IDHENTIFY: An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation

• Sponsor: Celgene (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02577406
• Collaborator: (none)
• Enrollment: 319
• Locations: 146
• Arms: 2
• Anticipated Duration (Months): 84
• Patients Per Site: 2.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid; Isocitrate Dehydrogenase	Drug: AG-221; Other: BSC; Drug: Azacitidine; Drug: Low-dose cytarabine (LDAC); Drug: Intermediate-dose cytarabine (IDAC)	Phase 3

Detailed Description

Acute myeloid leukaemia (AML) is a form of cancer that is common in older patients. Mutations in the isocitrate dehydrogenase enzyme 2 (IDH2) have been found in approximately 15% of patients with AML.

The outcome of first line chemotherapy treatment is poor and many patients fail to attain complete remission (CR, ie refractory) or will eventually relapse. There is no single standard of care for relapsed or refractory AML. Since the prognosis is very poor there is a great need for new therapies.

Inhibition of the mutant IDH2 enzyme may represent a promising targeted therapy for AML. AG-221 is a small molecule inhibitor of the IDH2 enzyme, designed to preferentially target the mutant IDH2 variants. Data from the ongoing first-in-human study has shown AG-221 to be generally well tolerated and demonstrated CR in patients with IDH2 mutation positive relapsed or refractory AML.

The study purpose is to test the safety and efficacy of AG-221 compared with conventional care regimens (CCR), which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, in patients with late stage AML refractory to or relapsed after second or third line therapy and positive for the IDH2 mutation. Patients will be randomly assigned to receive open-label tablets of AG-221 or one of the CCR on continuous 28-day treatment cycles. The trial duration is expected to be 78 months which includes 42 months enrollment, approximately 7 months treatment and a follow-up period.

Study procedures include: vital signs, physical exams, ECGs, ECHO, urine/blood samples, bone marrow aspirates and/or biopsies and peripheral blood to test for IDH2 and assess treatment response. Bone marrow, blood, cheek swab samples will be used for genetic tests.

This study is being sponsored by Celgene Corporation. Approximately 316 participants will take part in the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 319 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation
• Actual Study Start Date: Dec 30, 2015
• Actual Primary Completion Date: Mar 17, 2020
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AG-221 plus Best supportive care (BSC) Continuous 28-day cycles of AG 221 100 mg orally (PO) once a day (QD) for 28 days, plus BSC.	Drug: AG-221; Continuous 28-day cycles of AG 221 100 mg orally (PO) once a day (QD) for 28 days; Other: BSC; Best supportive care includes, hydroxyurea for leukocytosis and/or differentiation-like syndrome, anti-infectives, analgesics, antiemetics, antipyretics, transfusions and nutritional support
Active Comparator: Conventional care regimen (CCR) Continuous 28-day cycles of BSC only, azacitidine subcutaneously (SC) plus BSC, low-dose cytarabine (LDAC) SC plus BSC, or intermediate-dose cytarabine (IDAC) intravenously (IV) plus BSC. Subjects will be assigned by the investigator to one of the CCR treatment options based on the investigator's assessment of subjects' eligibility.	Other: BSC; Best supportive care includes, hydroxyurea for leukocytosis and/or differentiation-like syndrome, anti-infectives, analgesics, antiemetics, antipyretics, transfusions and nutritional support; Drug: Azacitidine; continuous 28-day cycles of azacitidine 75 mg/m2/day SC for 7 days, plus BSC; Drug: Low-dose cytarabine (LDAC); continuous 28-day cycles of cytarabine 20 mg SC twice a day (BID) for 10 days, plus BSC; Drug: Intermediate-dose cytarabine (IDAC); 28-day cycles of cytarabine 0.5 to 1.5 g/m2/day IV for 3 to 6 days, per standard institutional practice, plus BSC; only BSC given after IDAC therapy concludes per standard institutional practice

