Safety and Efficacy of Quizartinib to Treat Acute Myeloid Leukemia (AML)
S
Sandeep Batra, MD
Primary Investigator
Not Recruiting
21 years or below
All
Phase
1/2
3 participants needed
2 Locations
Brief description of study
The main purpose of this study is to gather information about an investigational drug, called quizartinib, that may help to treat AML.
Detailed description of study
Researchers will begin with screening tests to ensure that it is safe for participants to take part in this study.
It is expected that partipants will remain in the hospital throughout treatment.
Participants will receive chemotherapy to prevent or to treat any AML in the brain or spinal fluid. Two chemotherapy drugs called cytarabine and methotrexate plus a steroid drug (prednisolone or hydrocortisone) will be given through Intrathecal (IT) chemotherapy.
In the first cycle, participants will receive 2 chemotherapy drugs, cytarabine and fludarabine by infusion into the vein or venous access device (port) once a day for the first 5 days. Participants will then receive quizartinib by mouth once a day from Day 6 through Day 28.
During this cycle, between 14 ml (about a tablespoon) and 135 ml (about half a cup) of blood may be drawn. After treatment, participants will have one or more bone marrow tests to see if their AML is responding and blood tests to monitor blood counts.
Participants whose AML does not improve after Cycle 1 will not receive Cycle 2 or stem cell transplant (SCT) therapy.
In Cycle 2, participants will receive the same treatment as Cycle 1. During this cycle, between 10 ml (about a 2 teaspoons) and 86 ml (about one third of a cup) of blood may be drawn. After treatment, participants will again have one or more bone marrow tests to see if their AML is responding and blood tests to monitor blood counts.
Participants whose AML does not improve after Cycle 2 may undergo stem cell transplant (SCT) therapy.
Study doctors will monitor participants' health for up to 7 years.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Acute Myeloid Leukemia, AML
-
Age: 21 years or below
-
Gender: All
Individuals between 1 month and 21 years of age, with a diagnosis of Acute Myeloid Leukemia (AML).
Individuals with uncontrolled or significant cardiovascular disease, congenital long QT syndrome, history of clinically significant ventricular arrhythmias, second or third degree heart block, or uncontrolled hypertension, will not be eligible.
Individuals with a systemic infection, HIV, or active liver disease will not be eligible.
Pregnant or breastfeeding women will not be eligible.
Updated on
01 Aug 2024.
Study ID: PHO-COG-CROOP-ADVL1822, 1908739114
