RecruitingPhase 1

Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation

Olutasidenib Single Agent as Maintenance Therapy in IDH1mut AML After Induction and Consolidation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Up to 15 participants will receive treatment with olutasidenib 150 mg by mouth twice daily for up to 2 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests olutasidenib alone or with other treatment in adults with acute myeloid leukemia (AML), a blood cancer, with a change in the IDH1 gene. It is for people who have finished intensive starting treatment. Researchers want to learn if it is safe and may help keep the cancer from returning and help people live longer.

Treatment with olutasidenib for isocitrate dehydrogenase 1 (IDH1) mutant acute myeloid leukemia (AML) after completion of traditional intensive induction/consolidation is likely to be safe, tolerable, and may provide clinical benefit in terms of maintenance of remission and perhaps improvement in survival.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with confirmed AML that has an IDH1 gene change. A type called acute promyelocytic leukemia is not included.
  • Have finished initial treatment to clear the leukemia, with or without follow-up treatment. Tests must show a study-allowed response, even if blood counts have not fully recovered. Start within 90 days of your last treatment cycle.
  • Have a kidney filtering test result of at least 30 mL/min.
  • Have liver blood tests within study limits: bilirubin no more than 2 times normal and AST/ALT no more than 3 times normal. Different bilirubin limits apply to people with Gilbert's syndrome.
  • Meet the study's limits for daily activity and self-care: ECOG score 0–2 or KPS score above 50%.
  • Be able to take medicine by mouth.
  • Women who can become pregnant must agree to effective birth control during treatment and for at least 6 months after the last dose.
  • Men who have not had a vasectomy and have sex with women who can become pregnant must use barrier birth control and avoid sperm donation during treatment and for 90 days afterward.

Who can't join

  • Have an allergy to olutasidenib or its ingredients, a QTc heart rhythm test above 450 milliseconds after correction, or a history of the dangerous heart rhythm called Torsades de Pointes.
  • Have a gut condition that may keep your body from taking in the medicine, or be eligible for and planning a stem cell transplant within 60 days of starting the study.
  • Have an uncontrolled illness or infection, or a medical, mental health, or social issue that may make the study unsafe or hard to follow. Controlled HIV, hepatitis, and other long-term infections are allowed.
  • Be pregnant, breastfeeding, unwilling to use required birth control, or planning to donate eggs during treatment or for 6 months afterward. Men cannot plan sperm donation during treatment or for 3 months afterward.
  • Take medicines that could cause unsafe interactions with olutasidenib, including some heart rhythm medicines, or receive chemotherapy for another cancer that could interfere with study treatment.
  • Have received lower-intensity starting treatment, including hypomethylating drugs or venetoclax-based treatment, or currently take other targeted or AML treatments.
  • Have received another study drug in a clinical trial within 4 weeks before joining.
  • Take steroid medicines above 10 mg of prednisone a day or an equal dose of another steroid, unless treating IDH differentiation syndrome, a treatment reaction, or allowed by a stated study exception.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Histologically or cytologically confirmed non-acute promyelocytic isocitrate dehydrogenase (1 IDH1) mutant acute myeloid leukemia (AML). IDH1 mutation may be identified by NGS or PCR based methods and identified at time of diagnosis or any other time point prior to enrollment. * Completed induction and/or consolidation intended as per treating physician to reach complete response (CR),complete response with partial hematologic recovery (CRh), or complete response with incomplete hematologic recovery (CRi), or morphologic leukemia free state (MLFS) at time of study enrollment Patients must be within 90 days of their last cycle of upfront therapy. * Age ≥18 years * Calculated creatinine clearance (by Cockroft-Gault) ≥30 mL/min * Total bilirubin ≤2 × upper limit of normal (ULN) Note: patients with Gilbert's syndrome may be included if total bilirubin is ≤3 × ULN and direct bilirubin is ≤2 × ULN * Serum aspartate aminotransferase/ alanine aminotransferase (AST/ALT) ≤3 × ULN * Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2 or KPS \>50% * Able to take oral medications * Women of childbearing potential must consent to effective contraception during study treatment and at least 6 months following the last dose. Effective methods of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double- barrier methods. (ie, combination of male condom with either cap, diaphragm or sponge with spermicide) * Male participants who are sexually active with a woman of childbearing potential and who have not had vasectomies must be willing to use a barrier method of contraception and refrain from sperm donation from initial study drug until 90 days after last dose of study drug. Exclusion Criteria: * History of hypersensitivity or allergic reaction to olutasidenib or its components * Corrected Q-T interval (QTc) (Fredericia calculation) \> 450 ms (after corrective action is taken) * History of Torsades de Pointes * Any gastrointestinal condition thought by the treating investigator to impair oral absorption of medication * Stem cell transplant eligible and planned within 60 days of study start date in the opinion of the treating investigator * Uncontrolled intercurrent illness or infection (those with controlled human immunodeficiency virus (HIV), hepatitis, or other chronic infections are eligible) * Female participants who are pregnant or intend to donate eggs during the study or for 6 months after receiving their last dose of study drug * Nursing women, women of childbearing potential with positive pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. (Appropriate method(s) of contraception include oral or injectable hormonal birth control, IUD, and double-barrier methods) * Male participants who intend to donate sperm during the course of this study or for 3 months after last dose * Participants receiving, or are expected to require during the study, any concomitant medications that may interfere with efficacy, metabolism, or safety of the investigational agent, including drugs known to cause QT prolongation. for which drug interactions with olutasidenib would be prohibitory * Concurrent chemotherapy for non-AML malignancy that is expected to interfere with the efficacy, metabolism, or safety of the agent under investigation * Received non-intensive upfront therapy including hypomethylating agents (HMA) /Venetoclax based * Currently receiving other targeted therapies or AML directed therapies, including but not limited to other IDH1 or IDH2 inhibitors, FMS-like tyrosine kinase 3 (FLT3) inhibitors, B-cell lymphoma 2 (BCL-2) inhibitors, menin inhibitors * Other investigational agents in another clinical trial within 4 weeks prior to enrollment * Systemic corticosteroids above physiologic replacement doses (10mg/day prednisone or equivalent), unless used to tread IDH differentiation syndrome or as part of a pre-specified protocol exception * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk or limit the participant's adherence with study requirements

Study sites (1)

VA