A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia
Recruiting
Phase 1
Phase 2
Interventional Study
Acute Myeloid Leukemia With T(8;21)(Q22;Q22)
Acute Myeloid Leukemia With T(16;16)(P13;Q22)
KIT Gene Mutation
Avapritinib
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 78 (estimated)
- Sponsor
- The First Affiliated Hospital of Soochow University · Other
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About This Trial
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. The main questions it aims to answer are:
To determine th…
Trial Locations
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Eligibility Criteria
Inclusion 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:…
Contacts