The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation
Official Title: Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation
Study ID: NCT03182244
Brief Summary: The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study will evaluate safety as well as determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
Detailed Description: Participants considered an adult according to local regulations at the time of signing informed consent will be randomized in a 1:1 ratio to receive ASP2215 or salvage chemotherapy. Participants will enter the screening period up to 14 days prior to the start of treatment. Prior to randomization, the investigator will preselect a salvage chemotherapy regimen for each participant; options will include low-dose cytarabine (LoDAC), mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) or fludarabine, high-dose cytarabine and granulocyte colony-stimulating factor (FLAG). The randomization will be stratified by response to first-line therapy and preselected salvage chemotherapy. Participants will be administered treatment over continuous 28-day cycles. Among the participants, approximately 20 Chinese participants who are randomized into the ASP2215 arm will be allocated to the pharmacokinetic (PK) cohort. Participants in the PK cohort will be requested to be hospitalized from the date of randomization (Day 1) to at least the completion of all the assessments planned on Day 2. All participants in the PK cohort will undergo blood sampling for PK measurement of ASP2215. Participants in PK cohort will be administered the study drug in the same manner and undergo the same efficacy and safety assessments as other participants except for blood sampling for additional PK measurements.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Site CN103, Beijing, , China
Site CN108, Beijing, , China
Site CN109, Beijing, , China
Site CN110, Beijing, , China
Site CN131, Beijing, , China
Site CN116, Changchun, , China
Site CN120, Changsha, , China
Site CN119, Fuzhou, , China
Site CN102, Guangzhou, , China
Site CN114, Guangzhou, , China
Site CN121, Guangzhou, , China
Site CN130, Guiyang City, , China
Site CN107, Hangzhou, , China
Site CN118, Hefei, , China
Site CN123, Huangpu Qu, , China
Site CN117, Jinan, , China
Site CN133, Lanzhou, , China
Site CN128, Nanjing, , China
Site CN106, Qingdao, , China
Site CN126, Shanghai, , China
Site CN129, Shanghai, , China
Site CN125, Shenyang, , China
Site CN101, Tianjin, , China
Site CN105, Wuhan, , China
Site CN122, Xi'an, , China
Site CN132, Zhangzhou, , China
Site CN113, Zhengzhou, , China
Site CN136, Zhengzhou, , China
Site MY306, Ampang, , Malaysia
Site MY305, George Town, , Malaysia
Site MY301, Johor Bahru, , Malaysia
Site MY304, Kota Kinabalu, , Malaysia
Site MY302, Kuala Lumpur, , Malaysia
Site MY303, Pulau Pinang, , Malaysia
Site RU506, Kemerovo, , Russian Federation
Site RU504, Krasnoyarsk, , Russian Federation
Site RU508, Moscow, , Russian Federation
Site RU509, Moscow, , Russian Federation
Site RU501, Saint Petersburg, , Russian Federation
Site RU507, Saint Petersburg, , Russian Federation
Site RU502, Saint-Petersburg, , Russian Federation
Site SG401, Singapore, , Singapore
Site SG402, Singapore, , Singapore
Site SG403, Singapore, , Singapore
Site TH203, Bangkok, , Thailand
Site TH205, Bangkok, , Thailand
Site TH204, Chiang Mai, , Thailand
Site TH201, Khon Kaen, , Thailand
Site TH202, Khon Kaen, , Thailand
Name: Medical Director
Affiliation: Astellas Pharma Inc
Role: STUDY_DIRECTOR