Outcome Measures

Primary Outcome Measures

1. Overall survival [Up to approximately 49 months]

   Time from randomization to death due to any cause

Secondary Outcome Measures

1. Overall response rate [Up to approximately 49 months]

   The rate of morphologic leukemia-free state (MLFS) + Morphologic complete remission (CR) + Morphologic complete remission with incomplete neutrophil recovery (CRi) + Morphologic complete remission with incomplete platelet recovery (CRp) + Partial remission (PR) according to modified International Working Group (IWG) Acute myeloid leukemia (AML) response criteria

2. Event-free survival [Up to approximately 49 months]

   Time from randomization to documented morphologic relapse, PD according to modified International Working Group (IWG) Acute myeloid leukemia (AML) response criteria or death from any cause, whichever occurs first

3. Duration of response [Up to approximately 49 months]

   Time from the first documented MLFS/CR/CRi/CRp/PR to documented morphologic relapse, Progressive disease (PD) according to modified IWG AML response criteria or death due to any cause, whichever occurs first

4. Time to response [Up to approximately 49 months]

   Time from randomization to first documented MLFS/CR/CRi/CRp/PR according to modified IWG AML response criteria

5. Treatment mortality at 30 and 60 days [At 30 and 60 days after treatment start]

   Rate of death from any cause within 30 and 60 days of initiation of study treatment

6. One-year survival [Up to approximately 49 months]

   The probability of survival at 1 year from randomization

7. Overall remission rate [Up to approximately 49 months]

   Rate of CR + CRi + CRp according to modified IWG AML response criteria

8. Complete remission rate [Up to approximately 49 months]

   Rate of CR according to modified IWG AML response criteria

9. Hematologic improvement rate [Up to approximately 49 months]

   Rate of Hematologic improvement neutrophil response (HI-N) + Hematologic improvement platelet response (HI-P) + Hematologic improvement erythroid response (HI-E) according to International Working Group (IWG) Myelodysplastic syndromes (MDS) Hematologic improvement (HI) criteria

10. Rate of Hematopoietic stem cell transplantation (HSCT) [Up to approximately 49 months]

    Rate of bridge-to-HSCT through study treatment

11. Time to treatment failure [Up to approximately 49 months]

    Time from randomization to discontinuation of study treatment due to any cause response criteria or death due to any cause, whichever occurs first

12. Adverse Events (AEs) [Up to approximately 78 months]

    Number of participants with adverse events

13. European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) [Up to approximately 49 months]

    A validated quality of life measure applicable to subjects with any cancer diagnosis. .

14. EuroQoL Group EQ-5D-5L Health Questionnaire [Up to approximately 49 months]

    A standardized instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status, and is applicable to a wide range of health conditions and treatments.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

1. Subject is ≥ 60 years of age at the time of signing the ICF

2. Subject has primary (ie, de novo) or secondary (progression of MDS or myeloproliferative neoplasms ([MPN], or therapy-related) AML according to WHO classification (Appendix B)

3. Subject has received second- or third-line of AML therapy (see Appendix G for the definition of prior AML line; note that, for subjects having AML secondary to prior higher risk [Intermediate-2 or High risk according to the International Prognostic Scoring System] MDS treated with a hypomethylating agent [eg, azacitidine or decitabine], the hypomethylating therapy can be counted as a line if there is disease progression to AML during or shortly [eg, within 60 days] after the hypomethylating therapy.)

4. Subject has the following disease status:

5. Refractory to or relapsed after second- or third-line of intensive therapy for

AML (eg, the "7 + 3" regimen):

at least 5% leukemic blasts in bone marrow (the minimum number of treatment cycles of the intensive therapy is per the investigator's discretion); or

1. Refractory to or relapsed after second- or third-line low-intensity AML therapy (eg, LDAC, azacitidine or decitabine):

at least 5% leukemic blasts in bone marrow after at least 2 treatment cycles

1. Subject is eligible for and willing to receive the pre-selected CCR treatment option, according to the investigator's assessment (Note: Subjects with degenerative and toxic encephalopathies, especially after the use of methotrexate or treatment with ionizing radiation, should not receive cytarabine.)

2. Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (Appendix D)

3. Subject has IDH2 gene mutations tested centrally (using the "investigational use only"PCR assay, Abbott RealTime IDH2) in samples of bone marrow aspirate and peripheral blood, and confirmed positive in bone marrow aspirate and/or peripheral blood. (Note: in the event that the central laboratory result is delayed and precludes acute clinical management of a subject who has confirmed IDH2 gene mutation by local evaluation, the subject may be eligible for randomization with approval by the Medical Monitor.)

