Clinical Trial Details

NCT ID: NCT02927262
Date Last Changed: October 16, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of ASP2215 and Placebo to evaluate Acute Myeloid Leukemia (AML) or Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation

Research Study Title

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FLT3/ITD AML in First Complete Remission

Purpose

The purpose of this study is to compare relapse-free survival (RFS) between subjects with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who are randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a two-year period.

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Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Astellas Pharma Global Development, Inc.
Duration
86 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • Subject is considered an adult according to local regulation at the time of obtaining consent form (ICF).

  • Subject consents to allow access to subject's diagnostic bone marrow aspirate or peripheral blood sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic test that is being developed in parallel with gilteritinib.

  • Subject has confirmed morphologically documented AML, excluding acute promyelocytic leukemia (APL), in CR1 (including CRp and CRi). For the purposes of enrollment, CR will be defined as < 5% blasts in the bone marrow with no morphologic characteristics of acute leukemia (e.g., Auer rods) in the bone marrow with no evidence of extramedullary disease such as central nervous system involvement or granulocytic sarcoma.

  • Subject will not proceed with transplantation as either a decision not to proceed with transplantation has been made either on the recommendation of the treating physician or by the patient or a suitable donor could not be identified.

  • Subject is < 2 months from the start of the last cycle of consolidation and should have completed the recommended number of consolidations per local practice.

  • Subject has had no use of investigational agents, with the exception of FLT3 inhibiting agents during induction and/or consolidation therapy, within the prior 4 weeks.

  • Subject has had presence of the FLT3/ITD activating mutation in the bone marrow or peripheral blood as determined by the local institution at diagnosis.

  • Subject has an ECOG performance status 0 to 2.

  • Subject must meet the following criteria as indicated on the clinical laboratory tests:

  • Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN), or if serum creatinine outside normal range, then glomerular filtration rate (GFR) > 40 mL/min/1.73m^2 as calculated with the 4-parameter Modification of Diet in Renal Disease (MDRD) equation.

  • Serum total bilirubin ≤ 2.5 mg/dL (43 μmol/L), except for subjects with Gilbert's syndrome.

  • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN.

  • Serum potassium and serum magnesium ≥ institutional lower limit of normal (LLN).

  • Absolute neutrophil count (ANC) ≥ 500/μl and platelets ≥ 20000/μl (unsupported by transfusions).

  • Subject is suitable for oral administration of study drug.

  • Female subject must either:

  • Be of nonchildbearing potential:

  • Postmenopausal (defined as at least 1 year without any menses) prior to screening, or

  • Documented surgically sterile or status posthysterectomy (at least 1 month prior to screening)

  • Or, if of childbearing potential,

  • Agree not to try to become pregnant during the study and for 6 months after the final study drug administration

  • And have a negative urine or serum pregnancy test at screening

  • And, if heterosexually active, agree to consistently use highly effective contraception per locally accepted standards (in addition to a barrier method) starting at screening and throughout the study period and for 6 months after the final study drug administration.

  • Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 2 months and 1 week after the final study drug administration.

  • Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.

  • Male subject and subject's female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards (in addition to a barrier method) starting at screening and continue throughout the study period and for 4 months and 1 week after the final study drug administration.

  • Male subject must not donate sperm starting at screening and throughout the study period and for 4 months and 1 week after the final study drug administration.

  • Subject agrees not to participate in another interventional study while on treatment.

Exclusion Criteria:

  • Subject has had prior allogeneic transplant.

  • Subject has QTcF interval > 450 msec (average of triplicate determinations based on central reading).

  • Subject with Long QT Syndrome.

  • Subject with hypokalemia and hypomagnesemia at screening (defined as values below LLN).

  • Subject has clinically active central nervous system leukemia.

  • Subject is known to have human immunodeficiency virus infection.

  • Subject has active hepatitis B or C.

  • Subject has an uncontrolled infection. If a bacterial or viral infection is present, the subject must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to randomization. If a fungal infection is present, the subject must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to randomization.

  • Subject has progressing infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.

  • Subject has uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subject has a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 1 month prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.

  • Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP) 3A.

  • Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.

  • Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.

  • Subject has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.

  • Subject has prior malignancies, except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed.

  • Subject has any condition which makes the subject unsuitable for study participation.

