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Luspatercept +/− Hydroxyurea for Myeloproliferative Disorders
Study Summary
This trial is testing the effects of luspatercept with or without hydroxyurea on patients with myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis or unclassifiable with ring sideroblasts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 3 trial • 336 Patients • NCT02604433Trial Design
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Who is running the clinical trial?
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- I can't use or didn't respond to drugs for anemia related to my condition.I haven't taken luspatercept-aamt or sotatercept, but may have had other treatments.I have been diagnosed with a specific type of blood disorder that includes ringed sideroblasts.My kidney function, measured by creatinine clearance, is adequate.I can take care of myself and perform daily activities.I haven't had chemotherapy or similar treatments in the last 2 weeks.I've needed blood transfusions or have had symptoms of anemia recently.I have not had surgery to remove my uterus or both ovaries.Your hemoglobin levels are too low (less than 9.5 g/dL) as measured within the last 14 days before the trial starts.I have received specific previous treatments.I do not have any severe illnesses other than heart issues.I had surgery less than 3 weeks ago.I do not have any current infections.My high blood pressure is not controlled even with three or more medications.I need constant oxygen because of severe breathing problems from my advanced illness.I have anemia that causes symptoms due to poor nutrition or bleeding.I am immunocompromised or HIV positive and on antiretroviral therapy.I am not on any treatments for my condition, except possibly hydroxyurea, within the last 2 weeks.I haven't had any other cancer except breast or prostate cancer treated with hormones in the last 3 years.I have had skin cancer or cervical cancer but am not currently receiving treatment for any other cancer.I haven't had a heart attack, stroke, or serious clotting issue in the last 6 months.I am 18 years old or older.I have been diagnosed with a specific type of blood disorder that includes ringed sideroblasts.I haven't taken luspatercept-aamt or sotatercept, but I may have had other treatments.I can take care of myself and am up and about more than half of my waking hours.I've needed blood transfusions or have had symptoms of anemia recently.My kidney function, measured by creatinine clearance, is adequate.I am a woman capable of becoming pregnant.I have started my menstrual periods.I practice true abstinence as a lifestyle choice.I am a male participant.I practice true abstinence as a lifestyle choice.I am not pregnant, breastfeeding, or planning to become pregnant.Your recent blood test shows that your bilirubin levels are within the normal range.I am 18 years old or older.Your liver function tests (ALT and AST) must not be more than three times the upper limit of normal (or not more than five times for patients with liver involvement) and the results must be obtained within 14 days before the start of the trial.
- Group 1: Cohort A (luspatercept)
- Group 2: Cohort A (luspatercept, hydroxyurea)
Frequently Asked Questions
Are new participants still being welcomed into this research project?
"Yes, the information on clinicaltrials.gov suggests that this trial is actively searching for participants. The clinical trial was originally posted on 1/17/2022 and was last updated on 1/19/2022. The study is admitting 54 patients across 1 locations."
How many individuals have signed up for this research project?
"That is correct. The listing on clinicaltrials.gov reveals that this study is looking for 54 individuals at 1 location. This information was first posted on January 17th, 2022 and was most recently updated on January 19th, 2022."
When might we see Luspatercept hit the market?
"Luspatercept was given a safety score of 2 because, while there is data supporting its safety, none of it points to the efficacy of the medication."
What are the standard applications for Luspatercept?
"Luspatercept is not only effective in treating anemia, but also chemoradiation, thrombocythemia, essential, and meningiomas."
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