The Efficacy of Allo-HSCT in ND HR-CBF-AML (NCT06458244) | Clinical Trial Compass
RecruitingNot Applicable
The Efficacy of Allo-HSCT in ND HR-CBF-AML
China90 participantsStarted 2024-09-21
Plain-language summary
For newly diagnosed high-relapse-risk core-binding-factor acute myeloid leukemia participants, the investigators aim to perform allogeneic hematopoietic stem cell transplantation after participants finished one cycle of induction and two cycles of consolidation. To access whether the therapeutic regimen is effective for high-relapse-risk core-binding-factor acute myeloid leukemia, the disease-free-survival (DFS), overall survival (OS), non-relapse-mortality of participants is evaluated.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Participants with confirmed CBF-AML. Diagnostic criteria include the presence of t(8; 21)(q22; q22)/RUNX1-RUNX1T1 fusion gene detected at the molecular level; or chromosome presence of inv(16)(p13.1q22)/t(16; 16)(p13.1; q22) /Detection of CBFβ-MYH11 fusion gene at the molecular level;
✓. Participants with high-risk gene mutations or complex karyotypes for disease recurrence, or flow cytometry/gene MRD positivity after two chemotherapy treatments; High-risk gene mutations include: TP53, RTK/RAS signaling (FLT3, NRAS, KRAS, KIT, JAK2, CSF3R), chromatin modification (ASXL1, ASXL2, KMD6A, EZH2, SETD2) or mutations listed as intermediate-risk or high-risk in the 2022NCCN guidelines; The positive threshold for flow cytometry MRD was 0.0001%; The MRD threshold of molecular biology is the lowest value of the detection protocol of the center.
Exclusion criteria
✕. Age 18-65 years old (18 years old ≤Age\< 65 years old);
✕. Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal, serum creatinine ≤ 150 μmol/L;
✕. Normal cardiac function (EF≥50%, New York Cardiac Function Classification NYHA I/II);
✕. Physical condition score 0-2 (ECOG score);
✕. For participants with peripheral blood leukocytes \< 50\*109/L at the initial onset, no chemotherapy has been given except for hydroxyurea before the start of induction therapy;
✕. For participants with peripheral blood leukocytes ≥ 50\*109/L at the initial onset, cytarabine and hydroxyurea are allowed to be treated before the start of induction therapy;
What they're measuring
1
disease-free-survival
Timeframe: from data of AML diagnosis until the data of AML relapse, assessed up to 3 years
2
The relation of CBF-AML genetics subgroup with MRD negativity rate after chemotherapy and DFS after transplantation
Timeframe: from data of AML diagnosis until the data of CR-achieved status, assessed up to 3 years