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Clinical Trials in Taiwan / NCT03682536
Active, not recruiting Phase 3

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

NCT03682536 · tracked via the Priya Life Science Taiwan tracker
Sponsor
Celgene
Phase
Phase 3
Started
2019-01-02
Last updated
2024-11-20

Condition(s) studied

Myelodysplastic Syndromes

Investigational drug(s) / intervention(s)

Luspatercept →Epoetin alfa →

Luspatercept: Specified dose on specified days

Epoetin alfa: Specified dose on specified days

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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

Primary outcome measure(s)

  • 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 — Week 1 through Week 24
    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.

Trial sites (226)

FacilityCityRegionStatus
Local Institution - 107 Berkeley California
Local Institution - 115 San Diego California
Local Institution - 101 Whittier California
Local Institution - 104 New Haven Connecticut
Local Institution - 136 Washington D.C. District of Columbia
Local Institution - 119 Hudson Florida
Local Institution - 120 St. Petersburg Florida
Local Institution - 122 Tallahassee Florida
Local Institution - 108 Tampa Florida
Local Institution - 118 West Palm Beach Florida
Local Institution - 102 Paducah Kentucky
Local Institution - 123 Bethesda Maryland
Local Institution - 117 Kansas City Missouri
Local Institution - 134 East Brunswick New Jersey
Local Institution - 113 Hackensack New Jersey
Local Institution - 105 Greenville North Carolina
Local Institution - 131 Portland Oregon
Univ of Pittsburgh Medical Center Pittsburgh Pennsylvania
Local Institution - 111 Rock Hill South Carolina
Tennessee Oncology Nashville Tennessee
Baylor University Medical Center Dallas Texas
Local Institution - 109 Houston Texas
Local Institution - 114 Salt Lake City Utah
Local Institution - 132 Charlottesville Virginia
Local Institution - 127 Chesapeake Virginia
Local Institution - 206 Albury New South Wales
Local Institution - 213 Blacktown New South Wales
Local Institution - 200 Concord New South Wales
Local Institution - 215 Kogarah New South Wales
Local Institution - 211 Nowra New South Wales
Local Institution - 210 Waratah New South Wales
Local Institution - 207 Wollongong New South Wales
Local Institution - 208 Auchenflower Queensland
Local Institution - 202 Adelaide South Australia
Local Institution - 204 Clayton Victoria
Local Institution - 203 Malvern Victoria
Local Institution - 209 Melbourne Victoria
Local Institution - 205 West Perth Western Australia
Local Institution - 212 Randwick Australia
Local Institution - 442 Linz Austria

+ 186 more sites — see the full list on the official registry below.

More Celgene trials in Taiwan

A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer Active, not recruiting
A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials Recruiting
Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Active, not recruiting
Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma Active, not recruiting
Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma Active, not recruiting

Other trials for the same condition

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions Recruiting
A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1) Recruiting
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03682536 on ClinicalTrials.gov ↗ ← All trials in Taiwan