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Looking for participantsPhase3

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

Sponsor: Celgene

NCT ID: NCT04064060

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Luspatercept (drug)
How long the study runs
Study runs about 105 months (dates as stated)
About the drug or intervention
Luspatercept — drug: Luspatercept (ACE-536), an erythroid maturation agent, is a recombinant fusion protein consisting of a modified form of the extracellular domain (ECD) of the human activin receptor type IIB (ActRIIB) linked to the human immunoglobin G 1 (IgG1) Fc domain.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at the long-term safety of luspatercept (also called ACE-536) in people who have already taken part in an earlier luspatercept trial. It covers people with myelodysplastic syndromes (MDS), beta-thalassemia, or myelofibrosis linked to a myeloproliferative neoplasm (MPN). The sponsor is Celgene.

Who can take part

  • Age 18 or over when signing the consent form
  • Currently in a luspatercept trial and meeting that trial's requirements
  • Either still benefiting from luspatercept and advised to keep taking it, or moving from a dummy medicine (placebo) to luspatercept, or entering the follow-up part of the study
  • Willing and able to attend study visits and follow the study rules
  • Understands and signs a consent form before any study tests are done
  • Has followed the rules of the earlier trial well, in the researcher's view
  • For people taking treatment: women who can become pregnant must have negative pregnancy tests before starting and during the study, and use highly effective contraception from 35 days before starting, during treatment, and for 84 days after stopping
  • For people taking treatment: men must use a condom during sex with a woman who is pregnant or could become pregnant, during the study and for at least 84 days after stopping treatment, even after a vasectomy

Who may not be able to

  • Taking other medicines or treatments not allowed in the earlier luspatercept trial (for those on treatment)
  • Meeting any of the stopping rules from the earlier luspatercept trial
  • A gap of more than 26 days between the last luspatercept dose in the earlier trial and the first dose in this study, unless dose rules allow it (for those on treatment)
  • Pregnant or breastfeeding women (for those on treatment)
  • A serious medical condition, abnormal test result, mental illness, or being seen as vulnerable under local rules (for example, in prison or an institution) that would stop them taking part
  • Any condition or abnormal test result that would make taking part too risky
  • Any condition that would make the study results hard to interpret

What taking part involves

  • • Continuing luspatercept treatment, or switching from placebo to luspatercept, or entering a follow-up phase (long-term post-treatment follow-up)
  • • Regular study visits and following the study schedule

Time commitment: Not stated exactly how often visits happen or how long the study lasts — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
665
Started
2019-08-12
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for myelodysplastic syndromes (mds)
  • • Phase3 - 665 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with myelodysplastic syndromes (mds)

Where?

  • • Aberdeen - Local Institution - 925
  • • Leeds - Local Institution - 921
  • • London - Local Institution - 923
  • • London - Whittington Hospital
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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 disease related therapies should be collected at the same time schedule Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study. The ACE-536-LTFU-001 rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill 5 years on the study, including treatment and follow-up.

Myelodysplastic Syndromes (MDS)Beta-thalassemiaMyeloproliferative Neoplasm(MPN)-Associated Myelofibrosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

mettwo negative

What the study is looking for

  • ✓Participants must meet all the following criteria to be enrolled in this study:
  • ✓Participant is ≥ 18 years at the time of signing the agreement to take part form (ICF).
  • ✓Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
  • ✓Participant has been participating in a luspatercept trial and continues to fulfill all the requirements of the...
  • ✓Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and...

Who cannot take part

  • ✗The presence of any of the following will exclude a participant from enrollment:
  • ✗Applies to on treatment participants only- Concomitant use of any medications/procedures that are prohibited in the...
  • ✗Participant has met one or more criteria for study discontinuation as stipulated in the parent luspatercept protocol.
  • ✗Applies to on treatment participants only- Pregnant or breastfeeding females.
  • ✗Participant has any condition including the presence of laboratory abnormalities, which places the subject at...
See the full criteria
Inclusion Criteria: Participants must meet all the following criteria to be enrolled in this study: 1. Participant is ≥ 18 years at the time of signing the informed consent form (ICF). 2. Participant is willing and able to adhere to the study visit schedule and other protocol requirements. 3. Participant has been participating in a luspatercept trial and continues to fulfill all the requirements of the parent protocol and the participant has been either: 1. Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and should continue to receive luspatercept treatment, OR 2. Assigned to placebo arm in the parent protocol (at the time of unblinding or in follow-up) and should cross over to luspatercept treatment, OR 3. Assigned to the Follow-up Phase of the parent protocol, previously treated with luspatercept or placebo in the parent protocol who shall continue into LTPTFU phase in the rollover study until the follow-up commitments are met (unless requirements are met as per parent protocol to crossover to luspatercept treatment). 4. Participant understands and voluntarily signs an informed consent document prior to any study-related assessments or procedures being conducted. 5. Participant demonstrates compliance, as assessed by the investigator, with the parent study protocol requirements. 6. Applies to on treatment Participants only- females of childbearing potential (FCBP) defined as a sexually mature woman who: 1\) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or amenorrhea due to other medical reasons does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must: 1. Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the participant practices true abstinence from heterosexual contact. 2. Agrees to use, and be able to comply with highly effective, contraception without interruption, 35 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 84 days after discontinuation of study therapy. 7\. Applies to on treatment participants only- Male participants must: a. Agrees to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 84 days following investigational product discontinuation even if he has undergone a successful vasectomy. Exclusion Criteria: The presence of any of the following will exclude a participant from enrollment: 1. Applies to on treatment participants only- Concomitant use of any medications/procedures that are prohibited in the parent luspatercept protocol. 2. Participant has met one or more criteria for study discontinuation as stipulated in the parent luspatercept protocol. 3. Applies to on treatment participants only- More than 26 days between last luspatercept dose in the parent protocol and first dose into ACE-536-LTFU-001 protocol unless dose delay or dose discontinuation criteria met. 4. Applies to on treatment participants only- Pregnant or breastfeeding females. 5. Participant has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (eg, imprisoned or institutionalized) that would prevent the subject from participating in the study. 6. Participant has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 7. Participant has any condition that confounds the ability to interpret data from the study.

Where Is This Study? (9 UK sites)

Local Institution - 925

Aberdeen AB25 2ZN, United Kingdom

COMPLETED

Local Institution - 921

Leeds LS9 7TF, United Kingdom

WITHDRAWN

Local Institution - 923

London E1 1BB, United Kingdom

COMPLETED

Whittington Hospital

London N19 5NF, United Kingdom

Recruiting
Site contact (verified)
Emma Drasar, Site 920+4402072723070

University College London Hospitals NHS Foundation Trust - University College Hospital

London NW1 2BU, United Kingdom

Recruiting
Site contact (verified)
John Porter, Site 9228076846044

Local Institution - 928

London SE1 9RT, United Kingdom

COMPLETED

Local Institution - 924

London SE5 9RS, United Kingdom

COMPLETED

Local Institution - 929

Oxford OX3 7LE, United Kingdom

WITHDRAWN

Local Institution - 926

Sutton in Ashfield NG17 4JL, United Kingdom

WITHDRAWN

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-06