Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03682536 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Myelodysplastic Syndromes, sponsored by Celgene.
- Active
- Registry status
- Phase 3
- Development phase
- 363
- Enrollment target
- 20
- Study locations
NCT03682536 is a Phase 3 study of Myelodysplastic Syndromes that is active but no longer recruiting, run by Celgene. The registered enrollment target is 363 participants, above the 283-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT03682536, a Phase 3 study of Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by Celgene.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 363 participants
- Enrollment target
- 20
- Study locations
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).
Conditions Studied
Interventions
- DRUG Luspatercept
- DRUG Epoetin alfa
Study Locations (20)
Florida
- Local Institution - 119 - Hudson
- Local Institution - 120 - St. Petersburg
- Local Institution - 122 - Tallahassee
- Local Institution - 108 - Tampa
- Local Institution - 118 - West Palm Beach
California
- Local Institution - 107 - Berkeley
- Local Institution - 115 - San Diego
- Local Institution - 101 - Whittier
New Jersey
- Local Institution - 134 - East Brunswick
- Local Institution - 113 - Hackensack
Connecticut
- Local Institution - 104 - New Haven
District of Columbia
- Local Institution - 136 - Washington D.C.
Kentucky
- Local Institution - 102 - Paducah
Maryland
- Local Institution - 123 - Bethesda
Missouri
- Local Institution - 117 - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2019-01-02 |
| Est. Completion | 2027-09-28 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03682536
The ClinicalTrials.gov registry entry for NCT03682536 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 363 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 283-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (28% higher). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Luspatercept is the first listed.
NCT03682536 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, California, New Jersey.
Frequently Asked Questions
What is clinical trial NCT03682536 about?
NCT03682536 is a clinical study titled "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". 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 ...
What is the current status of trial NCT03682536?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 363 participants. The study started on 2019-01-02. Estimated completion is 2027-09-28.
What conditions does trial NCT03682536 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes.
What interventions are being tested in trial NCT03682536?
The interventions under investigation include: Luspatercept (DRUG), Epoetin alfa (DRUG).
Who is sponsoring clinical trial NCT03682536?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03682536 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndromes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
RECRUITING · Phase 3
-
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 · Phase 3
-
A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants
ACTIVE NOT RECRUITING · Phase 3
-
Erythropoietin (EPO)+/- Filgrastim (G-CSF) vs. Supportive Therapy Alone for Patients With Myelodysplastic Syndromes
COMPLETED · Phase 3
-
A Web-Based Stem Cell Transplant Support System or Standard Care in Young Patients Undergoing Stem Cell Transplant and Their Families
COMPLETED · Phase 3
-
Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.