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Recruiting NCT07392242

A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia

Conditions: Acute Myeloid Leukemia

Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 45
Sponsor: Memorial Sloan Kettering Cancer Center

Location: Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey

Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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). Other 2-HG producing IDH1 variants may be eligible after discussion with MSK principal investigator. 1. At MSK, this testing will utilize the MSK-REACT, a rapid multi-gene NGS panel used in all new AML diagnoses that is clinically validated by the Laboratory of Diagnostic Molecular Pathology pursuant to the requirements of CLIA'88 and approved by New York State. Other sites may use local CLIA-certified laboratories and validated clinical assays as per standard of care. 2. The patient's chart will be utilized for screening purposes * Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 * Participant must have a WBC count \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07392242). StuddyBuddy aggregates publicly available trial information.