NCT03409081
No Longer Available
Not Applicable
Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or With FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
Astellas Pharma Global Development, Inc.6 sites in 3 countriesStarted: January 24, 2018Last updated:
Overview
- Phase
- Not Applicable
- Status
- No Longer Available
- Locations
- 6
Overview
Brief Summary
The purpose of this study is to provide expanded access to gilteritinib (ASP2215) for patients with FMS-like tyrosine kinase 3 (FLT3)-mutated relapsed or refractory acute myeloid leukemia (AML) or with FLT3-mutated AML in composite complete remission (CRc: [complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission with incomplete platelet recovery (CRp)]) with minimal residual disease (MRD) without access to comparable or alternative therapy.
Detailed Description
This treatment protocol is being conducted while phase 3 gilteritinib (ASP2215) studies are ongoing in FLT3-mutated AML patients.
Patients will be administered treatment over 28-day cycles. Patients will complete visits on cycle 1 days 1, 4, 8, 15; cycle 2 days 1, 15; day 1 of cycles 3 through 6; and day 1 of every 2 cycles thereafter until discontinued from the program.
An end of treatment visit will be performed within 7 days after last dose of medicinal product (gilteritinib [ASP2215]), or prior to initiation of another anticancer therapy, whichever occurs earlier, followed by a 30-day follow-up.
Study Design
- Study Type
- Expanded Access
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is considered an adult according to local regulation at the time of signing informed consent.
- •Patient has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome or therapy-related AML according to World Health Organization (WHO) classification as determined by pathology review at the treating institution.
- •Patient has presence of the FLT3 mutation (internal tandem duplication and/or tyrosine kinase domain \[D835/I836\] mutation) in bone marrow or peripheral blood.
- •Patient has refractory or relapsed AML (with or without Hematopoietic stem cell transplant (HSCT)) or has AML in CRc (CR, CRi, CRp) with Minimal residual disease (MRD) by flow cytometry or genetic testing for the FLT3 mutation after induction/consolidation regimen or HSCT.
- •There is no comparable or satisfactory alternative therapy to treat the patient's AML.
- •Patient has not received any chemotherapy or investigational agent within at least 5 half-lives after stopping that drug and before starting gilteritinib (ASP2215).
- •Patient must meet the following criteria as indicated on clinical laboratory tests:
- •Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 institutional upper limit of normal
- •Serum total bilirubin ≤ 2.5 mg/dL, except for patients with Gilbert's syndrome
- •Serum potassium and serum magnesium ≥ institutional lower limit of normal.
Exclusion Criteria
- •Patient is able to participate in an ongoing clinical study of gilteritinib (ASP2215); or has previously participated in a randomized clinical study of gilteritinib (ASP2215) with a primary endpoint of survival that is not closed for efficacy.
- •Patient with Fridericia-corrected QT interval (QTcF) \> 450 ms at the screening visit based on local reading.
- •Patient with a known history of Long QT Syndrome at the screening visit.
- •Patient was diagnosed with acute promyelocytic leukemia (APL).
- •Patient has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
- •Patient has clinically significant coagulation abnormality unless secondary to AML.
- •Patient has active hepatitis B or C or an active hepatic disorder.
- •Patient has uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, or New York Heart Association Class IV heart failure.
- •Patient requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP) 3A.
- •Patient has any condition which makes the patient unsuitable for participation in the program.
Investigators
Study Sites (6)
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