Study on Two Different Doses of Quizartinib for Maintenance in Acute Myeloid Leukemia Patients in Complete Remission
Sponsor: Daiichi Sankyo
ClinicalTrials ID:NCT06824168
This clinical trial is testing two different doses of the drug quizartinib to see how well they work as maintenance therapy for patients with a specific type of acute myeloid leukemia (AML) who are in complete remission and have not had a stem cell transplant.
Patient Parameters
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Program Overview
The study aims to evaluate the effectiveness of two doses of quizartinib as a maintenance treatment for patients with a specific genetic mutation in acute myeloid leukemia (AML) who are in their first complete remission and have not undergone a stem cell transplant. The trial will also include a sub-study to assess the impact of the drug on heart rate and cardiac safety.
Description
This study involves testing two different doses of the drug quizartinib to see how well they work as a maintenance treatment for patients with a specific type of acute myeloid leukemia (AML) who are in complete remission. The study will also look at how the drug affects heart rate and heart health. Participants will be monitored for any changes in their heart rate to ensure the drug is safe for their heart.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Newly diagnosed with a specific type of acute myeloid leukemia (AML) or AML that developed from other blood disorders.
- Have a confirmed genetic mutation called FLT3-ITD in their leukemia cells.
- Currently in complete remission, meaning no signs of leukemia in the bone marrow or blood.
- Have recovered blood counts to specific levels.
- Have received at least one but no more than two cycles of initial chemotherapy to achieve remission.
- Have not received more than four cycles of follow-up chemotherapy.
- Able to start maintenance treatment within 60 days of the last chemotherapy cycle.
- In good overall health with a performance status score of 0 to 2.
Exclusion Criteria
- Have a type of leukemia called acute promyelocytic leukemia (APL) or other specific genetic types of leukemia.
- Developed AML as a result of previous cancer treatments.
- Have received a stem cell transplant as part of AML treatment.
- Have significant heart problems, such as abnormal heart rhythms, recent heart attack, or severe heart failure.
- Have uncontrolled high blood pressure.
- Are taking certain medications that affect how the body processes drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| John Hopkins School of Medicine | 21287 | Baltimore | Maryland |
| Umass Memorial Health Care Systems | 01655 | Worcester | Massachusetts |
| Roswell Park Cancer Institute | 14263 | Buffalo | New York |
| Weill Cornell | 10021-9800 | New York | New York |
| Westchester Medical College | 10595 | Valhalla | New York |
| Clinical Research Allicance | 11590 | Westbury | New York |
| Spoknwrd Clinical Trials Inc. | 18045 | Easton | Pennsylvania |
| The Methodist Hospital Research Institute | 77030 | Houston | Texas |
| The University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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