Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to long-term post-treatment follow-up (approximately, 5 years)
Awards & highlights
Study 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.Check my eligibility
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).See study design
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 belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment to long-term post-treatment follow-up (approximately, 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to long-term post-treatment follow-up (approximately, 5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events (AEs)
Number of participants developing other malignancies/pre-malignancies
Number of participants progressing to high/very high risk MDS or AML.
+2 moreSecondary outcome measures
Number of participants developing treatment emergent extramedullary hematopoiesis (EMH) masses
Overall Survival
Percentage of participants developing treatment emergent EMH masses
Side effects data
From 2021 Phase 3 trial • 336 Patients • NCT0260443342%
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%
Vomiting
13%
Nausea
13%
Abdominal pain
13%
Dizziness
13%
Myalgia
12%
Asthenia
11%
Abdominal pain upper
11%
Influenza
10%
Hypertension
9%
Dyspepsia
9%
Influenza like illness
9%
Musculoskeletal pain
9%
Nasal congestion
8%
Urticaria
8%
Gastroenteritis
8%
Nasopharyngitis
7%
Toothache
7%
Tonsillitis
7%
Hyperuricaemia
6%
Pain
6%
Urinary tract infection
6%
Viral upper respiratory tract infection
6%
Neck pain
6%
Osteoporosis
5%
Spinal pain
5%
Lethargy
5%
Injection site pain
5%
Menstruation irregular
5%
Alanine aminotransferase increased
5%
Constipation
5%
Transfusion reaction
5%
Liver iron concentration increased
4%
Musculoskeletal chest pain
4%
Fall
2%
Anaemia
1%
Deep vein thrombosis
1%
Extramedullary haemopoiesis
1%
Septic shock
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
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
~1050
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,189 Total Patients Enrolled
Rodrigo Ito, M.D.Study DirectorCelgene Corporation
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,369,215 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health, mental, or legal issues preventing me from joining the study.I am currently pregnant or breastfeeding.You have a condition that may make it difficult to understand the study results.I can have children, will test for pregnancy, and follow the study's birth control rules.I am 18 years old or older.I am a male participant willing to follow the study's rules on sexual activity and contraception.I am not using any medications or undergoing procedures that are not allowed with my current treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ACE-536
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other medical studies involving Luspatercept have already been completed?
"Luspatercept was first trialled in 2018 at Local Institution 102. So far, 8 trials have been completed with 12 more underway. Many of these ongoing trials are based in Cleveland, Ohio."
Answered by AI
Could you detail Luspatercept's safety for human usage?
"Luspatercept clinical trials have yielded some data affirming its efficacy, and there is also evidence from multiple rounds of testing that supports its safety. Consequently, our team has rated Luspatercept's safety at a 3."
Answered by AI
Are there any patients who could still participate in this research project?
"The clinical trial posted on clinicaltrials.gov is actively recruiting patients. The trial was originally posted on 2019-08-12 and was last updated on 2022-10-25."
Answered by AI
In how many different places is this study being conducted?
"Patients are currently being accepted at this study's 16 different locations, which include Cleveland Clinic in Cleveland, Ohio, Weill Cornell Medical College in New york, New York, and Stanford Cancer Center in Stanford, California."
Answered by AI
Is this a new clinical trial?
"There are a dozen ongoing clinical trials for Luspatercept in 109 cities and 34 countries. The first trial occurred in 2018 and was sponsored by Celgene. That initial study had 145 participants and completed its Phase 2 drug approval stage. In the years since 2018, there have been 8 more trials."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger