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New combo therapy targets genetic weakness in Hard-to-Treat leukemia

NCT ID NCT02677922

Disease control Sponsor: Celgene 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests two experimental drugs (AG-120 and AG-221) that target specific genetic mutations (IDH1 or IDH2) found in some acute myeloid leukemia (AML) patients. Each drug is combined with a standard chemotherapy (azacitidine) and compared to azacitidine alone. The trial enrolls 130 newly diagnosed AML patients who cannot tolerate intensive chemotherapy. The goal is to find the safest and most effective dose and see if the combinations improve response rates.

What this could mean

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

Active substance
AG-120 (ivosidenib) or AG-221 (enasidenib) plus azacitidine
What this could lead to
If successful, this could provide a more effective, less intensive treatment option for older or frail patients with a specific genetic subtype of AML.
What could go wrong
This is an early-phase trial (1b/2) with a small number of participants, so results may not confirm benefit. Side effects from the drug combinations could be serious.

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

130 people

The number who actually took part.

Started

Jun 2016

Expected to finish

Sep 2026

An estimate. End dates often move.

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: * 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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia leukemia

As listed by the trial registrant

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

Leukemia, myeloid, acute

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115, United States

  • Local Institution - 102

    Boston, Massachusetts, 02114, United States

  • Local Institution - 103

    Chicago, Illinois, 60637, United States

  • Local Institution - 105

    Duarte, California, 91010-301, United States

  • Local Institution - 106

    New York, New York, 10065, United States

  • Local Institution - 107

    New Haven, Connecticut, 06510, United States

  • Local Institution - 108

    Chicago, Illinois, 60611, United States

  • Local Institution - 110

    Dallas, Texas, 75390-85520, United States

  • Local Institution - 125

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 175

    Melbourne, 3141, Australia

  • Local Institution - 177

    Perth, 6000, Australia

  • Local Institution - 178

    Adelaide, South Australia, SA 5000, Australia

  • Local Institution - 200

    Paris, 75475, France

  • Local Institution - 201

    Villejuif, 94805, France

  • Local Institution - 202

    Pierre-Bénite, 69495, France

  • Local Institution - 203

    Toulouse, 31059, France

  • Local Institution - 204

    Pessac, 33604, France

  • Local Institution - 205

    Lille, 59037, France

  • Local Institution - 206

    Marseille, 13273, France

  • Local Institution - 225

    Ulm, 89081, Germany

  • Local Institution - 227

    Berlin, 12200, Germany

  • Local Institution - 230

    Dresden, 01307, Germany

  • Local Institution - 250

    Pesaro, 31122, Italy

  • Local Institution - 251

    Orbassano, 10043, Italy

  • Local Institution - 252

    Florence, 50134, Italy

  • Local Institution - 253

    Bologna, Emilia-Romagna, 40138, Italy

  • Local Institution - 254

    Padova, 35128, Italy

  • Local Institution - 255

    Roma, 00189, Italy

  • Local Institution - 256

    Genova, 16132, Italy

  • Local Institution - 277

    Utrecht, 3584 CX, Netherlands

  • Local Institution - 327

    Lisbon, 1169-050, Portugal

  • Local Institution - 350

    Seoul, 138-736, South Korea

  • Local Institution - 351

    Seoul, 135-710, South Korea

  • Local Institution - 375

    Barcelona, 08907, Spain

  • Local Institution - 376

    Cáceres, 10005, Spain

  • Local Institution - 377

    Valencia, 46009, Spain

  • Local Institution - 378

    Madrid, 28007, Spain

  • Local Institution - 379

    Barcelona, 08036, Spain

  • Local Institution - 380

    Málaga, 29010, Spain

  • Local Institution - 381

    Madrid, 28033, Spain

  • Local Institution - 401

    Zurich, 0, Switzerland

  • Local Institution - 403

    Basel, 4031, Switzerland

  • Local Institution - 427

    Headington, OX3 9DU, United Kingdom

  • Local Institution - 428

    London, SE5 9RS, United Kingdom

  • Local Institution - 429

    Birmingham, B15 2TH, United Kingdom

  • Local Institution - 430

    Sutton (Surrey), SM2 5PT, United Kingdom

  • Local Institution - 902

    Boston, Massachusetts, 02115, United States

  • Local Institution - UNK-121

    Yvoir, 5530, Belgium

  • Local Institution - UNK-52

    Gothenburg, 413 45, Sweden

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