Study on Quizartinib or Placebo with Chemotherapy for Newly Diagnosed Patients with FLT3-ITD Negative Acute Myeloid Leukemia (AML)
Sponsor: Daiichi Sankyo
ClinicalTrials ID:NCT06578247
This clinical trial is comparing the effects of the drug Quizartinib versus a placebo, both combined with chemotherapy, in adults newly diagnosed with a specific type of acute myeloid leukemia (AML) that does not have the FLT3-ITD mutation.
Patient Parameters
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Program Overview
The purpose of this study is to see if adding Quizartinib to standard chemotherapy can improve survival in adults who have been newly diagnosed with acute myeloid leukemia (AML) that is negative for the FLT3-ITD mutation. Participants will receive either Quizartinib or a placebo along with chemotherapy and will be monitored to see how long they live after treatment. The study will also involve testing participants for the FLT3-ITD mutation using a special lab test.
Description
This clinical trial is designed to compare the effects of Quizartinib, a drug, with a placebo when both are used alongside standard chemotherapy in adults who have just been diagnosed with a type of acute myeloid leukemia (AML) that does not have the FLT3-ITD mutation. The main goal is to see if Quizartinib can help patients live longer. Participants will receive either Quizartinib or a placebo during their chemotherapy treatment and as a maintenance therapy for up to 36 cycles. Before starting the trial, participants will be tested to confirm they do not have the FLT3-ITD mutation.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand and sign a consent form approved by an ethics committee or review board before any trial-specific procedures.
- Must be 18 years or older, up to 70 years old.
- Must have a new diagnosis of primary acute myeloid leukemia (AML) as defined by the World Health Organization.
- Must have a performance status score of 0 to 2, indicating they are fully active or have some limitations but are still able to care for themselves.
- Must be receiving the standard "7+3" induction chemotherapy regimen as part of the study protocol.
Exclusion Criteria
- Cannot have a diagnosis of acute promyelocytic leukemia (APL) or other specific types of leukemia.
- Cannot have AML that developed after previous chemotherapy or radiation for other cancers or conditions.
- Cannot have AML that developed from other blood disorders like myelodysplastic syndrome (MDS) or myeloproliferative neoplasms (MPN).
- Cannot have AML with FLT3-ITD mutations present at a certain level.
- Cannot have received prior treatment for AML, except for certain allowed treatments like leukapheresis, treatment for high white blood cell counts, cranial radiotherapy, preventive chemotherapy for the central nervous system, or growth factor support.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Phoenix | 85338 | Goodyear | Arizona |
| Mayo Clinic - Phoenix | 85054 | Phoenix | Arizona |
| University of Arizona Cancer Center | 85724 | Tucson | Arizona |
| Ucsf - School of Medicine | 94115 | San Francisco | California |
| Stanford University School of Medicine- Parent | 94305 | Stanford | California |
| Colorado Blood Cancer Institute | 80218 | Denver | Colorado |
| Yale University | 06510 | New Haven | Connecticut |
| Mayo Clinic Hospital | 32224 | Jacksonville | Florida |
| Florida Hospital Cancer Institute - Kissimmee | 34741 | Kissimmee | Florida |
| Tampa General Hospital | 33606 | Tampa | Florida |
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