4. Subject has adequate organ function defined as:

• Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x upper limit of normal (ULN), unless considered due to leukemic organ involvement, following review by the Medical Monitor; and

• Serum total bilirubin ≤ 1.5 x ULN, unless considered due to Gilbert's syndrome (eg, a gene mutation in UGT1A1) or leukemic organ involvement, following review by the Medical Monitor; and

• Creatinine clearance > 30 mL/min based on the Modification of Diet in Renal

Disease (MDRD) glomerular filtration rate (GFR):

GFR (mL/min/1.73 m2) = 175 × (serum creatinine)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American)

1. Females of childbearing potential (FCBP)* may participate, providing they meet the following conditions:

• Agree to practice true abstinence from sexual intercourse or to use highly effective contraceptive methods (eg, combined [containing estrogen and progestogen] or progestogen-only associated with inhibition of ovulation, oral, injectable, intravaginal, patch, or implantable hormonal contraceptive; bilateral tubal occlusion; intra-uterine device; intrauterine hormone-releasing system; or male partner sterilization [note that vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the FCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success]) at screening and throughout the study, and for 4 months following the last study treatment (6 months following the last dose of cytarabine); and

• Have a negative serum β-subunit of human chorionic gonadotropin (β-hCG) pregnancy test (sensitivity of at least 25 mIU/mL) at screening; and

• Have a negative serum or urine (investigator's discretion under local regulations) β-hCG pregnancy test (sensitivity of at least 25 mIU/mL) within 72 hours prior to the start of study treatment in the Treatment Phase (note that the screening serum pregnancy test can be used as the test prior to the start of study treatment in the Treatment Phase if it is performed within the 72-hour timeframe).

1. Male subjects must agree to practice true abstinence from sexual intercourse or to the use of highly effective contraceptive methods (as described above) with non-pregnant female partners of childbearing potential at screening and throughout the course of the study, and should avoid conception with their partners during the course of the study and for 4 months following the last study treatment (6 months following the last dose of cytarabine; 6 months following the last dose of azacitidine in Canada)

2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted

3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Subject is suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype

2. Subject has AML secondary to chronic myelogenous leukemia

3. Subject has received a targeted agent against an IDH2 mutation

4. Subject has received systemic anticancer therapy or radiotherapy < 14 days prior to the start of study treatment. Note that hydroxyurea is allowed prior to the start of study treatment for the control of leukocytosis (however, hydroxyurea should not be given within 72 hours prior to and after administration of azacitidine).

5. Subject has received non-cytotoxic or investigational agents < 14 days or 5 half-lives, whichever is longer, prior to the start of study treatment

6. Subject has undergone HSCT within 60 days prior to the start of study treatment, or on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of a stable dose of oral steroid post-HSCT and/or topical steroids for ongoing skin GVHD is permitted.

7. Subject has persistent, clinically significant non-hematologic toxicities from prior therapies

8. Subject has or is suspected of having central nervous system (CNS) leukemia. Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening.

9. Subject has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)

10. Subject has immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation

11. Subject has significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure (Appendix E); acute coronary syndrome (ACS); and/or stroke; or left ventricular ejection fraction (LVEF) < 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 28 days prior to the start of study treatment

12. Subject has prior history of malignancy, other than MDS, MPN or AML, unless the subject has been free of the disease for ≥ 1 year prior to the start of study treatment.

