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Clinical Observation of Adjusting Treatment Scheme Based on MRD of Acute Myeloid Leukemia

Clinical Observation of Adjusting Treatment Scheme Based on MRD of Acute Myeloid Leukemia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000033235
Enrollment
Unknown
Registered
2020-05-25
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

Acute myeloid leukemia

Interventions

Group 1:Consolidation therapy after remission adopts CLAG regimen
Group 2:Consolidation therapy after remission adopts high-dose cytarabine regimen

Sponsors

First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 60 years old; 2) AML patients who have been clearly diagnosed to meet the AML Chinese Guidelines 2017 edition standards; 3) Receive treatment in our hospital; 4) ECOG PS score: 0 2 points; 5) Normal function of main organs: serum bilirubin <=1.5 ULN, serum ALT and AST<=2.5 ULN, serum Cr<=1.5 ULN.

Exclusion criteria

Exclusion criteria: 1) The bone marrow cannot be sucked by puncture; 2) Relapsed AML; 3) Received treatment with Cladribine at any time; 4) Diagnosed with other malignant tumors within the previous 12 months; 5) Women who are pregnant or breastfeeding; 6) Uncontrollable systemic fungal, bacterial or viral infections (defined as the symptoms / signs associated with the infection at the time, but no improvement despite antibiotics or other treatments) 7) Known or suspected allergy to Cladribine; 8) Known active viral infection of human immunodeficiency virus (HIV) or viral hepatitis B or C; 9) Have a clear history of neurological or mental disorders, including epilepsy or dementia; 10) According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study; 11) At the same time using other test drugs or participating in clinical trials of other drugs one month before the test.

Design outcomes

Primary

MeasureTime frame
MRD to negative rate;

Secondary

MeasureTime frame
2-year progression-free survival rate;2-year overall survival rate;

Countries

China

Contacts

Public ContactYanfang Liu

First Affiliated Hospital of Zhengzhou University

fccliuyf1@zzu.edu.cn+86 13673665109

Outcome results

None listed

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