Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
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|ClinicalTrials.gov Identifier: NCT03070093|
Expanded Access Status : Approved for marketing
First Posted : March 3, 2017
Last Update Posted : April 20, 2021
|Condition or disease||Intervention/treatment|
|Acute Myeloid Leukemia (AML) FMS-like Tyrosine Kinase-3 (FLT3) Mutations||Drug: gilteritinib|
The United States Food and Drug Administration (FDA), the Japanese Ministry of Health, Labour and Welfare (MHLW) and Health Canada have approved ASP2215/Gilteritinib (XOSPATA®) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.
This treatment protocol is being conducted while phase 3 ASP2215 studies are ongoing in FLT3-mutated AML subjects.
Subjects will complete visits on cycle 1 - days 1, 4, 8, 15; cycle 2 - days 1, 15; cycles 3 to 6 - day 1; and day 1 of every 2 cycles thereafter (i.e., cycle 8 day 1, cycle 10 day 1, etc.) until discontinued from the study.
Subjects will be provided with study medication until the investigator determines the subject is no longer receiving clinical benefit.
An end of treatment visit will be performed within 7 days after last dose of investigational product (ASP2215), or prior to initiation of another anticancer therapy, whichever occurs earlier, followed by a 30-day follow-up. [Specific to investigational sites in Japan: Study population does not include subjects with FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD. Hence, efficacy (MRD response rate and duration of response) data will not be collected for subjects enrolled in Japan.]
|Study Type :||Expanded Access|
|Expanded Access Type :||Treatment IND/Protocol|
|See clinical trials of the intervention/treatment in this expanded access record.|
|Official Title:||A Multicenter, Open-label Treatment Protocol of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or 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): NCT03070093
|Study Director:||Medical Director||Astellas Pharma Global Development, Inc.|