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Daunorubicin for Acute Lymphoblastic Leukemia
Study Summary
This trial is testing a lower dose of the chemotherapy drug daunorubicin given over 5 days, to see if it's less toxic than the standard dose given over 3 days.
- Refractory Acute Lymphoblastic Leukemia
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Acute Myelogenous Leukemia
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 657 Patients • NCT00049517Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Is the enrollment phase of this trial still open to volunteers?
"Affirmative - clinicaltrials.gov reveals that this medical trial is actively enrolling participants. The study was initiated on May 8th 2020 and the most recent update occurred July 1st 2022; it seeks to enrol 10 patients from one site."
What is the intended outcome of this research endeavor?
"The primary aim of this two-year trial is to evaluate the pro/anti-cancer cellular immune response in patients with relapsed or refractory acute leukemia upon targeted anthracycline treatment. Secondary objectives include exploring pharmacokinetic parameters such as time at maximum concentration, maximum concentration, and elimination half-life through serial daunorubicin level evaluations taken before infusion and at multiple intervals post administration."
Has Daunorubicin been investigated in other research studies?
"Presently, 104 studies are being conducted on Daunorubicin with 35 reaching the third phase. Houston is a major city for research related to this drug; however, 7437 medical centres across the United States of America are currently running trials."
What medical conditions can Daunorubicin be employed to alleviate?
"Primarily prescribed for lymphoma, daunorubicin can additionally be used to alleviate the symptoms of Ewing's tumor, newly diagnosed therapy-related acute myeloid leukemia, and ALL (acute lymphoblastic leukemia)."
Has the FDA sanctioned Daunorubicin for clinical usage?
"Although there is some evidence to suggest that Daunorubicin is safe, as this study has only reached Phase 2 trials and without any data backing efficacy yet, its safety rating was determined to be a score of 2."
Is this medical study open to applicants aged eighty-five and above?
"As indicated by the eligibility requirements, individuals must be between 1 year old and 21 years of age to partake in this clinical trial."
How many participants have been enrolled in this clinical trial thus far?
"Affirmative. The particulars posted on clinicaltrials.gov verify that this medical study, initially published on 8th May 2020, is actively accepting volunteers. 10 test subjects are necessary to be enrolled from a single institution."
Do I meet the criteria to join in this research endeavor?
"This particular trial is accommodating a maximum of 10 patients suffering from acute leukemia, aged between 1 and 21 years old. To be eligible for participation they must have received two prior therapeutic attempts that were ineffective or been in relapse more than once but unable to receive intensive care at the time of consent. Upfront therapies are allowed as well as pulse steroids lasting 5 days or less given during routine maintenance therapy."
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