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New treatment option for Acute Myeloid Leukemia With T(8;21)(Q22;Q22)
Official title A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT07028073
What this study is testing
What is Group A (FIT): Avapritinib + IA regimen?
Group A (FIT): Avapritinib + IA regimen is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia with t(8;21)(q22;q22).
Also referred to as Group A (Intensive chemotherapy).
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
- The goal of this clinical trial is to learn if avapritinib combined with standard induction therapy works to treat newly diagnosed adult acute myeloid leukemia (AML) patients with KIT mutations and t(8;21)(q22;q22.1); inv(16)(p13.1q22) or t(16;16)(p13.1;q22). It will also investigate the safety and tolerability of this combination therapy.
- Phase 2: a mid-size study of how well it works
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
- Age ≥18 years, both genders
- Diagnosis of acute myeloid leukemia according to WHO 2022 criteria
- Treatment-naive patients (hydroxyurea or low-dose cytarabine \<0.5g cumulative dose allowed)
- Bone marrow detection of KIT mutations with concurrent t(8;21)(q22;q22.1) or RUNX1::RUNX1T1 fusion gene; or inv(16)(p13.1q22) or t(16;16)(p13.1;q22)...
- Life expectancy \>12 weeks Group A: ≥18 and \<65 years with ECOG 0-1; Group B: ≥65 years or ≥18 and \<65 years with comorbidities (ECOG ≥2, cardiac...
You likely can't join if
- Known hypersensitivity to KIT inhibitors, cytarabine, idarubicin, venetoclax, azacitidine or similar agents
- Concurrent use of other KIT inhibitors (dasatinib, sorafenib, gilteritinib, midostaurin)
- Intracranial hemorrhage on imaging or unresolved prior intracranial bleeding
- Active uncontrolled infection
- Significant organ dysfunction: myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal failure
- Pregnancy or breastfeeding
See the full eligibility criteria
- Age ≥18 years, both genders
- Diagnosis of acute myeloid leukemia according to WHO 2022 criteria
- Treatment-naive patients (hydroxyurea or low-dose cytarabine \<0.5g cumulative dose allowed)
- Bone marrow detection of KIT mutations with concurrent t(8;21)(q22;q22.1) or RUNX1::RUNX1T1 fusion gene; or inv(16)(p13.1q22) or t(16;16)(p13.1;q22) or CBFβ::MYH11 fusion gene
- Life expectancy \>12 weeks Group A: ≥18 and \<65 years with ECOG 0-1; Group B: ≥65 years or ≥18 and \<65 years with comorbidities (ECOG ≥2, cardiac disease, creatinine clearance 30-50ml/min, or mild hepatic impairment)
- Adequate organ function: bilirubin ≤2×ULN, ALT/AST ≤3×ULN (≤5×ULN if leukemic infiltration), creatinine clearance ≥30ml/min, left ventricular ejection fraction \>45%
- Known hypersensitivity to KIT inhibitors, cytarabine, idarubicin, venetoclax, azacitidine or similar agents
- Concurrent use of other KIT inhibitors (dasatinib, sorafenib, gilteritinib, midostaurin)
- Intracranial hemorrhage on imaging or unresolved prior intracranial bleeding
- Active uncontrolled infection
- Significant organ dysfunction: myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal failure
- Pregnancy or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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.
Explore other conditions
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.