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Protein Therapeutics
Luspatercept for Myelofibrosis (INDEPENDENCE Trial)
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
RBC transfusions are scored in determining eligibility when given for treatment of symptomatic anemia with a pretransfusion Hgb ≤ 9.5 g/dL or asymptomatic anemia with a pretransfusion Hgb ≤ 7 g/dL.
a. Average RBC-transfusion frequency: 4 to 12 RBC units/12 weeks immediately up to randomization. There must be no interval > 6 weeks (42 days) without ≥ 1 RBC transfusion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
INDEPENDENCE Trial Summary
This trial is studying how well luspatercept works in treating patients with myeloproliferative neoplasm-associated myelofibrosis and anemia who are on concomitant Janus kinase 2 inhibitor therapy and who require red blood cell count transfusions.
Who is the study for?
Adults diagnosed with Myelofibrosis associated with a myeloproliferative neoplasm, on stable JAK2 inhibitor therapy, needing regular blood transfusions due to anemia. Participants must have adequate organ function and not be pregnant or breastfeeding. They should agree to contraception if of childbearing potential and not have other significant health issues that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing Luspatercept (ACE-536) against a placebo in subjects who are anemic as part of their myelofibrosis condition while already taking JAK2 inhibitors. The study includes several phases: initial treatment, response assessment, possible unblinding for non-responders, and follow-up.See study design
What are the potential side effects?
While specific side effects for Luspatercept aren't listed here, similar medications can cause reactions at injection sites, tiredness, headache, muscle or joint pain. There's also a risk of more serious effects like high blood pressure or abnormal liver tests.
INDEPENDENCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received blood transfusions for low hemoglobin levels.
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I've had 4 to 12 blood transfusions in the last 3 months without going more than 6 weeks without one.
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I have been on a stable dose of JAK2 inhibitor for my condition for at least 16 weeks.
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I need regular blood transfusions, getting 4 to 12 units every 3 months without going more than 6 weeks between them.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My condition is officially diagnosed as primary or secondary myelofibrosis.
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My condition is officially diagnosed as primary or secondary myelofibrosis.
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I am a man who will not have sex or will use a condom with women who can get pregnant.
INDEPENDENCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 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
Blood Transfusion
Secondary outcome measures
Change in RBC transfusion burden
Change in serum ferritin from baseline
Cumulative duration of RBC-transfusion independence
+12 moreINDEPENDENCE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental Arm: Luspatercept (ACE-536)Experimental Treatment1 Intervention
Luspatercept will be given to participants via subcutaneous injection (administered on Day 1 of each 21-day treatment cycle)
Group II: Control Arm: PlaceboPlacebo Group1 Intervention
Placebo starting dose with volume equivalent to experimental arm subcutaneous injection every 3 weeks (administered on Day 1 of each 21-day treatment cycle)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACE-536
2013
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,545 Total Patients Enrolled
Torsten Gerike, MDStudy DirectorBristol-Myers Squibb
1 Previous Clinical Trials
95 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,369,514 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a major bleeding event in the last 6 months.I haven't had a stroke, heart attack, or blood clots in the past 6 months.My heart condition is not well-managed, and my heart's pumping ability is weak.I have been cancer-free from other types of cancer for over 3 years.If you are sexually active with the opposite gender, you must agree to use effective contraception without interruption during the study and for 12 weeks after the study ends. If you choose not to use contraception, you must commit to not having any sexual contact and have it documented every month.I do not have any uncontrolled infections.I have not participated in any experimental trials or used investigational drugs/devices within the last 30 days or five half-lives of the drug.I am a male willing to use contraception or practice abstinence during and after the study for 12 weeks.I have received blood transfusions for low hemoglobin levels.I have had or will have a bone marrow transplant within 6 months.If you are a woman, you need to take two pregnancy tests before starting the study. You will also need to continue taking pregnancy tests during the study, and after the treatment has ended, even if you are not sexually active.I've had 4 to 12 blood transfusions in the last 3 months without going more than 6 weeks without one.I have anemia causing tiredness or breathlessness, or my hemoglobin is very low without symptoms.I have been on a stable dose of JAK2 inhibitor for my condition for at least 16 weeks.I practice true abstinence as a lifestyle choice.I need regular blood transfusions, getting 4 to 12 units every 3 months without going more than 6 weeks between them.You have a serious medical condition, abnormal lab results, or a mental health condition that could affect your ability to participate in the study. You may also be excluded if local regulations consider you to be vulnerable.I can have children, have had 2 negative pregnancy tests, and will use birth control or abstain.I have not had major surgery in the last 2 months.I have been on a stable dose of iron chelation therapy for the last 8 weeks.My anemia is not caused by myeloproliferative neoplasm treatment.I haven't taken drugs affecting blood cell production in the last 8 weeks.My blood pressure is not controlled by medication.I have been on a stable dose of JAK2 inhibitor for at least 16 weeks and can continue for 24 more.I have not had RBC transfusions for anemia caused by bleeding or infections.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.My condition is officially diagnosed as primary or secondary myelofibrosis.I have HIV or active Hepatitis B/C.I don't have any health issues or take medications that would affect the study's results.My condition is officially diagnosed as primary or secondary myelofibrosis.I am a man who will not have sex or will use a condom with women who can get pregnant.I am on a stable dose of steroids, not more than 10 mg of prednisone, for the last 4 weeks.I have previously been treated with luspatercept or sotatercept.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm: Luspatercept (ACE-536)
- Group 2: Control Arm: Placebo
Awards:
This trial has 1 awards, including:- 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.
How many research subjects are allowed in this trial?
"The sponsor, Celgene, will be conducting this study from multiple sites. The full 309 patients that meet the inclusion criteria must be recruited in order to execute the study. Two examples of these recruiting sites include University of Alabama at Birmingham in Birmingham, Alabama and Local Institution - 183 in Vancouver, British Columbia."
Answered by AI
If a patient wanted to enroll in this trial, could they?
"The clinicaltrials.gov website lists this study as currently searching for patients. The trial was first posted on February 25th, 2021 and was last edited on November 15th, 2022."
Answered by AI
Are there any short or long-term risks associated with taking ACE-536?
"Given that this is a Phase 3 trial with both efficacy and safety data, our team has given ACE-536 a score of 3 for safety."
Answered by AI
Are there other locations where this experiment is taking place?
"There are a total of 32 institutions running this clinical trial. Some notable locations include University of Alabama at Birmingham in Birmingham, Local Institution - 183 in Vancouver, and Rush University Medical Center in Chicago."
Answered by AI
What other scientific research has been conducted on ACE-536?
"The first study for ACE-536 was completed in 2018 at Local Institution - 102. Since then, a total of 18294 studies have been conducted. There are 12 ongoing trials as of now, with many of them taking place in Birmingham, Alabama."
Answered by AI
What other similar trials exist for this medication?
"At present, there are a dozen ongoing clinical trials for ACE-536 in 110 cities and 34 countries. The first such study was completed in 2018 by Celgene Corporation; it reached Phase 2 approval after enrolling 145 participants. Since then, 18294 more studies have been conducted."
Answered by AI
Who else is applying?
What site did they apply to?
University Of Kentucky Markey Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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