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)
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|ClinicalTrials.gov Identifier: NCT03409081|
Expanded Access Status : No longer available
First Posted : January 24, 2018
Last Update Posted : September 13, 2018
|Condition or disease||Intervention/treatment|
|Acute Myeloid Leukemia (AML) FMS-like Tyrosine Kinase-3 (FLT3) Mutations||Drug: gilteritinib|
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 Type :||Expanded Access|
|Expanded Access Type :||Treatment IND/Protocol|
|Official Title:||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)|
- Drug: gilteritinib
oralOther Name: ASP2215
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409081
|Birmingham, United Kingdom|
|Bristol, United Kingdom|
|London, United Kingdom|
|Study Director:||Study Director||Astellas Pharma Global Development, Inc.|