ASH News Daily 2017 - Issue 1 - B-31

COME TO BOOTH 2007 TO LEARN MORE ABOUT GILTERITINIB CLINICAL TRIALS

Gilteritinib (ASP2215), as Maintenance Therapy in
FLT3/ITD+ AML Patients in First Complete Remission

EN N
RO OW
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2215-CL- 0302 / NCT02927262

DESCRIPTION
A Phase 3 double-blind, multicenter, randomized, placebo-controlled study of gilteritinib (ASP2215) as maintenance therapy following induction/consolidation
therapy in AML patients with FLT3/ITD in first complete remission

STATUS: NOW ENROLLING
Gilteritinib
Continuous dosing
for up to 2 years
AML with
FLT3/ITD
mutation
Morphological
CR1

double-blind
randomization
2:1

Follow-up

Placebo
Continuous dosing
for up to 2 years

PRIMARY ENDPOINT

SELECTION CRITERIAb

* Relapse-free survival

* Morphologically confirmed AML in first complete
remission

SECONDARY ENDPOINTSa

* Positive for FLT3/ITD mutation

* Overall survival

* Patients who will not proceed with transplantation

* Event-free survival

* Patient is < 2 months from the start of last cycle of
consolidation therapy

* Minimal residual disease

AML = acute myeloid leukemia; CR1 = first complete remission;
FLT3 = FMS-like tyrosine kinase 3; ITD = internal tandem duplication.

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 the agent will receive regulatory approval and become
commercially available for uses being investigated. All information current as of October 2017.
a
Not all secondary endpoints listed. bNot a complete list of selection criteria.
For more information, email Astellas.registration@astellas.com, or visit https://clinicaltrials.gov/ct2/show/NCT02927262. ClinicalTrials.gov. A Phase 3 Multicenter, Randomized,
Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as MaintenanceTherapy Following Induction/Consolidation Therapy for Subjects
With FLT3/ITD AML in First Complete Remission (06-26-2017). https://clinicaltrials.gov/ct2/show/NCT02927262?term=NCT02927262&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. 077-0029-PM 10/17

Gilteritinib (ASP2215), as Maintenance Therapy in
FLT3/ITD+ AML Patients Following Allogeneic Transplant
2215-CL-0304/NCT02997202

DESCRIPTION
A multi-center, randomized, double-blind, placebo-controlled phase 3 trial of the FLT3 Inhibitor gilteritinib administered as maintenance therapy following allogeneic
transplant for patients with FLT3/ITD AML

STATUS: NOW ENROLLING
Gilteritinib
continuous dosing
for 24 months

AML with
FLT3/ITD mutation
Morphological
CR1

SECONDARY ENDPOINTS

double-blind
randomization
1:1

Follow-up

HSCT

AML = acute myeloid leukemia; CR1 = first complete remission;
FLT3 = FMS-like tyrosine kinase 3; ITD = internal tandem duplication;
HSCT = hematopioetic stem cell transplant

Placebo
continuous dosing
for 24 months

PRIMARY ENDPOINT
* Relapse-free survival

* Safety and tolerability compared with placebo
* Overall survival compared with placebo
* Non-relapse mortality compared with placebo
* Event-free survival at 12 and 24 months
compared with placebo
* Cumulative incidence of Acute Graft vs
Host Disease (aGvHD)
* Cumulative incidence of Chronic GVHD at
12 and 24 months
* Cumulative incidence of detection of
FLT3/ITD MRD

KEY REGISTRATION CRITERIAa

* In CR after 1 or 2 cycles of induction therapy
* Candidate for HSCT
* Presence of FLT3/ITD activating mutations

KEY RANDOMIZATION CRITERIAa

* Patients within 30 - 90 day post-transplant
* In continuous CR after transplant

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 the agent will receive regulatory approval and become
commercially available for uses being investigated. All information current as of October 2017.
CR = complete remission; FLT3 = FMS-like tyrosine kinase 3; ITD = internal tandem duplication; HSCT = hematopoetic stem cell transplant, MRD = minimal residual disease
a
Not a complete list of criteria
For more information, email Astellas.registration@astellas.com, or visit https://clinicaltrials.gov/ct2/show/NCT02997202.
ClinicalTrials.gov. A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following
Allogeneic Transplant for Patients With FLT3/ITD AML (07-18-2017). https://clinicaltrials.gov/ct2/show/NCT02997202?term=NCT02997202&rank=1. Accessed 07-26-2017.
In partnership with the Blood and Marrow Transplant Clinical Trials Network, a National Heart, Lung, and Blood Institute and National Cancer Institute supported network.
Astellas® and the flying star logo are trademarks of Astellas Pharma Inc.
©2017 Astellas Pharma Global Development, Inc. All rights reserved. 077-0029-PM 10/17

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Table of Contents for the Digital Edition of ASH News Daily 2017 - Issue 1