Unrelated Umbilical Cord Blood Microtransplantation Combined with Demethylation Drug in Maintenance Therapy of Acute Myeloid Leukemia (AML)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300067744

Enrollment

Unknown

Registered

2023-01-20

Start date

2023-01-28

Completion date

Unknown

Last updated

2023-05-15

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

Test group:Umbilical Cord Blood + cytarabine

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with AML confirmed by bone marrow morphology and immunology; 2. Patients with bone marrow cytological remission after induction therapy; 3. Young AML patients with a high risk of relapse met the following criteria: < 60 years old, low-risk AML patients with intermediate and high-risk AML without hematopoietic stem cell transplantation intention or positive minimal residual lesion (MRD); 4. Aged 18-80 years; 5. Liver and renal function: blood bilirubin <= 35µmol/L, AST/ALT below 2 times the upper limit of normal, blood muscle liver <= 150µmol/L; 6. Normal cardiac function; 7. Physical condition score 0-2; 8. Obtain informed consent signed by themselves or my guardians.

Exclusion criteria

Exclusion criteria: 1. APL patients, therapy-related AML; 2. Allergic to any of the drugs involved in the protocol; 3. Obvious contraindications to chemotherapy drugs; 4. Severe heart disease, including myocardial infarction and cardiac insufficiency; 5. Concurrent with other malignant tumors; 6. HIV-positive patients; 7. Concurrent with other hematological diseases; 8. Pregnant or lactating women; 9. Failure to understand or comply with the study protocol; 10. Previous history of intolerance or allergy to similar drugs; 11. Participating in other clinical investigators; 12. Any other circumstance impeding the study; 13. Cases considered inappropriate by the investigator.

Design outcomes

Primary

Measure	Time frame
Minimal residual disease negative rate;Progression-free survival;	—

Secondary

Measure	Time frame
Bone marrow morphology, gene, immune typing and cytogenetic evaluation;two-years overall survival;Relapse-free survival;	—

Countries

China

Contacts

Public ContactShen Jingzhi

The First Affiliated Hospital of Dalian Medical University

sjz060902@sina.com+86 180 9887 5673

Outcome results

None listed

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