A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia (NCT07392242)
A Phase II Study of IDH1 Inhibition With Ivosidenib as Maintenance Therapy After Ivosidenib, Azacitidine, and Venetoclax for Acute Myeloid Leukemia
🩺 Plain-English Summary (8th-Grade Level)
The researchers are doing this study to find out whether a 3-drug combination of ivosidenib, azacitidine, and venetoclax followed by maintenance therapy with ivosidenib alone is an effective treatment approach for people with newly diagnosed acute myeloid leukemia (AML) that has an IDH mutation. Maintenance therapy is additional treatment given to help keep cancer from coming back after it has disappeared following the first course of treatment. The researchers will also look at the safety of the treatment approach and what kind of a time commitment it involves for participants.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (12 items).
Location: Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
Age range: 60 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participant with acute promyelocytic leukemia
- Participants who have previously received ivosidenib or venetoclax
- Participant receiving any other investigational anti-cancer agents. Cytoreductive therapy such as hydroxyurea is permitted.
- Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
- Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).
- Participants who are planned for allogeneic stem cell transplantation based on the assessment of the treating clinician.
- Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and/or stroke
- Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). As per exclusion criteria 5, patients receiving appropriate treatment would only be excluded if there is no improvement.
- Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
- Participant has QTc interval (i.e., Fridericia's correction \[QTcF\]) ≥ 450 ms (mean of triplicate ECG) or other factors that increase the risk of QT prolongation or ventricular arrhythmic events (e.g. family history of long QT interval syndrome). Participants with a QTcF over 450 ms due
- Male or female participants not willing to comply with contraceptive requirements
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (7 Sites)
- Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) — Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York
📞 Contact the Study Coordinator
Phone: (646) 608-4415
Email: chin3@mskcc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Acute Myeloid Leukemia
- PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS — Tampa, Florida
- ONC-LEUK-2406: The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia — Charlotte, North Carolina
- Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT — Tampa, Florida
- Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy — Little Rock, Arkansas
- A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML — Phoenix, Arizona
Explore by condition: All Acute Myeloid Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.