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NCT04064060 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

A Phase 3 study of Beta-Thalassemia and Myelodysplastic Syndromes (MDS), sponsored by Celgene.

Recruiting
Registry status
Phase 3
Development phase
665
Enrollment target
20
Study locations

NCT04064060 is a Phase 3 study of Beta-Thalassemia and Myelodysplastic Syndromes (MDS) that is actively recruiting participants, run by Celgene. The registered enrollment target is 665 participants, above the 133-participant average among 14 other Beta-Thalassemia trials with a reported enrollment target (400% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT04064060, a Phase 3 study of Beta-Thalassemia and Myelodysplastic Syndromes (MDS), is actively recruiting participants, sponsored by Celgene.

RECRUITING
Registry status
Phase 3
Development phase
665 participants
Enrollment target
20
Study locations

Study Summary

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: * Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept * Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met * The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase * Transition Phase is defined as one Enrollment visit * Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol * Follow-up Phase includes: \- 42 Day Safety Follow-up Visit * During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting \- Long-term Post-treatment Follow-up (LTPTFU) Phase * Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or d

Conditions Studied

Beta-Thalassemia Myelodysplastic Syndromes (MDS) Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis

Interventions

  • DRUG Luspatercept

Study Locations (20)

Other

  • Royal Prince Alfred Hospital - Camperdown
  • Local Institution - 182 - Brasschaat
  • Local Institution - 180 - Bruges
  • Local Institution - 183 - Ghent
  • Local Institution - 184 - Leuven

California

  • Childrens Hospital Los Angeles RHU - Los Angeles
  • Local Institution - 971 - Oakland
  • Local Institution - 978 - Stanford

Florida

  • Local Institution - 975 - Tampa

Illinois

  • Local Institution - 970 - Chicago

Massachusetts

  • Local Institution - 973 - Boston

Michigan

  • Local Institution - 961 - Detroit

New York

  • Local Institution - 969 - New York

Ohio

  • Local Institution - 967 - Cleveland

Trial Details

FieldValue
Enrollment Target 665 participants
Start Date 2019-08-12
Est. Completion 2028-05-12
Phase Phase 3

Sponsor

Celgene

308 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04064060

The ClinicalTrials.gov registry entry for NCT04064060 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 665 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 133-participant average among 14 other Beta-Thalassemia trials with a reported enrollment target (400% higher). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Beta-Thalassemia appearing as the primary indexed condition, and to 1 intervention - of which Luspatercept is the first listed.

NCT04064060 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04064060 about?

NCT04064060 is a clinical study titled "A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials". A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: * Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the p...

What is the current status of trial NCT04064060?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 665 participants. The study started on 2019-08-12. Estimated completion is 2028-05-12.

What conditions does trial NCT04064060 study?

This clinical trial studies the following conditions: Beta-Thalassemia, Myelodysplastic Syndromes (MDS), Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis.

What interventions are being tested in trial NCT04064060?

The interventions under investigation include: Luspatercept (DRUG).

Who is sponsoring clinical trial NCT04064060?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04064060 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.