A study of Gilteritinib combined with chemotherapy to treat Children, Adolescents and Young Adults with Relapsed or Refractory Acute Myeloid Leukemia (AML) with a FLT3 gene mutatio
- Conditions
- FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD)Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)MedDRA version: 21.0Level: LLTClassification code: 10000886Term: Acute myeloid leukemia Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-512469-15-00
- Lead Sponsor
- Astellas Pharma Global Development Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 97
2. Phase 1: Subject is positive for FLT3 (ITD and/or TKD) mutation in bone marrow or blood as determined by the local institution. Phase 2: Subject is positive for the FLT3 (ITD) mutation in bone marrow or blood as determined by the local institution., 3. Subject is aged = 6 months and < 21 years of age* at the time of signing informed consent and/or assent, as applicable. * For phase 2: Enrollment of subjects from 6 months to less than 1 year (Group 3) and 1 year to less than 2 years (Group 2) will be dependent on the establishment of RP2D in the respective for age groups during phase 1., 4. Subject has a diagnosis of AML according to The French–American–British (FAB) classification with = 5% blasts in the bone marrow, with or without extramedullary disease (except subjects with active central nervous system (CNS) Leukemia). a) In the phase 1 portion of the study, subject must be in first or greater relapse or refractory to induction therapy with no more than 1 attempt at remission induction (up to 2 induction cycles). b) For the phase 2 portion of the study, subject must be refractory to or at the first hematologic relapse after first-line remission induction AML therapy (up to 2 induction cycles)
1. Subject has active central nervous system (CNS) leukemia., 3. Subject has uncontrolled or significant cardiovascular disease, including: • Diagnosed or suspected congenital long QT syndrome or any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); any history of arrhythmia will be discussed with the sponsor’s medical monitor prior to subject’s entry into the study • Prolonged Fridericia-corrected QT interval (QTcF) interval on pre-entry electrocardiogram (ECG) (= 450 ms) • Any history of second- or third-degree heart block (may be eligible if the subject currently has a pacemaker) • Heart rate < 50 beats/minute on pre-entry ECG • Uncontrolled hypertension • Complete left bundle branch block, 6. Subject has active clinically significant graft-versus-host disease (GVHD) or is on treatment with immunosuppressive drugs for treatment of active GVHD, with the exception of subjects being weaned from systemic corticosteroids where the subject is receiving = 0.5 mg/kg of prednisone (or equivalent) daily dose for prior GVHD. Subject has received calcineurin inhibitors within 4 weeks prior to screening, unless used as GVHD prophylaxis, 7. Subject has active malignant tumors other than AML., 9. Subject has hypokalemia and/or hypomagnesemia at Screening (defined as values below institutional lower limit of normal [LLN]). Repletion of potassium and magnesium levels during the screening period is allowed., 10. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A/P-glycoprotein (P-gp).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method