However, subjects with the following history/concurrent conditions are allowed:

• Basal or squamous cell carcinoma of the skin

• Carcinoma in situ of the cervix

• Carcinoma in situ of the breast

• Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis clinical staging system)

1. Subject is known seropositive or active infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)

2. Subject is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally

3. Subjects has uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg or diastolic BP > 100 mmHg)

4. Subject is a pregnant or lactating female

5. Subject has known or suspected to have hypersensitivity to any of the components of study treatment

6. Subject is taking those medications (listed in Section 8.2) that are known to prolong QT interval unless the subject can be transferred to other medications at least 5 half-lives prior to the start of study treatment

7. Subject has QTc interval (ie, Fridericia's correction [QTcF]) ≥ 450 ms or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome) at screening

8. Subject is taking the following sensitive CYP substrate medications that have a narrow therapeutic range are excluded from the study unless the subject can be transferred to other medications at least 5 half-lives prior to the start of study treatment: paclitaxel and docetaxel (CYP2C8), phenytoin (CYP2C9), S-mephenytoin (CYP2C19), thioridazine (CYP2D6), theophylline, and tizanidine (CYP1A2)

9. Subject is taking the breast cancer resistance protein (BCRP) transporter-sensitive substrate rosuvastatin should be excluded from the study unless the subject can be transferred to other medications at least 5 half-lives prior to the start of study treatment

10. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study

11. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study

12. Subject has any condition that confounds the ability to interpret data from the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California Norris Cancer Center	Los Angeles	California	United States	90033
2	UCLA School of Medicine Hematology Oncology	Los Angeles	California	United States	90095
3	Ucla School Of Medicine	Los Angeles	California	United States	90095
4	University of Colorado Cancer Center	Aurora	Colorado	United States	80045
5	Yale University School of Medicine	New Haven	Connecticut	United States	06520
6	Shands Cancer Center University of Florida	Gainesville	Florida	United States	32610
7	University of Miami Sylvester Cancer Research Center	Miami	Florida	United States	33136
8	University of Florida Health Cancer Center at Orlando Health	Orlando	Florida	United States	32806
9	Northwestern University Medical Center	Chicago	Illinois	United States	60611
10	Rush University Medical Center	Chicago	Illinois	United States	60612
11	University of Chicago Medical Center	Chicago	Illinois	United States	60637
12	Northshore University Healthsystem Research Institute	Evanston	Illinois	United States	60201
13	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
14	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
15	Montefiore Medical Center Albert Einstein Cancer Center	Bronx	New York	United States	10467
16	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
17	Mount Sinai School of Medicine	New York	New York	United States	10029
18	Strong Health System	Rochester	New York	United States	14642
19	Duke University Medical Center	Durham	North Carolina	United States	27705
20	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
21	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
22	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States	17033
23	Cancer Center of the Carolinas	Greenville	South Carolina	United States	29615
24	Sarah Cannon Research Inst	Nashville	Tennessee	United States	37203
25	Baylor Sammons Cancer Center	Dallas	Texas	United States	75246
26	MD Anderson Cancer Center The University of Texas	Houston	Texas	United States	77030
27	West Virginia University CTRU	Morgantown	West Virginia	United States	25606
28	Concord Repatriation General Hospital	Concord	New South Wales	Australia	2139
29	Royal Adelaide Hospital Institute of Medical and Veterinary Science	Adelaide	South Australia	Australia	5000
30	Peter MacCallum Cancer Centre - East Melbourne	East Melbourne		Australia	3002
31	Royal Brisbane Hospital	Herston		Australia	4029
32	The Alfred Hospital	Melbourne		Australia	3004
33	Royal Prince Alfred Hospital	Sydney		Australia	NSW 2050
34	Medical University of Graz	Graz		Austria	A-8036
35	Elisabethinen Hospital Linz	Linz		Austria	4020
36	Klinik fur Innere Medizin III	Wien		Austria	1090
37	AZ St-Jan Brugge Oostende AV	Brugge		Belgium	8000
38	UZ Gent	Gent		Belgium	9000
39	Cliniques Universitaires UCL de Mont-Godine	Yvoir		Belgium	5530
40	Hospital de Clinicas de Porto Alegre	Porto Alegre, RS	Rio Grande Do Sul	Brazil	90035-003
41	Santa Casa de Porto Alegre	Porto Alegre	Rio Grande Do Sul	Brazil	90020-090
42	Fundacao Hospital Amaral Carvalho	Jau		Brazil	17210-080
43	HEMORIO - Unidade de Pesquisa Clínica	Rio de Janeiro		Brazil	20211-030
44	Sociedade Beneficente de Senhoras Hospital Sirio Libanes	São Paulo		Brazil	01308-050
45	University of Alberta	Edmonton	Alberta	Canada	T6G2V2
46	Cancer Care Manitoba	Winnipeg	Manitoba	Canada	R3E OV9
47	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9
48	Local Institution - 204	Montreal	Quebec	Canada	H3A 1A1
49	McGill University Health Center	Montreal	Quebec	Canada	H3A 1A1
50	The First Hospital of China Medical University	Beijing		China	100080
51	Peking University Third Hospital	Beijing		China	100191
52	Chinese PLA General Hospital	Beijing		China	100853
53	First Hospital of Jilin University	Changchun		China	130021
54	The Third Xiangya hospital of central south university	Changsha		China	410013
55	West China Hospital	Chengdu, Sichuan		China	610041
56	Fujian Medical University Union Hospital	Fuzhou		China	350001
57	Guangdong General Hospital	Guangzhou, Guangdong		China	510080
58	The First Affiliated Hospital of Medical School of Zhejiang University	Hangzhou City		China	310003
59	Local Institution - 883	Hangzhou City		China	310006
60	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai		China	200025
61	Changhai Hospital	Shanghai		China	200433
62	Institution of Hematology & Hospital of Blood Disease, Chinese Academy of Medical Sciences	Tianjin		China	300020
63	Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology	Wuhan		China	430030
64	Henan Cancer Hospital	Zhengzhou		China
65	Fakultni nemocnice Brno	Brno		Czechia	625 00
66	Fakultni nemocnice Hradec Kralove	Hradec Kralove		Czechia	500 05
67	Local Institution - 822	Praha		Czechia	128 08
68	Vseobecna Fakultni Nemocnice v Praze	Praha		Czechia	128 08
69	Aalborg Universitetshospital	Aalborg		Denmark	9000
70	Aarhus Sygehus	Arhus C		Denmark	DK-8000
71	Copenhagen University Hospital Rigshosptalet	Copenhagen		Denmark	2100
72	Odense University Hospital	Odense		Denmark	DK-5000
73	CHU d'Angers	Angers		France	49033
