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New drug targets genetic weakness in Hard-to-Treat blood cancers

NCT ID NCT02719574

Disease control Sponsor: Forma Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests a drug called FT-2102 (olutasidenib) in people with acute myeloid leukemia or myelodysplastic syndrome whose cancers have a specific IDH1 gene mutation. The drug is given alone or combined with standard chemotherapy drugs (azacitidine or cytarabine). The goal is to see if it is safe and effective at shrinking or eliminating the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FT-2102 (olutasidenib)
What this could lead to
If successful, this could provide a new targeted treatment option for people with IDH1-mutated AML or MDS, potentially improving remission rates.
What could go wrong
This is an early-phase trial, so the drug may not work as hoped or could cause serious side effects. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

336 people

The number who actually took part.

Started

Apr 2016

Finished

Jan 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pathologically proven acute myeloid leukemia (AML) (except acute promyelocytic leukemia \[APL\] with the t(15;17) translocation) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy. * Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site * Good performance status * Good kidney and liver function Exclusion Criteria: * Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy * 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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myelogenous leukemia Acute myeloid leukemia Myelodysplastic syndrome

Contacts and locations

Locations

  • AOU S. Luigi Gonzaga - Orbassano

    Orbassano, Turin, Italy

  • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord

    Marseille, 13005, France

  • Box Hill Hospital, Monash University and Eastern Health Clinical School

    Box Hill, 3128, Australia

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque

    Pessac, 33604, France

  • Centre Hospitalier Universitaire Nantes

    Nantes, 44093, France

  • Centre Hospitalier Universitaire de Nancy - Hopital Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • Churchill Hospital

    Oxford, United Kingdom

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Cornell University Weill Medical College

    New York, New York, 10065, United States

  • Dipartimento di Oncologia Medica - IRST IRCC

    Meldola, Italy

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Hopitaux Universitaires Est Parisien Hopital Saint-Antoine

    Paris, 75012, France

  • Hospital Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital La Fe

    Valencia, 46026, Spain

  • Hospital Rimini Hematology, Department of Oncology and Hematoloy

    Rimini, Italy

  • Hospital Universitario 12 De Octubre

    Madrid, 28041, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hôpital Saint-Louis

    Paris, 75010, France

  • Institut Català d'Oncologia-Hospital Duran i Reynals

    Barcelona, 8908, Spain

  • Institut Universitaire du Cancer Toulouse - Oncopole

    Toulouse, 31059, France

  • Institut de Cancérologie Gustave Roussy

    Villejuif, 94805, France

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Landeszentrum fuer Zell- und Gentherapie

    Halle, Germany

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • New York Medical College

    Hawthorne, New York, 10532, United States

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    Portland, Oregon, 97229, United States

  • Ospedale Mazzoni - UOC Ematologia Ascoli Piceno

    Ascoli Piceno, Italy

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • Sarah Cannon Research Institute - Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Seoul National University Bundang Hospital

    Gumi, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris

    Bobigny, 93000, France

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • Southampton General Hospital

    Southampton, United Kingdom

  • St. George's University Hospital

    London, United Kingdom

  • Staedtisches Klinikum Braunschweig gGmbH

    Braunschweig, Germany

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • U.O. Ematologia Ravenna

    Ravenna, Italy

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • UCLA Medical Center

    Los Angeles, California, 90024, United States

  • Universita di Bologna

    Bologna, Italy

  • Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin

    Giessen, Germany

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG, United Kingdom

  • University Hospital of Rennes

    Rennes, 35033, France

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Università degli Studi di Parma

    Parma, Italy

  • Universitätsklinikum Münster Medizinische Klinik A, Hämatologie, Hämostaseologi

    Münster, Germany

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Victoria Cancer Care Center

    Parkville, Victoria, 3000, Australia

  • Yale University

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.