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: Active Phase 3 study of Myelodysplastic Syndromes, sponsored by Celgene.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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 va
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 |
What the registry record for NCT03682536 still lists
NCT03682536 is an interventional study that assigns participants to a tested intervention. The registered 363 participants enrollment target is mid-sized for trials with a published cap, above the 283-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (28% higher).
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 names 20 study sites across 13 states, led by 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.
Where NCT03682536's enrollment target sits among peer trials
363 12th of 173 higher than 162 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06472245 · 363 participants · Phase 3
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
- NCT04510597 · 364 participants · Phase 3
Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial
- NCT05098132 · 364 participants · Phase 1
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
- NCT05330221 · 364 participants · NA
Project 2: ACHIEVE- HF
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI