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Protein Therapy

Long-Term Safety of Luspatercept for Blood Disorders

Phase 3
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is ≥ 18 years at the time of signing the informed consent form (ICF).
Be older than 18 years old
Must not have
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.
Applies to on treatment participants only- Pregnant or breastfeeding females.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to long-term post-treatment follow-up (approximately, 5 years)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is for people who have been taking luspatercept and are tolerate the protocol-prescribed regimen. The study is to evaluate the long-term safety of luspatercept and participants will be followed for safety-related parameters and adverse event reporting.

Who is the study for?
Adults over 18 who have been part of previous luspatercept trials and may benefit from continued treatment. They must understand and consent to study requirements, adhere to visit schedules, and if applicable, use contraception. Excluded are those with conditions that could skew data or at high risk from participation, pregnant/breastfeeding women, or those not compliant with the parent trial.
What is being tested?
The long-term safety of luspatercept is being tested in patients transitioning from earlier trials. The study has three phases: Transition (enrollment), Treatment (same dose as before), and Follow-up (42-day safety check and up to 5 years of survival tracking).
What are the potential side effects?
While specific side effects for luspatercept aren't listed here, common ones in such treatments include fatigue, injection site reactions, muscle aches or pains, headaches, abdominal discomfort or changes in blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any health, mental, or legal issues preventing me from joining the study.
Select...
I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to long-term post-treatment follow-up (approximately, 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to long-term post-treatment follow-up (approximately, 5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events (AEs)
Number of participants developing other malignancies/pre-malignancies
Number of participants progressing to high/very high risk MDS or AML.
+2 more
Secondary study objectives
Overall Survival

Side effects data

From 2021 Phase 3 trial • 336 Patients • NCT02604433
42%
Upper respiratory tract infection
35%
Headache
32%
Back pain
23%
Arthralgia
22%
Bone pain
22%
Cough
21%
Pyrexia
18%
Oropharyngeal pain
18%
Diarrhoea
17%
Fatigue
16%
Pharyngitis
15%
Pain in extremity
13%
Abdominal pain
13%
Nausea
13%
Vomiting
13%
Myalgia
13%
Dizziness
12%
Asthenia
11%
Abdominal pain upper
11%
Influenza
10%
Hypertension
9%
Dyspepsia
9%
Influenza like illness
9%
Musculoskeletal pain
9%
Nasal congestion
8%
Nasopharyngitis
8%
Gastroenteritis
8%
Urticaria
7%
Toothache
7%
Tonsillitis
7%
Hyperuricaemia
6%
Pain
6%
Urinary tract infection
6%
Viral upper respiratory tract infection
6%
Neck pain
6%
Osteoporosis
5%
Constipation
5%
Injection site pain
5%
Transfusion reaction
5%
Alanine aminotransferase increased
5%
Spinal pain
5%
Lethargy
5%
Menstruation irregular
5%
Liver iron concentration increased
4%
Fall
4%
Musculoskeletal chest pain
2%
Anaemia
1%
Septic shock
1%
Extramedullary haemopoiesis
1%
Deep vein thrombosis
1%
Transient ischaemic attack
1%
Cerebrovascular accident
1%
Cholangitis
1%
Cholecystitis acute
1%
Cellulitis
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Luspatercept + BSC
Placebo + BSC

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ACE-536Experimental Treatment1 Intervention
Luspatercept will be administered as a subcutaneous (SC) injection to participants by the study staff at the clinical site and administration will be documented in the subject's source record.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Luspatercept
2018
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
645 Previous Clinical Trials
129,792 Total Patients Enrolled
Rodrigo Ito, M.D.Study DirectorCelgene Corporation
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,570 Previous Clinical Trials
3,384,137 Total Patients Enrolled

Media Library

Luspatercept (Protein Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04064060 — Phase 3
Beta Thalassemia Research Study Groups: ACE-536
Beta Thalassemia Clinical Trial 2023: Luspatercept Highlights & Side Effects. Trial Name: NCT04064060 — Phase 3
Luspatercept (Protein Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04064060 — Phase 3
~260 spots leftby May 2028
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