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Protein Therapeutics
Luspatercept for Myelodysplastic Syndrome-related Anemia
Phase 2
Recruiting
Led By Rami Komrokji, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment, up to 18 months
Awards & highlights
Study Summary
This trial will test if luspatercept can reduce the need for blood transfusions in participants with anemia caused by MDS or MDS/MPN. It will also assess the safety and tolerability of luspatercept.
Who is the study for?
This trial is for adults with certain types of bone marrow disorders (MDS or MDS/MPN) that cause anemia and require regular blood transfusions. Participants must have specific genetic mutations, not be pregnant or breastfeeding, and cannot have severe kidney issues or other active cancers. They should not have had prior stem cell transplants and must agree to contraception if applicable.Check my eligibility
What is being tested?
The study tests whether Luspatercept plus supportive care reduces the need for blood transfusions in patients with anemia due to MDS or MDS/MPN. It also assesses the safety and side effects of Luspatercept in these patients.See study design
What are the potential side effects?
While the specific side effects are not listed here, generally such treatments may include risks like fatigue, injection site reactions, muscle aches, headaches, nausea, high blood pressure, dizziness and potential risk of developing new or worsening tumors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of treatment, up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment, up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
RBC Transfusion Independence
Secondary outcome measures
ASC specks changes with response
Duration of Response
Hematological Improvement
+1 moreSide 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
2Treatment groups
Experimental Treatment
Group I: Participants with gene mutations other than SF3B1Experimental Treatment1 Intervention
Participants with lower risk MDS or non-proliferative MDS/MPN with somatic splicing gene mutations other than SF3B1
Group II: Participants with SF3B1 mutationExperimental Treatment1 Intervention
Participants with lower risk MDS or non-proliferative MDS/MPN with SF3B1 mutation who had received hypomethylating agents and or lenalidomide.
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?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,422 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,930 Total Patients Enrolled
Rami Komrokji, MDPrincipal InvestigatorMoffitt Cancer Center
5 Previous Clinical Trials
225 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My condition is classified as very low, low, or intermediate risk.I have an SF3B1 mutation and was treated with hypomethylating agents or lenalidomide.My MDS is linked to a specific genetic change and I haven't had lenalidomide.I have had a stem cell transplant before.My kidney function is severely impaired.My cancer has a specific gene mutation related to splicing.My cancer has a specific genetic mutation, but not SF3B1.I have another active cancer besides the one being treated.I have previously been treated with Luspatercept or Sotatercept.I stopped taking ESAs, G-CSF, GM-CSF at least 4 weeks ago.I cannot take or did not respond to previous ESA treatment.My high blood pressure is not controlled, even with treatment.I am a male and will either not have sex or use a condom with women who can get pregnant.I have been diagnosed with MDS or MDS/MPN with a WBC count under 13,000.I've needed blood transfusions (2 units every 8 weeks) for the last 16 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with gene mutations other than SF3B1
- Group 2: Participants with SF3B1 mutation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Could you please provide information about the enrollment eligibility for this project?
"Clinicaltrials.gov asserts that this trial, which was initially made public on February 8th 2023, is currently searching for participants with the most recent edit occuring on February 16th 2023."
Answered by AI
Does the FDA recognize any additional genetic mutations for this treatment?
"Since there is some data confirming the safety of participants with gene mutations other than SF3B1, but none confirming efficacy, our team assigned it a rating of 2."
Answered by AI
To what extent has participation been demonstrated in this clinical experiment?
"Affirmative. According to the information on clinicaltrials.gov, this investigation is actively searching for suitable participants; it was originally posted in February 8th 2023 and last updated a week later. The trial needs 70 recruits from 1 medical centre."
Answered by AI
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