Actively Recruiting
Ivosidenib Combined With Venetoclax and Azacitidine for Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia: A Single-arm, Two-cohort Study
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-06-06
42
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment using ivosidenib, venetoclax, and azacitidine in adult Chinese patients newly diagnosed with IDH1 mutation acute myeloid leukemia (AML). This phase 2, single-arm, open-label trial involves about 42 participants across multiple centers in China. The study aims to measure how well this combination induces complete remission and partial hematologic recovery, along with other outcomes like event-free survival and overall survival. Participants receive combination therapy in two groups: those considered fit and those unfit for intensive treatment. Ivosidenib is taken orally daily starting from day 15 of the first 28-day cycle and continues daily thereafter. Venetoclax is given orally with a dose escalation in the first cycle and then daily for 14 days of each subsequent cycle. Azacitidine is administered by injection daily for seven days in each 28-day cycle. Fit participants undergo at least 2 cycles, while unfit participants receive a minimum of 6 cycles unless certain conditions like relapse, disease progression, unacceptable side effects, pregnancy, withdrawal, or study completion occur. Throughout the trial, participants will be monitored regularly to assess treatment response, including complete remission rates at one year, event-free survival, overall survival, and objective response rates. Blood and bone marrow samples will be collected periodically. Participants will also complete quality of life assessments during and after treatment. The study includes safety monitoring and requires informed consent, with careful follow-up to evaluate the treatment's effects over time.
CONDITIONS
Brief Title
a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older
- Have untreated acute myeloid leukemia diagnosed by World Health Organization criteria
- Have an IDH1 mutation with R132C, R132G, R132H, R132L, or R132S substitution
- Have an ECOG performance status of 0 to 2
- Have adequate liver function with bilirubin and liver enzymes below specified limits
- Have adequate kidney function with creatinine or clearance above specified limits
- Agree to provide serial blood and bone marrow samples
- Be able to understand and sign informed consent
- Willing to complete quality of life assessments during and after treatment
- If female with reproductive potential, have a negative pregnancy test and agree to use effective contraception
You will not qualify if you...
- Have received prior AML treatment except for hydroxyurea or leukapheresis
- Have received hypomethylating agents for myelodysplastic syndrome
- Have favorable risk cytogenetics such as t(8;21), inv(16), t(16;16), or t(15;17)
- Have acute promyelocytic leukemia
- Received prior treatment for antecedent hematologic disorder without required washout
- Received prior IDH1 or BCL-2 inhibitors
- Known allergy to ivosidenib, venetoclax, or azacitidine components
- Are pregnant or breastfeeding
- Taking strong CYP3A4 inducers or sensitive CYP3A4 substrate medications unless switched
- Have uncontrolled active infections despite treatment
- History of malignancy other than MDS or myeloproliferative disorder within past year
- Significant active cardiac disease within last 6 months
- Prolonged QT interval or risk factors for arrhythmia unless properly monitored
- Known uncontrolled HIV, hepatitis B or C infection
- Conditions limiting oral drug absorption
- Uncontrolled hypertension
- Active or suspected central nervous system leukemia
- Immediate life-threatening leukemia complications
- Medical or psychological conditions interfering with consent or participation
- Taking medications known to prolong QT interval without proper management
- History of progressive multifocal leukoencephalopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 2 to 6 cycles of 28 days each depending on fitness and response
Participants receive combination therapy with ivosidenib, venetoclax, and azacitidine. Treatment cycles last 28 days each, with oral ivosidenib starting on Day 15 of Cycle 1 and continued daily thereafter, venetoclax given orally with a ramp-up dosing in Cycle 1 and continued on Days 1-14 in subsequent cycles, and azacitidine administered by injection during the first week of each cycle. Unfit participants are treated for a minimum of 6 cycles and fit participants for at least 2 cycles, depending on response and tolerability.
Multiple visits each cycle including daily oral dosing and injections in the first week
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Su-ning Chen, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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