74	Hopital Aviecenne	BOBIGNY Cedex		France	93009
75	CHU Hotel	Grenoble Cedex 09		France	38043
76	CHRU Claude Huriez	Lille		France	59037
77	Local Institution - 602	Lille		France	59037
78	Institut Paoli Calmette Hematologie	Marseille cedex		France	13273
79	CHRU Nantes	Nantes		France	44093
80	Hopital Saint Louis	Paris		France	75475
81	Hospital haut leveque	Pessac		France	33604
82	Centre Hospitalier Lyon Sud	Pierre-Bénite Cedex		France	69495
83	Hopital Purpan	Toulouse Cedex		France	31009
84	Centre Hospitalier de Versailles	Versailles		France	78000
85	Gustave Roussy	Villejuif CEDEX		France	94805
86	Local Institution - 604	Villejuif CEDEX		France	94805
87	Unviversitatsklinikum Aachen	Aachen		Germany	52074
88	Universitatsklinikum Carl Gustav Carus an der TU Dresden	Dresden		Germany	D-01307
89	Universitatsklinikum Essen	Essen		Germany	45122
90	Universitatsklinikum Frankfurt	Frankfurt		Germany	60590
91	Universitatsklinikum Freiburg	Freiburg		Germany	79106
92	Medizinische Hochschule HannoverZentrum Innere Medizin	Hannover		Germany	30625
93	SLK Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen	Heilbronn		Germany	74078
94	Universitatsklinikum Leipzig	Leipzig		Germany	04103
95	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz		Germany	55131
96	LMU Klinikum der Universitat	München		Germany	81377
97	TU München - Klinikum rechts der Isar	München		Germany	81675
98	Robert Bosch Krankenhaus	Stuttgart		Germany	70376
99	Universitaetsklinikum Tuebingen	Tuebingen		Germany	72076
100	University Hospital of Ulm	Ulm		Germany	89081
101	Policlinico S. Orsola - Malpighi	Bologna		Italy	40138
102	AO Spedali Civili di Brescia	Brescia		Italy	25123
103	Hematology Dept Azienda Ospedaliero Universitaria Careggi	Firenze		Italy	50139
104	Ospedale Cardarelli	Naples		Italy	80131
105	Hospital of Di Padova	Padova		Italy	35128
106	Casa di Cura La Maddalena	Palermo		Italy	90146
107	Azienda Ospedaliera "Bianchi-Melacrino-Morelli"	Reggio Calabria		Italy	89100
108	Local Institution - 303	Reggio Calabria		Italy	89100
109	Fondazione PTV Policlinico Tor Vergata	Roma		Italy	00133
110	Ospedale di Circolo di Varese	Varese		Italy	21100
111	Hwasun Chonnam National University Hospital	Hwasun-gun		Korea, Republic of	519-809
112	Seoul National University Hospital	Seoul		Korea, Republic of	03080
113	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	120-752
114	Samsung Medical Center	Seoul		Korea, Republic of	135-710
115	The Catholic University of Korea Seoul - Saint Mary's Hospital	Seoul		Korea, Republic of	137-701
116	Krasnoyarsk Regional Clinical Hospital	Krasnoyarsk		Russian Federation	660022
117	City Clinical Hospital 52	Moscow		Russian Federation	123182
118	City Clinical Hospital 40	Moscow		Russian Federation	129301
119	St. Petersburg Research Institute of Hematology and Blood Transfusion	Saint-Petersburg		Russian Federation	191024
120	Hospital Universitario La Fe	Avda, Campanar 21		Spain	46009
121	Hospital Universitario Vall D hebron	Barcelona		Spain	08035
122	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041
123	Hospital Clinic I Provincial de Barcelona	Barcelona		Spain	8036
124	Hospital Universitario La Princesa	Madrid		Spain	28006
125	Hospital General Gregorio Maranon	Madrid		Spain	28007
126	Hospital Universitario Central de Asturias	Oviedo		Spain	33006
127	Hospital Universitario de Salamanca	Salamanca		Spain	37007
128	Hospital Universitario Virgen Del Rocio	Sevilla		Spain	41013
129	China Medical University Hospital	Taichung, Northern Dist.		Taiwan	404
130	National Taiwan University Hospital	Taipei, Zhongzheng Dist.		Taiwan	10002
131	Chang Gung Medical Foundation-Linkou Branch	Taoyuan		Taiwan	333
132	Hacettepe Universitesi Tip Fakultesi Hastanesi	Ankara		Turkey	06100
133	Dr. Abdurrahman Yurtaslan Ankara Onkoloji hospital	Ankara		Turkey	06200
134	Gazi Universitesi Tip Fakultesi Hastanesi	Ankara		Turkey	6500
135	Pamukkale University Medical Faculty	Denizli		Turkey	20070
136	Gaziantep University	Gaziantep		Turkey	27310
137	University Hospital of Wales - Cardiff	Cardiff		United Kingdom	CF14 4XW
138	Queens Centre for Oncology & Haematology	Hull		United Kingdom	HU16 5JQ
139	St Bart's London	London		United Kingdom	EC1A 7BE
140	Kings College Hospital	London		United Kingdom	SE5 9RS
141	Christie Hospital NHS Trust	Manchester Withington		United Kingdom	M20 4BX
142	Nottingham City Hospital	Nottingham		United Kingdom	NG5 1PB
143	John Radcliffe Hospital The Oxford Radcliffe Hospital Clinical Haematology	Oxford		United Kingdom	OX3 9DU
144	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield South Yorkshire		United Kingdom	S10 2SJ
145	Royal Marsden Hospital	Sutton (Surrey)		United Kingdom	SM2 5PT
146	Spire Little Aston Hospital	West Midlands		United Kingdom	B9 5SS

Sponsors and Collaborators

• Celgene

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT02577406
• Other Study ID Numbers: AG-221-AML-004
• First Posted: Oct 16, 2015
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by Celgene: AG-221; CC-90007; Efficacy; Safety; Leukemia; Acute myeloid meukemia; Isocitrate dehydrogenase 2 mutation; Enasidenib
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Cytarabine; Azacitidine

Study Results

No Results Posted as of Jun 9, 2022