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Tests treatment safety and results for AML, Childhood
Official title Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation
ClinicalTrials.gov ID: NCT06316960
What this study is testing
What is Avapritinib?
Avapritinib is an investigational medicine, being studied as a potential treatment for aml, childhood.
Also referred to as AYVAKIT.
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 purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.
- 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 up to 18
You may be able to join if
- Gender unlimited;
- Under 18 years;
- Diagnosis of acute myeloid leukemia (according to the 2022 WHO classification).
- Presence of t(8;21)/RUNX1::RUNX1T1 or inv(16)/t(16;16)/CBFβ::MYH11;
- KIT mutation;
You likely can't join if
- Have received prior treatment with avapritinib;
- Receiving other targeted therapies for AML at the same time, such as dasatinib, sorafenib, gilteritinib, venetoclax, etc;
- Presence of active uncontrolled infection (including bacterial, fungal, or viral infection);
- Present of significant underlying organ diseases: such as myocardial infarction, chronic heart failure, decompensated liver or kidney dysfunction；
- With other malignancies requiring treatment；
- Already enrolled in another treatment clinical study；
See the full eligibility criteria
- Gender unlimited;
- Under 18 years;
- Diagnosis of acute myeloid leukemia (according to the 2022 WHO classification).
- Presence of t(8;21)/RUNX1::RUNX1T1 or inv(16)/t(16;16)/CBFβ::MYH11;
- KIT mutation;
- Refractory AML: AML patients who do not achieve CR or CRi after induction therapy;
- Relapsed AML: patients who achieved remission after consolidation therapy or transplantation, FISH confirmed that the fusion gene turned positive, or extramedullary leukemia infiltration;
- No active infections;
- Liver function: Tbil ≤2×ULN, ALT/AST ≤3×ULN, creatinine clearance ≥50ml/min;
- ECOG score \<2;
- Expected survival time \>12 weeks;
- Participants must have the ability to understand and be willing to participate in this study and must sign an informed consent form.
- Have received prior treatment with avapritinib;
- Receiving other targeted therapies for AML at the same time, such as dasatinib, sorafenib, gilteritinib, venetoclax, etc;
- Presence of active uncontrolled infection (including bacterial, fungal, or viral infection);
- Present of significant underlying organ diseases: such as myocardial infarction, chronic heart failure, decompensated liver or kidney dysfunction；
- With other malignancies requiring treatment；
- Already enrolled in another treatment clinical study；
- The researchers determined that the individual is not suitable to participate in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Kaifeng, Henan, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Suzhou, Jiangsu, China
- Xuzhou, Jiangsu, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, 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, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Kaifeng, Henan, China; Zhengzhou, Henan, China; Changsha, Hunan, China and 4 more location(s). 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.