Acute Myeloid Leukemia Clinical Trial
Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.
Be â‰¥ 18 years of age and meet at least 1 of the following criteria defining ineligibility for intensive induction chemotherapy (IC): â‰¥ 75 years old, Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 2, severe cardiac disorder (e.g., congestive heart failure requiring treatment, left ventricular ejection fraction (LVEF), â‰¤50%, or chronic stable angina), severe pulmonary disorder (e.g., diffusing capacity of the lungs for carbon monoxide â‰¤65% or forced expiratory volume in 1 second â‰¤65%), creatinine clearance <45 mL/minute, bilirubin >1.5 times the upper limit of normal (ULN) and/or have any other comorbidity that the Investigator judges to be incompatible with intensive IC and must be reviewed and approved by the Medical Monitor before study enrollment.
Have previously untreated AML, defined according to World Health Organization (WHO) criteria, with â‰¥ 20% leukemic blasts in the bone marrow. Participants with extramedullary disease alone (i.e., no detectable bone marrow and no detectable peripheral blood AML) are not eligible for the study.
Have an isocitrate dehydrogenase 1 (IDH1) mutation.
Have an ECOG PS score of 0 to 2.
Have adequate hepatic function.
Have adequate renal function.
Have agreed to undergo serial blood and bone marrow sampling.
Be able to understand and willing to sign an informed consent form (ICF).
Be willing to complete Quality of Life assessments during the study
If female with reproductive potential, must have a negative serum pregnancy test prior to the start of study therapy. Females of reproductive potential, as well as fertile men and their female partners of reproductive potential, must agree to use 2 effective forms of contraception.
Are candidates for and willing to receive intensive induction chemotherapy (IC) for their AML.
Have received any prior treatment for AML with the exception of hydroxyurea.
Have received a hypomethylating agent for myelodysplastic syndrome (MDS).
Participants who had previously received an experimental agent for MDS may not be randomized until a washout period has elapsed since the last dose of that agent.
Have received prior treatment with an IDH1 inhibitor.
Have a known hypersensitivity to any of the components of AG-120, matched placebo, or azacitidine.
Are female and pregnant or breastfeeding.
Have an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
Have a prior history of cancer other than MDS or myeloproliferative disorder, unless the participant has been free of the disease for â‰¥ 1 year prior to the start of study treatment.
Have had significant active cardiac disease within 6 months prior to the start of the study treatment.
Have any condition that increases the risk of abnormal ECG or cardiac arrhythmia.
Have a condition that limits the ingestion or absorption of drugs administered by mouth.
Have uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg or diastolic BP > 100 mmHg).
Have clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia.
Have immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or disseminated intravascular coagulation.
Have any other medical or psychological condition deemed by the Investigator to be likely to interfere with the participant's ability to give informed consent or participate in the study.
Are taking medications that are known to prolong the QT interval unless they can be transferred to other medications within â‰¥5 half-lives prior to dosing, or unless the medications can be properly monitored during the study. (If equivalent medication is not available, heart rate corrected QT interval [QTc] will be closely monitored.)
Have a known medical history of progressive multifocal leukoencephalopathy.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 86 Locations for this study
Louisville Kentucky, 40207, United States
Boston Massachusetts, 02114, United States
Camperdown New South Wales, 2050, Australia
Adelaide South Australia, 5000, Australia
Bedford park South Australia, 5042, Australia
Salzburg , 5020, Austria
Wien , 1130, Austria
Campinas Sao Paulo, 13083, Brazil
Jau Sao Paulo, 17210, Brazil
Porto Alegre , 90035, Brazil
Rio De Janeiro , 20230, Brazil
Sao Paulo , 01308, Brazil
Sao Paulo , 01321, Brazil
Sao Paulo , 08270, Brazil
Winnipeg Manitoba, R3E 0, Canada
Toronto Ontario, M5G 2, Canada
Zhengzhou Henan, 45000, China
Chengdu Sichuan, 61004, China
Beijing , , China
Guangzhou , 51008, China
Hangzhou , 31000, China
Tianjin , 30002, China
Ostrava , , Czechia
Pessac Gironde, 33604, France
Tours Indre-et-Loire, 37044, France
Nantes Loire-Atlantique, 44093, France
Pierre-benite Rhone, 69495, France
Le Mans Sarthe, 72037, France
Brest , 29609, France
Caen , 14000, France
Grenoble , 38043, France
Le Chesnay , 78 15, France
Paris , 75015, France
Poitiers , 86021, France
Strasbourg , 67200, France
Toulouse , 31059, France
Villejuif , 94805, France
Essen Nordrhein-Westfalen, 45122, Germany
Chemnitz Sachsen, 09113, Germany
Berlin , 13353, Germany
Hannover , 30625, Germany
Leipzig , 04103, Germany
Munchen , 81377, Germany
Ulm , 89081, Germany
Petah Tikva , 49100, Israel
Rehovot , 76100, Israel
Varese Lombardia, 21100, Italy
Meldola , 47014, Italy
Milano , 20132, Italy
Milano , 20162, Italy
Pavia , 27100, Italy
Rimini , 47900, Italy
Torino , 10126, Italy
Matsuyama Ehime, 790-8, Japan
Fukui , 910-1, Japan
Himeji , 670-8, Japan
Kobe , , Japan
Goyang-si Gyeonggido, 10408, Korea, Republic of
Suwon-si Gyeonggido, 16499, Korea, Republic of
Busan , 602-7, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 110-7, Korea, Republic of
Culiacan , 80230, Mexico
Mexico , 14000, Mexico
Amsterdam Noord-Holland, 1081 , Netherlands
Nijmegen , 6525 , Netherlands
Wroclaw Dolnoslaskie, 50-36, Poland
Warszawa Mazowieckie, 02-77, Poland
Gdansk , 80-21, Poland
Kaluga , 24800, Russian Federation
Moscow , 12930, Russian Federation
Volgograd , 40013, Russian Federation
Santiago de Compostela A Coruna, 15706, Spain
Palma de Mallorca Baleares, 07010, Spain
Badalona Barcelona, 08916, Spain
Las Palmas de Gran Canaria Las Palmas, 35010, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Changhua City , 500, Taiwan
Kaohsiung , 807, Taiwan
Taichung City , 40447, Taiwan
Tainan City , 736, Taiwan
Taipei , , Taiwan
Birmingham West Midlands, B9 5S, United Kingdom
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.