Site Locations (140)

Country State City Zip Facility and Contact
United States California Los Angeles 90003 Site US10013
United States California Whittier 90603 Site US10023
United States Florida Gainesville 32610-0278 Site US10017
United States Florida Jacksonville 32204 Site US10030
United States Georgia Augusta 30912 Site US10019
United States Illinois Chicago 60612 Site US10012
United States Kentucky Louisville 40207 Site US10015
United States Massachusetts Boston 02111 Site US10026
United States Michigan Detroit 48202 Site US10004
United States New York Hawthorne 10532 Site US10024
United States New York New York 10016 Site US10018
United States New York New York 10021 Site US10028
United States New York Syracuse 13210 Site US10025
United States North Carolina Durham 27705 Site US10002
United States Ohio Canton 44718 Site US10022
United States Oregon Portland 97239 Site US10007
United States South Carolina Charleston 29425 Site US10020
United States South Carolina Greenville 26615 Site US10029
United States Virginia Fairfax 22031 Site US10009
United States Washington Seattle 98104 Site US10031
Australia New South Wales Liverpool 2170 Site AU61006
Australia Queensland Southport 4215 Site AU61002
Australia Victoria Geelong 3220 Site AU61005
Canada Nova Scotia Halifax B3H2Y9 Site CA15001
Canada Ontario Toronto M5G 2M9 Site CA15003
Canada Quebec Montreal H4A 3J1 Site CA15005
Canada Saskatchewan Regina S4T 7T1 Site CA15004
Chile Araucania Temuco 4810469 Site CL56002
Croatia Grad Zagreb Zagreb 10000 Site HR38501
Croatia Grad Zagreb Zagreb 10000 Site HR38502
Denmark Region Midtjylland Arhus DK 8000 Site DK45002
Denmark Region Syddanmark Odense 5000 Site DK45003
France Bouches-du-Rhone Aix-en-Provence cedex 13616 Site FR33016
France Finistere Brest 29609 Site FR33004
France Haute-Garonne Toulouse Cedex 9 31059 Site FR33003
France Indre-et-Loire Tours cedex 01 37044 Site FR33002
France Languedoc-Roussillon Perpignan 66046 Site FR33010
France Meurthe-et-Moselle Vandoeuvre les Nancy 54511 Site FR33014
France Provence-Alpes-Cote-d'Azur Avignon 84902 Site FR33017
France Rhone Pierre-Benite 69310 Site FR33007
France Seine-et-Marne Meaux 77100 Site FR33006
France Val-d'Oise Argenteuil 95107 Site FR33018
France Bayonne 64100 Site FR33001
France Mulhouse 68070 Site FR33009
France Nice Cedex 2 06189 Site FR33008
France Strasbourg 67000 Site FR33013
Germany Mecklenburg-Vorpommern Rostock 18057 Site DE49009
Germany Nordrhein-Westfalen Duisburg 47166 Site DE49001
Germany Greifswald 17475 Site DE49005
Germany Stuttgart 70376 Site DE49008
Greece Attiki Athens 10676 Site GR30010
Greece Attiki Athens 11527 Site GR30003
Greece Evros Alexandroupolis 68100 Site GR30002
Greece Kentriki Makedonia Thessaloniki 57010 Site GR30004
Greece Athens 11527 Site GR30011
Hungary Csongrad Szeged H-6725 Site HU36006
Hungary Szabolcs-Szatmar-Bereg Nyiregyhaza H-4400 Site HU36003
Hungary Budapest H 1083 Site HU36001
Hungary Debrecen H-4032 Site HU36004
Hungary Pecs H-7624 Site HU36007
Italy Treviso Castelfranco Veneto (TV) 31033 Site IT39004
Italy Venezia Mirano 30035 Site IT39007
Italy Bergamo 24127 Site IT39008
Italy Catania 95124 Site IT39009
Japan Aiti Nagoya 453-8511 Site JP81018
Japan Ehime Matsuyama 790-0024 Site JP81025
