ASH News Daily 2017 - Issue 1 - C-15
COME TO BOOTH 2007 TO LEARN MORE ABOUT GILTERITINIB CLINICAL TRIALS
EN N
RO OW
LL
IN
G
Gilteritinib (ASP2215), Gilteritinib + Azacitidine, or Azacitidine in
Newly Diagnosed FLT3+ AML Patients Not Eligible for Intensive
Induction Chemotherapy
2215-CL-0201 / NCT02752035
DESCRIPTION
A phase 2/3, open-label, multicenter, randomized study of gilteritinib (ASP2215) monotherapy, combination gilteritinib plus azacitidine, and
azacitidine monotherapy in newly diagnosed AML patients with FLT3 mutations that are not eligible for intensive induction chemotherapy
STATUS: NOW ENROLLING
Newly diagnosed
AML/FLT3mut
not eligible for
high-intensity
chemotherapy
(N = 540)
R
1:1:1
Safety cohort: Prior to initiation of the randomized trial, 8 to 12 subjects
will be enrolled to evaluate the safety and tolerability of gilteritinib given with
azacitidine therapy in the study population
Interim futility analysis: Interim futility analysis is planned, after approximately
50 subjects in each arm have either discontinued treatment or completed 2 cycles
of treatment. The trial will either continue as planned, one treatment arm with
ASP2215 may be discontinued, or the trial will be stopped
AML = acute myeloid leukemia;
FLT3 = FMS-like tyrosine kinase 3;
R = randomized
Gilteritinib
monotherapy
until lack of
clinical benefit or
unacceptable
toxicity
Follow-up
Gilteritinib +
Azacitidine
until lack of
clinical benefit or
unacceptable
toxicity
Follow-up
Azacitidine
(Control)
until lack of
clinical benefit or
unacceptable
toxicity
Follow-up
Gilteritinib will be administered in continuous 28-day cycles.
Azacitidine will be administered daily for the first 7 days of each 28-day cycle.
PRIMARY ENDPOINT
* Overall survival
SECONDARY ENDPOINTSa
* Event-free survival
* Best response
* Leukemia free survival
* Duration of remission
* Participant reported fatigue from Brief Fatigue Inventory
SELECTION CRITERIAb
* Diagnosis of previously-untreated AML
* Ineligible for intensive induction chemotherapy
* Positive for FLT3 mutation
CONTACT
Astellas Pharma Global Development | 800-888-7704, ext 5473 | Astellas.registration@astellas.com
The safety and efficacy of the agent under investigation have not been established. There is no guarantee that gilteritinib or gilteritinib in
combination with azacitidine will receive regulatory approval and become commercially available for uses being investigated.
All information current as of October 2017.
Not a complete list of endpoints.
Not a complete list of selection criteria.
a
b
For more information, email Astellas.registration@astellas.com, or visit https://clinicaltrials.gov/ct2/show/NCT02752035
ClinicalTrials.gov. A Phase 2/3 Multicenter, Open-label, 3-arm, 2-Stage Randomized Study of ASP2215 (Gilteritinib),
Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy (05-23-2017).https://clinicaltrials.gov/
ct2/show/NCT02752035?term=NCT02752035&rank=1. Accessed 07-27-2017.
Astellas® and the flying star logo are trademarks of Astellas Pharma Inc.
©2017 Astellas Pharma Global Development, Inc. All rights reserved. 077-0028-PM 10/17
ONCOLOGY
Changing Tomorrow in Cancer Care
150103659 ASH2017NewsDailyAds_TrialLacewing_L1e.indd 1
10/16/17 2:16 PM
Table of Contents for the Digital Edition of ASH News Daily 2017 - Issue 1
ASH News Daily 2017 - Issue 1 - A-1
ASH News Daily 2017 - Issue 1 - A-2
ASH News Daily 2017 - Issue 1 - A-3
ASH News Daily 2017 - Issue 1 - A-4
ASH News Daily 2017 - Issue 1 - A-5
ASH News Daily 2017 - Issue 1 - A-6
ASH News Daily 2017 - Issue 1 - A-7
ASH News Daily 2017 - Issue 1 - A-8
ASH News Daily 2017 - Issue 1 - A-9
ASH News Daily 2017 - Issue 1 - A-10
ASH News Daily 2017 - Issue 1 - A-11
ASH News Daily 2017 - Issue 1 - A-12
ASH News Daily 2017 - Issue 1 - A-13
