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A multicenter clinical trial of copy number variation (CNA) affecting the prognosis of elderly patients with intermediate-risk acute myeloid leukemia (AML)

A multicenter clinical trial of copy number variation (CNA) affecting the prognosis of elderly patients with intermediate-risk acute myeloid leukemia (AML)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062311
Enrollment
Unknown
Registered
2022-08-01
Start date
2022-07-20
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia (AML)

Interventions

case series:None

Sponsors

The Affiliated Cancer Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Newly diagnosed AML (non-APL) patients who meet the WHO 2016 diagnostic criteria; (2) Patients' age between 60 and 75 years, male or female; (3) Patients with intermediate-risk related genetic and molecular variants consistent with 2017 ELN stratification; (4) The patient has obtained gene mutation detection results based on next-generation sequencing, including but not limited to FLT3-ITD, NPM1, CEBPA, TP53, RUNX1, ASXL1, IDH1, IDH2, DNMT3a, C-kit or other gene mutations; (5) The patient has obtained fusion gene test results, including but not limited to PML-RARa, RUNX1-RUNX1T1, CBFß-MYH11, MLLT3-KMT2A, MLL rearrangement, BCR-ABL1, DEK-NUP214 or other fusion genes; (6) Patients with physical fitness score 0-3 (WHO standard); (7) Patients with normal liver and kidney functions: blood bilirubin <= 35µmol/L, AST/ALT below 2 times the upper limit of normal range and serum creatinine <= 150µmol/L; (8) Patients with normal cardiac function.

Exclusion criteria

Exclusion criteria: (1) AML patients who are not innitially-diagnosed; (2) Patients' age less than 60 years old or more than 75 years old; (3) Patients with low-risk or high-risk genetic and molecular variants consistent with 2017 ELN stratification; (4) Gene mutation detection or fusion gene detection was not performed at the initial diagnosis; (5) Patients who plan to undergo allogeneic hematopoietic stem cell transplantation; (6) Patients with a definite diagnosis of central nervous system involvement; (7) Women who are pregnant, planning to become pregnant or breastfeeding; (8) Patients with other malignant tumors who need treatment; (9) Active TB patients and HIV-positive patients; (10) Patients with drug addiction or mental illness; (11) Patients with obvious abnormal liver and kidney function, exceeding the inclusion criteria; (12) Patients with serious heart disease, including myocardial infarction and cardiac insufficiency; (13) ECG result: QT interval greater than 450 ms; (14) The patient with unqualified sample.

Design outcomes

Primary

MeasureTime frame
Copy number aberration(CNA);

Countries

China

Contacts

Public ContactSong Yongping
songyongping001@126.com+86 13803846526

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026