Recruiting PHASE2 Acute Myeloid Leukemia

New treatment option for Acute Myeloid Leukemia

Official title a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia

ClinicalTrials.gov ID: NCT07007949

What this study is testing

What is Ivosidenib combined with venetoclax and azacitidine?

Ivosidenib combined with venetoclax and azacitidine is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for acute myeloid leukemia.

Also referred to as Unfit Arm.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: This is a single arm, open-label, multicenter clinical trial to evaluate the efficacy and safety of ivosidenib+venetoclax+ azacitidine in adult Chinese subjects with newly diagnosed IDH1m AML.A total of approximately 42 China Nationwide subjects with newly diagnosed IDH1m AML will participate in the study.The primary endpoint of the study is the complete remission(CR) + CR with partial hematologic recovery(CRh) rate, and the key secondary endpoints are CR rate,event-free survival (EFS),overall survival (OS),the objective response rate (ORR).

Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

Be ≥18 years of age
Have previously untreated AML, defined according to World Health Organization criteria. people with extramedullary disease alone (ie, no detectable...
Have an IDHl mutation resulting in an R132C, R132G, R132H, R132L, or R132S substitution.
Have an ECOG PS score of 0 to 2.
Have adequate hepatic function, as evidenced by:

You likely can't join if

Have received any prior treatment for AML with the exception of nononcolytic treatments to stabilize disease such as hydroxyurea or leukapheresis.
Have received a hypomethylating agent for myelodysplastic syndrome (MDS).
Subject has favorable risk cytogenetics such as t(8;21), inv(16), t(16;16) or t(15;17).
Subject has acute promyelocytic leukemia
people who had previously received treatment for an antecedent hematologic disorder, including investigational agents, may not be assigned by chance...
Have received prior treatment with an IDH1 inhibitor or BCL-2 inhibitor.

See the full eligibility criteria

Who can join

Be ≥18 years of age
Have previously untreated AML, defined according to World Health Organization criteria. people with extramedullary disease alone (ie, no detectable bone marrow and no detectable peripheral blood AML) are not eligible...
Have an IDHl mutation resulting in an R132C, R132G, R132H, R132L, or R132S substitution.
Have an ECOG PS score of 0 to 2.
Have adequate hepatic function, as evidenced by:
Serum total bilirubin ≤2 × ULN, unless considered to be due to Gilbert's disease or underlying leukemia, where it must be \<3 x ULN.
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3.0 × ULN, unless considered to be due to underlying leukemia.
Have adequate renal function, as evidenced by serum creatinine ≤2.0 x ULN or creatinine clearance \>30 mL/min based on the Cockcroft-Gault glomerular filtration rate.
Have agreed to undergo serial blood and bone marrow sampling.
Be able to understand and willing to sign an informed consent form.
Be willing to complete QoL assessments during study treatment and at the designated time points following treatment discontinuation.
If female with reproductive potential, must have a negative serum pregnancy test prior to the start of study therapy. Female people with reproductive potential are defined as sexually mature women who have not undergone...

What rules you out

Have received any prior treatment for AML with the exception of nononcolytic treatments to stabilize disease such as hydroxyurea or leukapheresis.
Have received a hypomethylating agent for myelodysplastic syndrome (MDS).
Subject has favorable risk cytogenetics such as t(8;21), inv(16), t(16;16) or t(15;17).
Subject has acute promyelocytic leukemia
people who had previously received treatment for an antecedent hematologic disorder, including investigational agents, may not be assigned by chance until a washout period of at least 5 half-lives of the investigational...
Have received prior treatment with an IDH1 inhibitor or BCL-2 inhibitor.
Have a known hypersensitivity to any of the components of Ivosidenib, venetoclax, or azacitidine.
Are female and pregnant or breastfeeding.
Are taking known strong cytochrome P450 (CYP) 3A4 inducers or sensitive CYP3А4 substrate medications with a narrow therapeutic window, unless they can be transferred to other medications within ≥5 half-lives prior to...
Have an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
Have a prior history of malignancy other than MDS or myeloproliferative disorder, unless the subject has been free of the disease for ≥1 year prior to the start of study treatment. However, people with the following...
Basal or squamous cell carcinoma of the skin
Carcinoma in situ of the cervix
Have had significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association Class (NYHA) Class III or IV congestive heart failure, myocardial infarction...
Have a heart-rate corrected QT interval using Fridericia's method (QTcF) \>470 msec or any other factor that increases the risk of QT prolongation or arrhythmic events (eg, NYHA Class III or IV congestive heart failure...
Have a known infection caused by human immunodeficiency virus or active hepatitis B virus (HBV) or hepatitis C virus that cannot be controlled by treatment.
Have dysphagia, short-gut syndrome, gastroparesis, or any other condition that limits the ingestion or gastrointestinal absorption of orally administered drugs.
Have uncontrolled hypertension (systolic blood pressure [BP] \>180 mmHg or diastolic BP\>100 mmHg).
Have clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid during Screening is only required if there is a clinical suspicion of CNS...
Have immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or disseminated intravascular coagulation.
Have any other medical or psychological condition deemed by the Investigator to be likely to interfere with the subject's ability to give informed consent or participate in the study.
Are taking medications that are known to prolong the QT interval unless they can be transferred to other medications within ≥5 half-lives prior to dosing, or unless the medications can be properly monitored during the...
people with a known medical history of progressive multifocal leukoencephalopathy.

The study team makes the final eligibility decision.

Where it's taking place

Suzhou, Jiangsu, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.