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New treatment option for AML (Acute Myelogenous Leukemia)
Official title Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT
ClinicalTrials.gov ID: NCT06783790
What this study is testing
What is Avapritinib, azacitidine, Venetoclax?
Avapritinib, azacitidine, Venetoclax is an investigational medicine, being studied as a potential treatment for aml (acute myelogenous leukemia).
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-center, prospective, single-arm, exploratory clinical study. To explore the efficacy and safety of avapritinib in patients with recurrent acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation with C-KIT mutation RUNX1::RUNX1T1 or CBFB::MYH11.
- 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
- people met the criteria for recurrence after allogeneic transplantation: re-emergence of leukemia cells or bone marrow original cells in peripheral...
- Bone marrow molecular biology detected C-KIT D816 or C-KIT N822 mutations
- Patients with CBFB::MYH11 gene or RUNX1::RUNX1T1 fusion gene detected.
- Eastern Cancer Collaboration Group (ECOG) physical status score 0-2 points.
- Liver, kidney and cardiopulmonary functions met the following requirements: Within 2 weeks before enrollment ① creatinine ≤1.5 upper limit of normal...
You likely can't join if
- Known allergy to KIT inhibitor drug analogues.
- Patients who have received previous treatment with Midostaurin.
- Patients who have previously been treated with mutation-specific C-KIT inhibitors and have developed disease progression during treatment.
- FLT3-ITD mutation in patients with recurrent/refractory disease (except low gene ratio).
- HIV infected persons, HBV, HCV active infected persons.
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious...
See the full eligibility criteria
- people met the criteria for recurrence after allogeneic transplantation: re-emergence of leukemia cells or bone marrow original cells in peripheral blood \>5% (except for other causes such as bone marrow recovery...
- Bone marrow molecular biology detected C-KIT D816 or C-KIT N822 mutations
- Patients with CBFB::MYH11 gene or RUNX1::RUNX1T1 fusion gene detected.
- Eastern Cancer Collaboration Group (ECOG) physical status score 0-2 points.
- Liver, kidney and cardiopulmonary functions met the following requirements: Within 2 weeks before enrollment ① creatinine ≤1.5 upper limit of normal value; ② Left ventricular ejection fraction ≥50%; ③ Blood oxygen...
- Volunteer to participate in clinical studies and sign informed consent, willing to follow and able to complete all trial procedures.
- Known allergy to KIT inhibitor drug analogues.
- Patients who have received previous treatment with Midostaurin.
- Patients who have previously been treated with mutation-specific C-KIT inhibitors and have developed disease progression during treatment.
- FLT3-ITD mutation in patients with recurrent/refractory disease (except low gene ratio).
- HIV infected persons, HBV, HCV active infected persons.
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.
- With uncontrolled active GVHD (NIH for GVHD diagnosis and classification standards, aGVHD classification refer to the improved Glucksberg standard).
- Central nervous system leukemia.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, 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 Tianjin, 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.