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 mutation.
- 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 leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-002301-61-IT
- Lead Sponsor
- ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 114
1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent and privacy language as required per national regulations (e.g., Health Insurance Portability and Accountability Act Authorization for US sites) must be obtained from the subject or subject's parent or legal guardian and if required child assent prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
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.
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).
5. Subject has Karnofsky score >= 50 (if the subject is of >= 16 years of age) or Lansky score of >= 50 (if the subject is < 16 years of age).
Are the trial subjects under 18? yes
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 34
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Subject has active CNS leukemia.
2. Subject has uncontrolled or significant cardiovascular disease
3. Subject has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The subject needs to be off pressors and have negative blood cultures for 48 hours.
5. Subject is receiving or plans to receive concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
6. Subject has active clinically significant GVHD or is on treatment with systemic corticosteroids and is receiving > 0.5 mg/kg of prednisone (or equivalent) daily dose for GVHD.
7. Subject has active malignant tumors other than AML.
8. 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.
9. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
10. Subject must wait for at least 5 half-lives after stopping therapy with any investigational agent and before starting gilteritinib.
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