percentage of Participants With Red Blood Cell Transfusion Independence (RBC-TI) for 24 Weeks
Timepoint [1] 0 0
Week 1 through Week 24
Secondary outcome [2] 0 0
Mean Hemoglobin Change Over 24 Weeks
Timepoint [2] 0 0
Week 1 through Week 24
Secondary outcome [3] 0 0
Percentage of Participants Achieving Hematologic Improvement - Erythroid Response (HI-E) Per IWG
Timepoint [3] 0 0
Week 1 through Week 24
Secondary outcome [4] 0 0
Time to Hematologic Improvement - Erythroid Response (HI-E)
Timepoint [4] 0 0
Week 1 through Week 24
Secondary outcome [5] 0 0
Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for = 12 Weeks (84 Days)
Timepoint [5] 0 0
Week 1 through Week 24
Secondary outcome [6] 0 0
Duration of Red Blood Cell Transfusion Independence (RBC-TI) = 12 Weeks (84 Days)
Timepoint [6] 0 0
Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks)
Secondary outcome [7] 0 0
Time to Red Blood Cell Transfusion Independence (RBC-TI) = 12 Weeks (84 Days)
Timepoint [7] 0 0
Week 1 through Week 24
Secondary outcome [8] 0 0
Time to First Red Blood Cell (RBC) Transfusion
Timepoint [8] 0 0
Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks)
Secondary outcome [9] 0 0
The Number of Red Blood Cell (RBC) Units Transfused Within the First 24 Weeks of Treatment
Timepoint [9] 0 0
Week 1 through Week 24
Secondary outcome [10] 0 0
Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for = 56 Days (8 Weeks)
Timepoint [10] 0 0
Week 1 through Week 24
Secondary outcome [11] 0 0
Percentage of Participants Achieving Red Blood Cell Transfusion Independence (RBC-TI) for a Consecutive 24-week Period
Timepoint [11] 0 0
Week 1 through Week 48
Secondary outcome [12] 0 0
The Number of Participants With Acute Myeloid Leukemia (AML) Progression
Timepoint [12] 0 0
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)
Secondary outcome [13] 0 0
Median Time to Acute Myeloid Leukemia (AML) Progression
Timepoint [13] 0 0
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)
Secondary outcome [14] 0 0
Overall Survival (OS)
Timepoint [14] 0 0
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)
Secondary outcome [15] 0 0
The Number of Participants With Adverse Events (AEs)
Timepoint [15] 0 0
From first dose to 42 days post last dose (Up to approximately an average of 72 weeks and a maximum of 208 weeks)
Secondary outcome [16] 0 0
Number of Participants With a Positive Anti-drug Antibody (ADA) Test
Timepoint [16] 0 0
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
Secondary outcome [17] 0 0
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30)
Timepoint [17] 0 0
Baseline and week 24.
Secondary outcome [18] 0 0
Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An)
Timepoint [18] 0 0
Baseline, Day 1 on weeks 7,13,19, and 24.
Secondary outcome [19] 0 0
Area Under the Concentration-time Curve [AUC]
Timepoint [19] 0 0
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
Secondary outcome [20] 0 0
Maximum Plasma Concentration of Drug [Cmax]
Timepoint [20] 0 0
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

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/09/2027
Actual
Sample size
Target
Accrual to date
Final
363
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 206 - Albury
Recruitment hospital [2] 0 0
Local Institution - 213 - Blacktown
Recruitment hospital [3] 0 0
Local Institution - 200 - Concord
Recruitment hospital [4] 0 0
Local Institution - 215 - Kogarah
Recruitment hospital [5] 0 0
Local Institution - 211 - Nowra
Recruitment hospital [6] 0 0
Local Institution - 210 - Waratah
Recruitment hospital [7] 0 0
Local Institution - 207 - Wollongong
Recruitment hospital [8] 0 0
Local Institution - 208 - Auchenflower
Recruitment hospital [9] 0 0
Local Institution - 202 - Adelaide
Recruitment hospital [10] 0 0
Local Institution - 204 - Clayton
Recruitment hospital [11] 0 0
Local Institution - 203 - Malvern
Recruitment hospital [12] 0 0
Local Institution - 209 - Melbourne
Recruitment hospital [13] 0 0
Local Institution - 205 - West Perth
Recruitment hospital [14] 0 0
Local Institution - 212 - Randwick
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2541 - Nowra
Recruitment postcode(s) [6] 0 0
2298 - Waratah
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment postcode(s) [8] 0 0
4066 - Auchenflower
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
3168 - Clayton
Recruitment postcode(s) [11] 0 0
3144 - Malvern
Recruitment postcode(s) [12] 0 0
3004 - Melbourne
Recruitment postcode(s) [13] 0 0
6005 - West Perth
Recruitment postcode(s) [14] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Connecticut
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Utah
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Linz
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Vienna
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TO
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Bologna
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Osaka
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Braga
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Winterthur
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Country [179] 0 0
United Kingdom
State/province [179] 0 0
Headington, Oxford
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Lincoln
Country [181] 0 0
United Kingdom
State/province [181] 0 0
London
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03682536