Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
NCT ID: NCT02719574
Last Updated: 2025-06-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
336 participants
INTERVENTIONAL
2016-04-30
2024-01-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)
NCT02775903
Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS
NCT03066648
A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm
NCT06597734
The Efficacy of Azacitidine +/- Lenalidomide in High-risk Myelodysplastic Syndrome (MDS)and Acute Myeloid Leukemia (AML) With Del(5q).
NCT01556477
Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes
NCT01324960
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PH1 Dose Escalation & Expansion FT-2102 (olutasidenib)
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Azacitidine
azacitidine will be administered per site's standard of care
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Cytarabine
low-dose cytarabine will be administered per site's standard of care
PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent
Relapsed or Refractory (R/R) AML
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent
AML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
PH2 Cohort 3 FT-2102 (olutasidenib) Single Agent
R/R AML/MDS, previously treated with FT-2102
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine
R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Azacitidine
azacitidine will be administered per site's standard of care
PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine
R/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Azacitidine
azacitidine will be administered per site's standard of care
PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine
R/R AML/MDS that have been previously treated with single-agent FT-2102 as their last therapy prior to study enrollment
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Azacitidine
azacitidine will be administered per site's standard of care
PH2 Cohort 7 FT-2102 (olutasidenib) Single Agent
Treatment naïve AML for whom standard treatments are contraindicated
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine
Treatment naïve AML who are candidates for azacitidine first line treatment
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Azacitidine
azacitidine will be administered per site's standard of care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Azacitidine
azacitidine will be administered per site's standard of care
Cytarabine
low-dose cytarabine will be administered per site's standard of care
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site
* Good performance status
* Good kidney and liver function
Exclusion Criteria
* Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Forma Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA Medical Center
Los Angeles, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York Medical College
Hawthorne, New York, United States
Columbia University Medical Center
New York, New York, United States
Cornell University Weill Medical College
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Victoria Cancer Care Center
Parkville, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Box Hill Hospital, Monash University and Eastern Health Clinical School
Box Hill, , Australia
Princess Margaret Hospital
Toronto, Ontario, Canada
Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris
Bobigny, , France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord
Marseille, , France
Centre Hospitalier Universitaire Nantes
Nantes, , France
Hôpital Saint-Louis
Paris, , France
Hopitaux Universitaires Est Parisien Hopital Saint-Antoine
Paris, , France
Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
University Hospital of Rennes
Rennes, , France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, , France
Centre Hospitalier Universitaire de Nancy - Hopital Brabois
Vandœuvre-lès-Nancy, , France
Institut de Cancérologie Gustave Roussy
Villejuif, , France
Staedtisches Klinikum Braunschweig gGmbH
Braunschweig, , Germany
Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin
Giessen, , Germany
Landeszentrum fuer Zell- und Gentherapie
Halle, , Germany
Universitätsklinikum Münster Medizinische Klinik A, Hämatologie, Hämostaseologi
Münster, , Germany
AOU S. Luigi Gonzaga - Orbassano
Orbassano, Turin, Italy
Ospedale Mazzoni - UOC Ematologia Ascoli Piceno
Ascoli Piceno, , Italy
Universita di Bologna
Bologna, , Italy
Dipartimento di Oncologia Medica - IRST IRCC
Meldola, , Italy
Università degli Studi di Parma
Parma, , Italy
U.O. Ematologia Ravenna
Ravenna, , Italy
Hospital Rimini Hematology, Department of Oncology and Hematoloy
Rimini, , Italy
Seoul National University Bundang Hospital
Gumi, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Institut Català d'Oncologia-Hospital Duran i Reynals
Barcelona, , Spain
Hospital Universitario 12 De Octubre
Madrid, , Spain
Hospital Clínico Universitario de Salamanca
Salamanca, , Spain
Hospital La Fe
Valencia, , Spain
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
St. George's University Hospital
London, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cortes JE, Yang J, Roboz GJ, Dinner SN, Wang ES, Wei AH, Tian H, di Trapani F, Baer MR, Donnellan WB, Watts JM. Olutasidenib alone or combined with azacitidine in patients with mutant IDH1 myelodysplastic syndrome. Blood Adv. 2025 Jul 16:bloodadvances.2025016718. doi: 10.1182/bloodadvances.2025016718. Online ahead of print.
Cortes JE, Roboz GJ, Baer MR, Jonas BA, Schiller GJ, Yee K, Ferrell PB, Yang J, Wang ES, Blum WG, Mims A, Tian H, Sheppard A, de Botton S, Montesinos P, Curti A, Watts JM; Olutasidenib Combination Therapy Study Group. Olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial. J Hematol Oncol. 2025 Jan 16;18(1):7. doi: 10.1186/s13045-024-01657-z.
de Botton S, Fenaux P, Yee K, Recher C, Wei AH, Montesinos P, Taussig DC, Pigneux A, Braun T, Curti A, Grove C, Jonas BA, Khwaja A, Legrand O, Peterlin P, Arnan M, Blum W, Cilloni D, Hiwase DK, Jurcic JG, Krauter J, Thomas X, Watts JM, Yang J, Polyanskaya O, Brevard J, Sweeney J, Barrett E, Cortes J. Olutasidenib (FT-2102) induces durable complete remissions in patients with relapsed or refractory IDH1-mutated AML. Blood Adv. 2023 Jul 11;7(13):3117-3127. doi: 10.1182/bloodadvances.2022009411.
Watts JM, Baer MR, Yang J, Prebet T, Lee S, Schiller GJ, Dinner SN, Pigneux A, Montesinos P, Wang ES, Seiter KP, Wei AH, De Botton S, Arnan M, Donnellan W, Schwarer AP, Recher C, Jonas BA, Ferrell PB Jr, Marzac C, Kelly P, Sweeney J, Forsyth S, Guichard SM, Brevard J, Henrick P, Mohamed H, Cortes JE. Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial. Lancet Haematol. 2023 Jan;10(1):e46-e58. doi: 10.1016/S2352-3026(22)00292-7. Epub 2022 Nov 10.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2102-HEM-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.