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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02577406




Registration number
NCT02577406
Ethics application status
Date submitted
14/10/2015
Date registered
16/10/2015
Date last updated
24/05/2019

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
AG-221-AML-004
Universal Trial Number (UTN)
Trial acronym
IDHENTIFY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid 0 0
Isocitrate Dehydrogenase 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - AG-221
Other interventions - BSC
Treatment: Drugs - Azacitidine
Treatment: Drugs - Low-dose cytarabine (LDAC)
Treatment: Drugs - Intermediate-dose cytarabine (IDAC)

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.

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.


Treatment: Drugs: AG-221
Continuous 28-day cycles of AG 221 100 mg orally (PO) once a day (QD) for 28 days

Other interventions: BSC
Best supportive care includes, hydroxyurea for leukocytosis and/or differentiation-like syndrome, anti-infectives, analgesics, antiemetics, antipyretics, transfusions and nutritional support

Treatment: Drugs: Azacitidine
continuous 28-day cycles of azacitidine 75 mg/m2/day SC for 7 days, plus BSC

Treatment: Drugs: Low-dose cytarabine (LDAC)
continuous 28-day cycles of cytarabine 20 mg SC twice a day (BID) for 10 days, plus BSC

Treatment: Drugs: 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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival - Time from randomization to death due to any cause
Timepoint [1] 0 0
Up to approximately 49 months
Secondary outcome [1] 0 0
Overall response rate - 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
Timepoint [1] 0 0
Up to approximately 49 months
Secondary outcome [2] 0 0
Event-free survival - 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
Timepoint [2] 0 0
Up to approximately 49 months
Secondary outcome [3] 0 0
Duration of response - 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
Timepoint [3] 0 0
Up to approximately 49 months
Secondary outcome [4] 0 0
Time to response - Time from randomization to first documented MLFS/CR/CRi/CRp/PR according to modified IWG AML response criteria
Timepoint [4] 0 0
Up to approximately 49 months
Secondary outcome [5] 0 0
Treatment mortality at 30 and 60 days - Rate of death from any cause within 30 and 60 days of initiation of study treatment
Timepoint [5] 0 0
At 30 and 60 days after treatment start
Secondary outcome [6] 0 0
One-year survival - The probability of survival at 1 year from randomization
Timepoint [6] 0 0
Up to approximately 49 months
Secondary outcome [7] 0 0
Overall remission rate - Rate of CR + CRi + CRp according to modified IWG AML response criteria
Timepoint [7] 0 0
Up to approximately 49 months
Secondary outcome [8] 0 0
Complete remission rate - Rate of CR according to modified IWG AML response criteria
Timepoint [8] 0 0
Up to approximately 49 months
Secondary outcome [9] 0 0
Hematologic improvement rate - 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
Timepoint [9] 0 0
Up to approximately 49 months
Secondary outcome [10] 0 0
Rate of Hematopoietic stem cell transplantation (HSCT) - Rate of bridge-to-HSCT through study treatment
Timepoint [10] 0 0
Up to approximately 49 months
Secondary outcome [11] 0 0
Time to treatment failure - Time from randomization to discontinuation of study treatment due to any cause response criteria or death due to any cause, whichever occurs first
Timepoint [11] 0 0
Up to approximately 49 months
Secondary outcome [12] 0 0
Adverse Events (AEs) - Number of participants with adverse events
Timepoint [12] 0 0
Up to approximately 78 months
Secondary outcome [13] 0 0
European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) - A validated quality of life measure applicable to subjects with any cancer diagnosis. .
Timepoint [13] 0 0
Up to approximately 49 months
Secondary outcome [14] 0 0
EuroQoL Group EQ-5D-5L Health Questionnaire - 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.
Timepoint [14] 0 0
Up to approximately 49 months

Eligibility
Key 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:

1. 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

2. 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

5. 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.)

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

7. 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.)

8. 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)

9. 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 ß-subunit of human chorionic gonadotropin (ß-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) ß-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).

10. 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)

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

12. Subject is willing and able to adhere to the study visit schedule and other protocol
requirements
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

13. 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)

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

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

16. Subject is a pregnant or lactating female

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

18. 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

19. 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

20. 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)

21. 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

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

23. 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

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Royal Adelaide Hospital Institute of Medical and Veterinary Science - Adelaide
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - East Melbourne - East Melbourne
Recruitment hospital [4] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
NSW 2050 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
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Colorado
Country [3] 0 0
United States of America
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Connecticut
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Florida
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Illinois
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Massachusetts
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United States of America
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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United States of America
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West Virginia
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Austria
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Graz
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Austria
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Linz
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Austria
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Wien
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Belgium
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Brugge
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Belgium
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Gent
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Belgium
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Yvoir
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Brazil
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Rio Grande Do Sul
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Brazil
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Jau
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Brazil
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Porto Alegre, RS
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Rio de Janeiro
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São Paulo
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Alberta
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Canada
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Manitoba
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Ontario
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China
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Beijing
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Changchun
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Changsha
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Chengdu, Sichuan
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China
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Fuzhou
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China
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Guangzhou, Guangdong
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China
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Hangzhou City
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China
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Shanghai
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China
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Tianjin
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China
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Wuhan
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China
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Zhengzhou
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Praha
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Denmark
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Aalborg
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Denmark
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Arhus C
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Denmark
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Copenhagen
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Denmark
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Odense
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France
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Angers
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France
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BOBIGNY Cedex
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Grenoble Cedex 09
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Lille
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Nantes
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Pessac
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Pierre-Bénite Cedex
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Toulouse Cedex
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France
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Versailles
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Villejuif CEDEX
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Germany
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Aachen
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Germany
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Dresden
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Hannover
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Germany
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Heilbronn
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Germany
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Leipzig
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Germany
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Mainz
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München
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Germany
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Stuttgart
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Germany
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Tuebingen
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Ulm
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Bologna
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Brescia
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Firenze
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Italy
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Naples
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Orbassano
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Italy
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Padova
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Italy
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Palermo
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Italy
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Reggio Calabria
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Italy
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Roma
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Italy
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Varese
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Korea, Republic of
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Hwasun-gun
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Korea, Republic of
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Seoul
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Spain
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Avda, Campanar 21
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Oviedo
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Spain
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Salamanca
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Spain
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Sevilla
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Taiwan
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Taichung, Northern Dist.
Country [96] 0 0
Taiwan
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Taipei, Zhongzheng Dist.
Country [97] 0 0
Taiwan
State/province [97] 0 0
Taoyuan
Country [98] 0 0
Turkey
State/province [98] 0 0
Ankara
Country [99] 0 0
Turkey
State/province [99] 0 0
Denizli
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Turkey
State/province [100] 0 0
Gaziantep
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Cardiff
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Hull
Country [103] 0 0
United Kingdom
State/province [103] 0 0
London
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United Kingdom
State/province [104] 0 0
Manchester Withington
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Nottingham
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Oxford
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Sheffield South Yorkshire
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Sutton (Surrey)
Country [109] 0 0
United Kingdom
State/province [109] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02577406
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kazunobu Kato, MD
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Celgene Corporation
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Contact person for public queries
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Associate Director Clinical Trial Disclosure
Address 0 0
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Phone 0 0
1-888-260-1599
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clinicaltrialdisclosure@celgene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02577406