Actively Recruiting
A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-06
45
Participants Needed
7
Research Sites
100 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
S
Servier Pharmaceuticals, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be at least 60 years of age at the time of signing the informed consent form (ICF).
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
- Participant has newly diagnosed AML as per World Health Organization 2022 or European leukemia Network 2022 guidelines.
- Participant has IDH1-R132 mutation present prior to initiating Ivo/Aza/Ven confirmed by CLIA approved local testing via next-generation sequencing (NGS) and/or polymerase chain reaction (PCR).
- Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Participant must have a WBC count <25,000/µL at the time of initiation of study drug.
- Participant has adequate organ function defined by specific liver and kidney function criteria.
You will not qualify if you...
- 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.
- Participants who are planned for allogeneic stem cell transplantation.
- Participant has significant active cardiac disease within 6 months prior to start of study treatment.
- Participant has active viral infection with HIV, HBV, or HCV without improvement despite treatment.
- Participant has conditions limiting oral drug absorption such as dysphagia, short-gut syndrome, or gastroparesis.
- Participant has QTc interval ≥ 450 ms or other factors increasing risk of QT prolongation.
- Male or female participants not willing to comply with contraceptive requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
K
Kuo-Kai Chin, MD
CONTACT
E
Eytan Stein, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here