StudyFinder
HM2024-36 A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH INDUCTION AND CONSOLIDATION CHEMOTHERAPY AND ADMINISTERED AS MAINTENANCE THERAPY IN ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD NEGATIVE ACUTE MYELOID LEUKEMIA
Status: Recruiting
The purpose of this research is to test how well the investigational study drug, quizartinib, works in patients with AML without a FLT3-ITD mutation who have not received any prior treatment for the disease. The study will test how it works when taken with standard chemotherapy and then taken alone to prevent the disease from coming back.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• 18 to 70 years old
• newly diagnosed, primary Acute Myeloid Leukemia (AML)
• at least able to walk do selfcare but may be unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• any other type of leukemia
• AML caused by prior chemotherapy or radiotherapy or myelodysplastic syndrome (MDS)
• prior treatment for leukemia, with some exceptions
• see link to clinicaltrials.gov for complete Exclusion criteria
Interventions:
Drug: Chemotherapy, Drug: Placebo, Drug: Quizartinib
Conditions:
Cancer
Keywords:
Acute Myeloid Leukemia, AML, Leukemia, Clinics and Surgery Center (CSC)
Study Contact: Lucas Kauzlarich - kauzl006@umn.edu
Principal Investigator: Naveen Premnath
Phase: PHASE3
IRB Number: STUDY00023711
See this study on ClinicalTrials.gov