Effectiveness and safety of gilteritinib (ASP2215) as maintenance treatment (maintain the response achieved during the first course of treatment) for Acute myeloid leukemia patients who are in a first complete remission (no residual leukemia cells in your bone marrow), with mutations in the FLT3 gene compared to placebo given alone.

Phase 1

• Conditions: Subjects diagnosed with FLT3/ITD acute myeloid leukemia (AML) in CR1, including CRp and CRi, for whom a decision not to proceed with transplantation has been made, or a suitable donor could not be identified.; MedDRA version: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001643-39-FR
• Lead Sponsor: Astellas Pharma Global Development, Inc. (APGD)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-12
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1. Written informed consent must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
2. Subject is considered an adult according to local regulation at the time of signing informed consent form (ICF).
3. Subject consents to allow access to his or her diagnostic bone marrow aspirate or peripheral blood sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic test that is being developed in parallel with gilteritinib.
4. Subject has confirmed morphologically documented AML in CR1 (including CRp and CRi). For the purposes of enrollment, CR will be defined as < 5% blasts in the bone marrow with no morphologic characteristics of acute leukemia (e.g., Auer rods) in the bone marrow with no evidence of extramedullary disease such as central nervous system involvement or granulocytic sarcoma.
5. Subject will not proceed with transplantation as either a decision not to proceed with transplantation has been made either on the recommendation of the treating physician or by the patient or a suitable donor could not be identified.
6. Subject is < 2 months from the start of the last cycle of consolidation and should have completed the recommended number of consolidations per local practice.
7. Subject has had no use of investigational agents, with the exception of FLT3 inhibiting agents during induction and/or consolidation therapy, within the prior 4 weeks.
8. Subject has had presence of the FLT3/ITD activating mutation in the bone marrow or peripheral blood as determined by the local institution at diagnosis.
9. Subject has an ECOG performance status 0 to 2.
10. Subject must meet the following criteria as indicated on the clinical laboratory tests:
? Serum creatinine = 1.5 x institutional upper limit of normal (ULN), or if serum creatinine outside normal range, then glomerular filtration rate (GFR) > 40 mL/min/1.73m2 as calculated with the 4-parameter Modification of Diet in Renal Disease (MDRD) equation.
? Serum total bilirubin = 2.5 mg/dL, except for subjects with Gilbert’s syndrome.
? Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN.
? Serum potassium and serum magnesium = institutional lower limit of normal (LLN).
? Absolute neutrophil count (ANC) = 500/µl and platelets = 20000/µl (unsupported by transfusions).
11. Subject is suitable for oral administration of study drug.

For Inclusion Criteria 12-17 see Protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

1.Subject has had prior allogeneic transplant.
2. Subject has QTcF interval > 450 msec (average of triplicate determinations).
3. Subject with Long QT Syndrome.
4. Subject with hypokalemia and hypomagnesemia at screening (defined as values below LLN).
5. Subject has clinically active central nervous system leukemia.
6. Subject is known to have human immunodeficiency virus infection.
7. Subject has active hepatitis B or C.
8. Subject has an uncontrolled infection. If a bacterial or viral infection is present, the subject must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to randomization. If a fungal infection is present, the subject must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to randomization.
9. Subject has progressing infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
10. Subject has uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subject has a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 1 month prior to study entry results in a left ventricular ejection fraction that is = 45%.
11. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP) 3A.
12. Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.
13. Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.

For Exclusion Criteria 14-16 see Protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified