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The Clinical Trial of Demethylation in Preventing and Intervening the Relapse of High-Risk Pediatric Acute Myeloid Leukemia after Allo-HSCT

The Clinical Trial of Demethylation in Preventing and Intervening the Relapse of High-Risk Pediatric Acute Myeloid Leukemia after Allo-HSCT

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066776
Enrollment
Unknown
Registered
2022-12-16
Start date
2022-12-20
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

Interventions

HMAs Group:Demethylated drug

Sponsors

Children's Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. 0-18 years old. 2. Children with high-risk or relapsed AML after transplantation. 3. Obtain the consent of the child or/and the Guardian and sign the informed consent form. 4. Expected survival time greater than 3 months.

Exclusion criteria

Exclusion criteria: 1. Failure of Hematopoietic stem cell transplantation. 2. Hematopoietic or extramedullary relapse after Hematopoietic Stem Cell Transplantation. 3. Do not receive systematic demethylated drug therapy as part of the treatment regimen. 4. Patients can not be rid of transfusion dependence, have uncontrolled infection or grade III/IV acute GVHD (GVHD according to WHO criteria) . 5. Severe Heart, lung, kidney, and liver dysfunction, poor nutritional status, and inability to tolerate demethylation therapy; 6. Patients with severe infection who can not tolerate demethylating agents; 7. Any significant abnormality of co-existing diseases or mental disorders affects the patient's life safety and compliance, informed consent, study participation, follow-up or interpretation of results. In this case, all participants are required to report directly to the project manager and jointly decide whether the exclusion criteria are met. 8. The researchers evaluated other reasons for not being selected.

Design outcomes

Primary

MeasureTime frame
DFS;CR;ORR;

Countries

China

Contacts

Public ContactHu Shaoyan

Children's Hospital of Soochow University

hushaoyan@suda.edu.cn+86 512 80692929

Outcome results

None listed

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