Acute Myeloid Leukemia Clinical Trial

A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy

Summary

The purpose of this study are

to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and,
to investigate the safety, tolerability, and efficacy of the combinations of AG-120 with azacitidine and AG-221 with azacitidine versus with azacitidine alone in participants with acute myeloid leukemia (AML) with the isocitrate dehydrogenase (IDH) enzyme isoforms 1 or 2 mutations, respectively.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed, primary (ie, de novo) or secondary (progression of Myelodysplastic syndrome [MDS] or myeloproliferative neoplasms [MPN], or therapy-related) acute myeloid leukemia (AML) according to the WHO classification with ≥ 20% leukemic blasts in the bone marrow
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Agree to serial bone marrow aspirate/biopsies

Exclusion Criteria:

Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype
AML secondary to chronic myelogenous leukemia (CML)
Received a targeted agent against an isocitrate dehydrogenase 1 (IDH1) or isocitrate dehydrogenase 2 (IDH2) mutation
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

Other protocol defined inclusion/exclusion criteria apply

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT02677922

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 63 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
Local Institution - 107
New Haven Connecticut, 06510, United States
Yale Cancer Center
New Haven Connecticut, 06510, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Chicago
Chicago Illinois, 60637, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Sarah Cannon Research Inst
Nashville Tennessee, 37203, United States
UT Southwestern Medical Center at Dallas
Dallas Texas, 75390, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Royal Adelaide Hospital
Adelaide South Australia, SA 50, Australia
Parkville Cancer Clinical Trials Unit
Melbourne , 3000, Australia
The Alfred Hospital
Melbourne , 3141, Australia
Royal Perth Hospital
Perth , 6000, Australia
Princess Margaret Hospital, Medical Oncology
Toronto Ontario, M5G 2, Canada
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang
Lille , 59037, France
Institut Paoli Calmettes
Marseille Cedex 9 , 13273, France
Centre Hospitalier Universitaire de Nantes
Nantes , 44093, France
Hopital Saint Louis
Paris Cedex 10 , 75475, France
Hospital haut leveque
Pessac , 33604, France
Centre Hospitalier Lyon Sud
Pierre Benite , 69495, France
Institut Universitaire du Cancer Oncopole
Toulouse , 31059, France
CHRU Hopital Bretonneau
Tours cedex , 37044, France
Institut Gustave Roussy
Villejuif CEDEX , 94805, France
Local Institution - 201
Villejuif CEDEX , 94805, France
Medizinische Klinik III Klinikum der Universität München-Großhadern
Berlin , 12200, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden , 01307, Germany
Heinrich Heine Universitat Dusseldorf
Düsseldorf , 40225, Germany
Universitatsklinikum Frankfurt
Frankfurt , 60590, Germany
Zentrum Innere Medizin Klinik fur Hamatologie
Hannover , 30625, Germany
Universitatsklinikum Ulm
Ulm , 89081, Germany
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna , 40138, Italy
Azienda Ospedaliero-Universitaria Careggi
Firenze , 50134, Italy
Azienda Ospedaliera Universitaria S. Martino di Genova
Genova , 16132, Italy
Azienda Ospedaliera San Luigi Gonzaga
Orbassano , 10043, Italy
Local Institution - 251
Orbassano , 10043, Italy
Hospital of Di Padova
Padova , 35128, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord AORMN
Pesaro , 31122, Italy
Azienda Ospedaliera S. Andrea - Università La Sapienza
Roma , 00189, Italy
Local Institution - 255
Roma , 00189, Italy
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul , 137-7, Korea, Republic of
Asan Medical Center
Seoul , 138-7, Korea, Republic of
Local Institution - 350
Seoul , 138-7, Korea, Republic of
VU University Medical Center
Amsterdam , , Netherlands
Universitair Medisch Centrum Groningen
Groningen , 9713 , Netherlands
Erasmus University Medical Center
Rotterdam , 3015 , Netherlands
University Medical Center Utrecht
Utrecht , 3584 , Netherlands
Instituto Portugues de Oncologia de Lisboa
Lisboa , 1099-, Portugal
Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos
Lisboa , 1169-, Portugal
Instituto Portugues de Oncologia do Porto
Porto , 4200-, Portugal
H Clinic I Provincial
Barcelona , 08036, Spain
Hospital de Bellvitge
Barcelona , 08907, Spain
Local Institution - 375
Barcelona , 08907, Spain
Hospital Universitario Vall D Hebron
Barcelona , 8035, Spain
Hospital General de la Palma
Breña Alta , 38713, Spain
Hospital San Pedro de Alcantara
Caceres , 10005, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28007, Spain
M. D. Anderson
Madrid , 28033, Spain
Hospital General Carlos Haya
Malaga , 29010, Spain
Hospital Universitario La Fe
Valencia , 46009, Spain
UniversitatsSpital Basel
Basel , 4031, Switzerland
Centre Hospitalier Universitaire Vaudois CHUV BH-04
Lausanne , 1011, Switzerland
Universitatsspital Zurich
Zurich , , Switzerland
Queen Elizabeth Hospital UHB NHS Foundation Trust
Birmingham , B15 2, United Kingdom
John Radcliffe Hospital
Headington , OX3 9, United Kingdom
Local Institution - 427
Headington , OX3 9, United Kingdom
Leeds Teaching Hospitals Trust
Leeds , LS7 4, United Kingdom
Barts Cancer Institute, Queen Mary University of London, Charterhouse Square
London , EC1M , United Kingdom
King's College Hospital
London , SE5 9, United Kingdom
Royal Marsden Hospital
Sutton (Surrey) , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT02677922

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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