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A prospective, open-label, single-arm, single-arm clinical trial of HCV regimen (decitabine/azacytidine + Cladribine + Venetoclax) in the treatment of relapsed/refractory childhood AML

A prospective, open-label, single-arm, single-arm clinical trial of HCV regimen (decitabine/azacytidine + Cladribine + Venetoclax) in the treatment of relapsed/refractory childhood AML

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058734
Enrollment
Unknown
Registered
2022-04-15
Start date
2022-04-29
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

acute myeloid leukemia

Interventions

HCV:Venetoclax+azacitidine/decitabine+cladribine

Sponsors

Children's Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age< 18 years old, Male and female unlimited; 2. AML patients diagnosed according to the 2016 World Health Organization (WHO) diagnostic criteria for myeloid malignancies (except M3 with positive PML/RARA) ; 3. Patients who have had at least one previous systemic therapy (including chemotherapy, Hematopoietic stem cell, etc.) without remission or relapse after remission; 4. ECOG score was 0-3; 5. Expected Survival Time =3 months; 6. No serious heart, lung, liver, Kidney Disease; 7. The patient or his or her parents understand and are willing to sign this informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previously allergic to a drug included in a test protocol or to a drug with a similar chemical structure to the drug being tested; 2. Down syndrome associated with AML3; 3. Mental illness or other conditions, for which informed consent is not available; 4. Abnormal liver function (TBL> 3 times the upper limit of normal value, ALT/AST> 10 times the upper limit of normal value) ; 5. Abnormal renal function (Serum Creatinine> 3 times the upper limit of normal value) ; 5. The researchers determined that it was not suitable for the participants.

Design outcomes

Primary

MeasureTime frame
complete remission;complete remission with incomplete bloodcount recovery;partial remission;Minimal residual disease;

Secondary

MeasureTime frame
event-free-survival;relapse-free survival;overall survival;Volume of blood transfusion;time of Hematological recovery;Infection rate;

Countries

China

Contacts

Public ContactHu Shaoyan
hushaoyan@suda.edu.cn+86 512 80692929

Outcome results

None listed

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