Japan Gunma Maebashi 371-0821 Site JP81007
Japan Hokkaido Sapporo 003-0006 Site JP81024
Japan Hokkaido Sapporo 060-8648 Site JP81022
Japan Hyogo Kobe 650-0047 Site JP81012
Japan Isikawa Kanazawa 920-8530 Site JP81004
Japan Kanagawa Isehara 259-1193 Site JP81003
Japan Kanagawa Yokohama 232-0024 Site JP81009
Japan Miyagi Sendai-shi 983 8520 Site JP81014
Japan Okayama Kurashiki 710-8602 Site JP81013
Japan Tiba Narita 286-8523 Site JP81005
Japan Tokyo Shinagawa-ku 141-8625 Site JP81008
Japan Tokyo Tachikawa 190-0014 Site JP81011
Japan Akita 010-8543 Site JP81021
Japan Aomori-city 030-8553 Site JP81010
Japan Fukui 910-1193 Site JP81002
Japan Fukuoka 812-8582 Site JP81020
Japan Kyoto 602 8566 Site JP81015
Japan Nagano 380-8582 Site JP81001
Japan Nagasaki 8528102 Site JP81016
Japan Nagoya 460-0001 Site JP81006
Japan Okayama 7008558 Site JP81017
Japan Osaka 565-0871 Site JP81019
Japan Shimotsuke 323-0112 Site JP81023
Korea, Republic of Gyeonggi-do Suwon-si 16499 Site KR82005
Korea, Republic of Gyeonggido Bucheon-Si 14584 Site KR82014
Korea, Republic of Gyeonggido Goyang 10408 Site KR82013
Korea, Republic of Incheon Gwang'yeogsiv Namdong 405 760 Site KR82008
Korea, Republic of Jeonranamdo Hwasungun 58128 Site KR82003
Korea, Republic of Seoul Teugbyeolsi Seoul 06351 Site KR82012
Korea, Republic of Seoul Teugbyeolsi Seoul 110-744 Site KR82007
Korea, Republic of Busan 49241 Site KR82006
Korea, Republic of Seoul 05505 Site KR82004
Korea, Republic of Seoul 06591 Site KR82002
Korea, Republic of Seoul 120-752 Site KR82009
Korea, Republic of Ulsan 44033 Site KR82001
Poland Mazowieckie Warszawa 02-106 Site PL48003
Poland Warmińsko-mazurskie Olsztyn 10-228 Site PL48001
Poland Bydgoszcz 85-168 Site PL48002
Portugal Coimbra 3000 Site PT35106
Portugal Lisboa 1169-050 Site PT35103
Portugal Porto 4200-072 Site PT35101
Serbia Belgrade 11000 Site RS38101
Serbia Belgrade 11000 Site RS38102
Spain Alava Vitoria 01009 Site ES34009
Spain Barcelona L'Hospitalet de Llobregat 08907 Site ES34001
Spain Navarra Pamplona 31008 Site ES34010
Spain Girona 17007 Site ES34003
Spain Madrid 28040 Site ES34008
Spain Madrid 28050 Site ES34002
Spain Sevilla 41014 Site ES34012
Spain Valladolid 47005 Site ES34006
Sweden Ostergotlands lan Linkoeping 581 85 Site SE46001
Sweden Stockholms lan Stockholm 171 76 Site SE46003
Sweden Lund 221 85 Site SE46002
Taiwan Taoyuan Kweishan Hsiang 33305 Site TW88601
Taiwan Kaohsiung 112 Site TW88605
Taiwan Kaohsiung 83301 Site TW88604
Taiwan Taichung 40705 Site TW88606
Taiwan Taipei 10449 Site TW88602
Taiwan Taipei 114 Site TW88603
Turkey Ankara 06500 Site TR90006
Turkey Aydin 09100 Site TR90011
Turkey Denizli 20070 Site TR90005
Turkey Istanbul 34093 Site TR90002
Turkey Izmir 35340 Site TR90003
Turkey Kayseri 38039 Site TR90001
Turkey Samsun 55139 Site TR90007
United Kingdom Devon Plymouth PL6 8DH Site GB44019
United Kingdom East Riding of Yorkshire Cottingham HU165JQ Site GB44006
United Kingdom London, City of London WC1E 6BT Site GB44018
United Kingdom Birmingham B95SS Site GB44002
United Kingdom Bristol BS2 8ED Site GB44005
United Kingdom Cardiff CF4 4XN Site GB44015
United Kingdom Leeds LS9 7TF Site GB44020

Contact

Astellas Pharma Global Development
800-888-7704 ext. 5473
E-mail:

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