ASH News Daily 2017 - Issue 1 - A-14
ASH News Daily 2017 - Issue 1 - A-15
ASH News Daily 2017 - Issue 1 - A-16
ASH News Daily 2017 - Issue 1 - A-17
ASH News Daily 2017 - Issue 1 - A-18
ASH News Daily 2017 - Issue 1 - A-19
ASH News Daily 2017 - Issue 1 - A-20
ASH News Daily 2017 - Issue 1 - A-21
ASH News Daily 2017 - Issue 1 - A-22
ASH News Daily 2017 - Issue 1 - A-23
ASH News Daily 2017 - Issue 1 - A-24
ASH News Daily 2017 - Issue 1 - A-25
ASH News Daily 2017 - Issue 1 - A-26
ASH News Daily 2017 - Issue 1 - A-27
ASH News Daily 2017 - Issue 1 - A-28
ASH News Daily 2017 - Issue 1 - B-1
ASH News Daily 2017 - Issue 1 - B-2
ASH News Daily 2017 - Issue 1 - B-3
ASH News Daily 2017 - Issue 1 - B-4
ASH News Daily 2017 - Issue 1 - B-5
ASH News Daily 2017 - Issue 1 - B-6
ASH News Daily 2017 - Issue 1 - B-7
ASH News Daily 2017 - Issue 1 - B-8
ASH News Daily 2017 - Issue 1 - B-9
ASH News Daily 2017 - Issue 1 - B-10
ASH News Daily 2017 - Issue 1 - B-11
ASH News Daily 2017 - Issue 1 - B-12
ASH News Daily 2017 - Issue 1 - B-13
ASH News Daily 2017 - Issue 1 - B-14
ASH News Daily 2017 - Issue 1 - B-15
ASH News Daily 2017 - Issue 1 - B-16
ASH News Daily 2017 - Issue 1 - B-17
ASH News Daily 2017 - Issue 1 - B-18
ASH News Daily 2017 - Issue 1 - B-19
ASH News Daily 2017 - Issue 1 - B-20
ASH News Daily 2017 - Issue 1 - B-21
ASH News Daily 2017 - Issue 1 - B-22
ASH News Daily 2017 - Issue 1 - B-23
ASH News Daily 2017 - Issue 1 - B-24
ASH News Daily 2017 - Issue 1 - B-25
ASH News Daily 2017 - Issue 1 - B-26
ASH News Daily 2017 - Issue 1 - B-27
ASH News Daily 2017 - Issue 1 - B-30
ASH News Daily 2017 - Issue 1 - B-31
ASH News Daily 2017 - Issue 1 - B-32
ASH News Daily 2017 - Issue 1 - B-33
ASH News Daily 2017 - Issue 1 - B-34
ASH News Daily 2017 - Issue 1 - B-35
ASH News Daily 2017 - Issue 1 - B-36
ASH News Daily 2017 - Issue 1 - B-37
ASH News Daily 2017 - Issue 1 - B-38
ASH News Daily 2017 - Issue 1 - B-39
ASH News Daily 2017 - Issue 1 - B-40
ASH News Daily 2017 - Issue 1 - B-41
ASH News Daily 2017 - Issue 1 - B-42
ASH News Daily 2017 - Issue 1 - B-43
ASH News Daily 2017 - Issue 1 - B-44
ASH News Daily 2017 - Issue 1 - B-45
ASH News Daily 2017 - Issue 1 - B-46
ASH News Daily 2017 - Issue 1 - B-47
ASH News Daily 2017 - Issue 1 - B-48
ASH News Daily 2017 - Issue 1 - B-49
ASH News Daily 2017 - Issue 1 - B-50
ASH News Daily 2017 - Issue 1 - B-51
ASH News Daily 2017 - Issue 1 - B-52
ASH News Daily 2017 - Issue 1 - B-53
ASH News Daily 2017 - Issue 1 - B-54
ASH News Daily 2017 - Issue 1 - B-55
ASH News Daily 2017 - Issue 1 - B-56
ASH News Daily 2017 - Issue 1 - C-1
ASH News Daily 2017 - Issue 1 - C-2
ASH News Daily 2017 - Issue 1 - C-3
ASH News Daily 2017 - Issue 1 - C-4
ASH News Daily 2017 - Issue 1 - C-5
ASH News Daily 2017 - Issue 1 - C-6
ASH News Daily 2017 - Issue 1 - C-7
ASH News Daily 2017 - Issue 1 - C-8
ASH News Daily 2017 - Issue 1 - C-9
ASH News Daily 2017 - Issue 1 - C-10
ASH News Daily 2017 - Issue 1 - C-11
ASH News Daily 2017 - Issue 1 - C-12
ASH News Daily 2017 - Issue 1 - C-13
ASH News Daily 2017 - Issue 1 - C-14
ASH News Daily 2017 - Issue 1 - C-15
ASH News Daily 2017 - Issue 1 - C-16
ASH News Daily 2017 - Issue 1 - C-17
ASH News Daily 2017 - Issue 1 - C-18
ASH News Daily 2017 - Issue 1 - C-19
ASH News Daily 2017 - Issue 1 - C-20
ASH News Daily 2017 - Issue 1 - C-21
ASH News Daily 2017 - Issue 1 - C-22
ASH News Daily 2017 - Issue 1 - C-23
ASH News Daily 2017 - Issue 1 - C-24
ASH News Daily 2017 - Issue 1 - C-25
ASH News Daily 2017 - Issue 1 - C-26
ASH News Daily 2017 - Issue 1 - C-27
ASH News Daily 2017 - Issue 1 - C-28
ASH News Daily 2017 - Issue 1 - C-29
ASH News Daily 2017 - Issue 1 - C-30
ASH News Daily 2017 - Issue 1 - C-31
ASH News Daily 2017 - Issue 1 - C-32
https://www.nxtbookmedia.com