Skip to content

A multicenter clinical trial of minimal residual disease (MRD) detection by the Next generation Sequencing (NGS) technique in newly diagnostic acute myeloid leukemia (AML) patients

A multicenter clinical trial of the detection of minimal residual disease (MRD) in newly diagnostic acute myeloid leukemia (AML) by the Next generation Sequencing (NGS) technique

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ROC-17012585
Enrollment
Unknown
Registered
2017-09-05
Start date
2017-09-18
Completion date
Unknown
Last updated
2017-09-11

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

No grouping:Bone marrow and oral mucosa cells

Sponsors

Institute of Hematology and Oncology of Harbin First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed AML patient with negative fusion genes and positive mutant genes (excluding APL); 2. Aged 18 to 65 years old, male or female; 3. And the normal function of liver and kidney: blood bilirubin: less than or equal to 35 mu; mol/L, AST/ALT,below the normal value limit of 2 times, less than or equal to 150 mu mol/L; 4. cardiac function is normal; 5. Performance status 0-3 (WHO standard); 6. Obtain informed consent signed by the patient or his family members.

Exclusion criteria

Exclusion criteria: 1. non newly diagnosed AML patients; 2. newly diagnosed AML patient with positive fusion genes; 3. newly diagnosed AML patient with negative mutant genes; 4. identify patients with central nervous system invasion; 5. Abnormal liver and kidney function, standard of over access group patients; 6. serious heart disease including myocardial infarction and cardiac insufficiency; 7. ECG results: QT interval is greater than 450 ms; 8. suffering from other malignant tumors of the viscera; 9. patientstive with active TB and HIV positive; 10. inability to understand or comply with research programmes; 11. Pregnant or lactating women; 12. There is drug addiction or mental illness; 13. participated in other clinical studies during the same period; 14. there are other conditions that hinder research; 15. patients who are ready for transplantation.

Design outcomes

Primary

MeasureTime frame
Variable Allele Frequency(VAF) of Mutant Gene;Minimal Residual Disease;

Countries

China

Contacts

Public ContactMa Jun

Institute of Hematology and Oncology of Harbin First Hospital

majun0322@126.com+86 0451-84883471

Outcome results

None listed

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