A Phase 3b, Open-label, Single-arm, Rollover Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials
ClinicalTrials.gov processed this data on December 18, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified December 2024 by Celgene
Sponsor
CelgeneInformation Provided by (Responsible Party)
CelgeneClinicaltrials.gov Identifier
NCT04064060Other Study ID Numbers: ACE-536-LTFU-001
First Submitted: August 9, 2019
First Posted: August 21, 2019
Last Update Posted: December 20, 2024
Last Verified: December 2024
History of Changes
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Study Description
Not Provided| Condition or Disease | Intervention/Treatment |
|---|---|
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Study Design
| Study Type | Interventional |
|---|---|
| Anticipated Enrollment | 665 participants |
| Design Allocation | N/A |
| Interventional Model | Single Group Assignment |
| Masking | None (Open Label) |
| Primary Purpose | Treatment |
| Official Title | A Phase 3b, Open-label, Single-arm, Rollover Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials |
| Study Start Date | August 12, 2019 |
| Anticipated Primary Completion Date | May 12, 2028 |
| Anticipated Study Completion Date | May 12, 2028 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
|---|---|
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Outcome Measures
Primary Outcome Measures
- Adverse Events (AEs) [From enrollment until at least 42 Day Safety Follow-up Phase] Type, frequency, severity of AEs, relationship of treatment emergent adverse events to luspatercept
- Number of participants progressing to high/very high risk MDS or AML. [Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)] Progression to high/very high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) (MDS and myelofibrosis [MF] only).
- Percentage of participants progressing to high/very high risk MDS or AML [Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)] Progression to high/very high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) (MDS and myelofibrosis [MF] only)
- Number of participants developing other malignancies/pre-malignancies [Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)] Development of other malignancies/pre-malignancies
- Percentage of participants developing other malignancies/pre-malignancies [Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)] Development of other malignancies/pre-malignancies
Secondary Outcome Measures
- Overall Survival [Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)] Time from date of randomization until death from any cause
- Number of participants developing treatment emergent extramedullary hematopoiesis (EMH) masses [Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)]
- Percentage of participants developing treatment emergent EMH masses [Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)]
Eligibility Criteria
| Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
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| Exclusion Criteria |
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Contacts and Locations
| Sponsors and Collaborators | Celgene |
|---|---|
| Locations |
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| Investigators |
More Information
Additional Information
Additional Relevant MeSH Terms
- Preleukemia
- Myelodysplastic Syndromes
- Primary Myelofibrosis
- Thalassemia
- Myeloproliferative Disorders
- beta-Thalassemia
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Anemia
- Hemoglobinopathies
- Genetic Diseases, Inborn