Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia

Launched by GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for adults with a specific type of leukemia called FLT3-positive acute myeloid leukemia (AML). The main goal is to see if a medication called gilteritinib, combined with chemotherapy, can help more patients go into complete remission, meaning their cancer is no longer detectable. Participants in the study will receive gilteritinib along with a chemotherapy regimen for up to two cycles, followed by additional treatment to help keep the cancer from coming back.

To be eligible for this trial, participants must be between 18 and 65 years old and have a confirmed diagnosis of FLT3-positive AML. They should also be in fairly good health overall, with good functioning of the heart, kidneys, and liver. Participants will need to provide consent to join the study and agree to follow the treatment schedule and requirements. It's important to note that this trial is not yet recruiting participants, so there will be some time before anyone can enroll. If you're interested or have questions about eligibility, it's best to talk with your healthcare provider.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The patient is ≥ 18 and ≤65 years old.
• • 2. The patient has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2.
• 3. The patient has adequate baseline organ function, including cardiac, renal, and hepatic function:
• • 1. Left ventricular ejection fraction (LVEF) ≥institutional lower limit of normal as measured by multigated acquisition (MUGA) scan or 2-dimensional (2-D) echocardiography (ECHO) within 21 days before start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG).
• • 2. ECG: QTcF≤450 male ≤480 female
• • 3. Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate of \> 50 mL/min as calculated by the Modification of Diet in Renal Disease equation.
• • 4. Bilirubin ≤3 times the upper limit of normal ULN mg/dL except for Gilbert's condition
• • 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)., except if due to leukemic involvement.
• • 4. Patient is positive at diagnosis for FLT3 activating mutation in bone marrow or whole blood.
• • 5. Diagnosis of untreated AML according to WHO 2016, non-APL
• • 6. If the patient is a woman of childbearing potential (WOCBP), she must have a negative serum or urine pregnancy test at screening within 1 week before treatment.
• • 7. The patient (male and female) agrees to use two acceptable contraceptive methods for the duration of time on the study and continue to use acceptable contraceptive methods for 6 months after the end of treatment
• • 8. The patient has signed informed consent before initiation of any study-specific procedures or treatment.
• • 9. The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment
• Exclusion Criteria:
• • 1. Patient was diagnosed as acute promyelocytic leukemia.
• • 2. Patient has BCR-ABL-positive leukemia or chronic myelogenous leukemia in blast crisis.
• • 3. Patient has clinically active central nervous system leukemia.
• • 4. Patient has been diagnosed with another malignancy, unless disease-free for at least 3 years. Subjects with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, papillary thyroid carcinoma, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Subjects with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy.
• • 5. Patient has had major surgery within 4 weeks prior to the first study dose.
• • 6. Patient has radiation therapy within 4 weeks prior to the first study dose.
• • 7. Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 1 month prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.
• • 8. Patient has an active uncontrolled infection.
• • 9. Patient has active human immunodeficiency virus infection.
• • 10. Patient has active hepatitis B or C or other active hepatic disorder. Chronic conditions previously cured or in active prophylaxis are allowed in the study
• • 11. Patient has infections, comorbidities or any disease, condition or alteration that per judgment of the investigator may be jeopardized by therapy
• • 12. Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy with the exception of Hydroxyurea (HU) or 6-Mercaptopurine (6MP) in patients who need to continue this agent to maintain WBC count ≤10,000/mm3. HU and 6MP must be discontinued at the time of initiation of study medications.