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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03682536




Registration number
NCT03682536
Ethics application status
Date submitted
7/09/2018
Date registered
24/09/2018
Date last updated
1/12/2023

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) ESA in Native 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
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
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
Hematologic improvement - erythroid response (HI-E) per International Working Group (IWG)
Timepoint [3] 0 0
Week 1 through Week 24
Secondary outcome [4] 0 0
Time to HI-E
Timepoint [4] 0 0
Week 1 through Week 24
Secondary outcome [5] 0 0
RBC-TI for = 12 weeks (84 days)
Timepoint [5] 0 0
Week 1 through Week 24
Secondary outcome [6] 0 0
Duration of RBC-TI = 12 weeks (84 days)
Timepoint [6] 0 0
Week 1 through End of Treatment (EOT), up to approximately 60 months
Secondary outcome [7] 0 0
Time to 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 EOT, up to approximately 60 months
Secondary outcome [9] 0 0
RBC transfusion burden on treatment
Timepoint [9] 0 0
Week 1 through Week 24
Secondary outcome [10] 0 0
RBC-TI for = 56 days (8 weeks)
Timepoint [10] 0 0
Week 1 through Week 24
Secondary outcome [11] 0 0
RBC-TI for a consecutive 24-week period
Timepoint [11] 0 0
Week 1 through Week 48
Secondary outcome [12] 0 0
The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30)
Timepoint [12] 0 0
Screening through Week 24
Secondary outcome [13] 0 0
The Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An) questionnaire
Timepoint [13] 0 0
Screening through Week 24
Secondary outcome [14] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [14] 0 0
Week 1 through 42 days post last dose
Secondary outcome [15] 0 0
Pharmacokinetic - area under the concentration-time curve (AUC)
Timepoint [15] 0 0
Randomization through 1-year post first dose
Secondary outcome [16] 0 0
Pharmacokinetic - maximum plasma concentration of drug (Cmax)
Timepoint [16] 0 0
Randomization through 1-year post first dose
Secondary outcome [17] 0 0
Frequency of antidrug antibodies (ADA)
Timepoint [17] 0 0
Randomization through 1-year post first dose
Secondary outcome [18] 0 0
Number of participants progressing to acute myeloid leukemia (AML)
Timepoint [18] 0 0
Randomization through up to 60 months
Secondary outcome [19] 0 0
Percentage of participants progressing to AML
Timepoint [19] 0 0
Randomization through up to 60 months
Secondary outcome [20] 0 0
Time to AML progression
Timepoint [20] 0 0
Randomization through up to 60 months
Secondary outcome [21] 0 0
Overall survival
Timepoint [21] 0 0
Randomization through up to 60 months

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
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2148 - Blacktown
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2139 - Concord
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2217 - Kogarah
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2541 - Nowra
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2298 - Waratah
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2500 - Wollongong
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4066 - Auchenflower
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5000 - Adelaide
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3168 - Clayton
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3144 - Malvern
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3004 - Melbourne
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6005 - West Perth
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2031 - Randwick
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Kyiv
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Lvov
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Ternopil
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Aberdeen
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Bournemouth
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Headington, Oxford
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London
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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
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03682536
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03682536