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Vosaroxin + Azacitidine for Myelodysplastic Syndrome
Study Summary
This trial is testing vosaroxin + azacitidine to treat MDS. Vosaroxin + azacitidine kill cancer cells or stop them from dividing.
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 2009 Phase 2 trial • 113 Patients • NCT00607997Trial Design
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Who is running the clinical trial?
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- Your IPSS score is INT-1 or higher during screening.Your bilirubin level should be lower than 2.0 mg/dl, unless you have Gilbert's disease.My kidney function, measured by creatinine levels or clearance, is within the normal range.I need blood or platelet transfusions due to low blood counts.I can take care of myself but might not be able to do heavy physical work.I am using or will use birth control during and for 30 days after the study.I have myelodysplastic syndrome with specific blood or bone marrow conditions.I am 18 years old or older.I am using or will use birth control during and for 30 days after the study.I am currently undergoing chemotherapy, radiation, or immunotherapy.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My liver and kidney functions are within normal ranges.I am part of, or agree to join, a study collecting blood, bone marrow, and skin samples.I have completed at least four cycles of a specific cancer treatment.I do not have active HIV, HBV (unless from vaccine), or HCV (unless treated and viral load is negative).You are currently pregnant or breastfeeding.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.You understand the study and agree to sign a document that explains it (or have a legal representative sign for you, if needed).My condition is either MDS with 20-29% bone marrow blasts or chronic myelomonocytic leukemia.Your liver function tests (AST and ALT) must be within 2.5 times the normal range.I may have had up to 3 treatments with specific drugs for my condition and received supportive care.
- Group 1: Treatment (vosaroxin, azacitidine)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the primary purpose of vosaroxin?
"Vosaroxin is most often used to treat patients with malignant neoplasms. It can also be useful in treating 20-30% blasts, neutropenia and/or thrombocytopenia, and anemia."
Is this the first time vosaroxin has been looked at in a scientific setting?
"There are presently 181 active trials for vosaroxin in progress, 34 of which have reached Phase 3. Some studies related to vosaroxin are wrapping up in Saint Louis, Missouri; however, there are 5769 other locations conducting research on this medication."
To what degree does vosaroxin put patients at risk?
"Vosaroxin falls into the Phase 1 category on our Power team's safety scale. That means that there is limited clinical data supporting both its efficacy and safety."
Are there any open positions left in this clinical trial?
"According to the listing on clinicaltrials.gov, this trial is not actively recruiting patients at this time. This study was originally posted on November 22nd, 2013 and updated as recently as March 23rd, 2022. There are 1853 other studies that are looking for patients right now."
How many people are being studied in this experiment?
"Unfortunately, this particular clinical trial is not currently looking for new participants. The study was originally posted on November 22nd, 2013 and was last updated on March 23rd, 2022. There are 1672 other studies actively recruiting patients with myelodysplastic syndromes and 181 trials for vosaroxin that are accepting new patients at this time."
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