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Isatuximab for Acute Lymphoblastic Leukemia (ISAKIDS Trial)
ISAKIDS Trial Summary
This trial is testing the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML).
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
ISAKIDS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowISAKIDS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 307 Patients • NCT02990338ISAKIDS Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Has Isatuximab received government sanctioning for therapeutic use?
"Isatuximab's safety is based on some data from Phase 2 trials, so it received a score of 2."
Are patients that are beyond a certain age able to partake in this research?
"According to the age requirements for this clinical trial, eligible participants must be 28 days old or younger and no older than 17."
What are some of the common illnesses that Isatuximab has been known to effectively treat?
"Isatuximab is frequently used to manage macular edema but can also be given as treatment for other conditions such ulcerative colitis, pheochromocytomas, and certain eye conditions."
Are there any current vacancies in this clinical trial for new patients?
"Yes, as of today this clinical trial is still recruiting patients. The latest update on the study was posted on November 15th, 2022 and it was first made available to the public on August 6th, 2019."
If I qualify, may I participate in this research project?
"This study is looking for 96 participants that have a history of acute lymphoblastic leukemia (ALL), are aged 28 days to 17 years, and have relapsed or are refractory to most recent treatment. Other important requirements include being in first or second relapse and having a white blood cell count below 20 x109/L on Day 1 before isatuximab administration."
At how many locations is this experiment being conducted?
"There are a total of 14 enrolling patients for this clinical trial, which includes locations such as Investigational Site Number 8400004 in Cincinnati, Seattle Childrens Hospital and Regional Medical Center-Site Number:8400003 in Seattle, and Cincinnati Children's Hospital Medical Center-Site Number:8400004 in Dallas."
What are some other papers which mention Isatuximab specifically?
"Isatuximab was first explored in 1997 by Spectrum Health Hospital - Butterworth Campus. With 4074 trials completed, it is one of the most widely studied drugs. At the moment, 2100 clinical trials are underway with a large majority hosted out of Cincinnati, Ohio."
Is this research novel in any way?
"More than two thousand ongoing studies involving isatuximab are being conducted in nearly one hundred countries and three thousand cities. The first study, sponsored by Alfacell Corporation, was completed in 1997 with 300 patients. It reached Phase 3 approval that year. In the 24 years since then, 4,074 total studies have been concluded."
How many research participants will this study be able to accommodate?
"In order to proceed, the study sponsor (Sanofi) needs a total of 96 eligible patients. These subjects will be recruited from multiple clinical sites; for example, 8400004 in Cincinnati, Ohio and 8400003 at Seattle Childrens Hospital."
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