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Clinical study of demethylation intervention to prevent recurrence after acute leukemia/MDS allogeneic hematopoietic stem cell transplantation

Clinical study of demethylation intervention to prevent recurrence after acute leukemia/MDS allogeneic hematopoietic stem cell transplantation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054774
Enrollment
Unknown
Registered
2021-12-26
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-12-05

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

Conditions

Acute Leukemia/Myelodysplastic syndrome

Interventions

Azacitidine treatment group:Azacitidine
Decitabine treatment group:Decitabine

Sponsors

Ningbo First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Allogeneic hematopoietic stem cell transplantation in patients with confirmed AML/high-risk MDS; 2. The age range is 14-70 years old (including 14 years old and 70 years old); 3. Expected survival period >= 3 months; 4. Good organ function level: no abnormal function of important organs such as heart, lung, liver and kidney, and can withstand high-dose chemotherapy; 5.ANC (absolute neutrophil value >= 0.5x10^9/L; PLT >= 50 x 10^9/L); 6. From the end of receiving any anti-tumor therapy (including radiotherapy, chemotherapy, surgery or molecular targeted therapy) to participation in the washout period of this trial ?4 weeks. No current GVHD and no previous history of grade 3 or above aGVHD; 7. Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent in writing.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating patients; 2. Previously known allergic or resistant to azacitidine or decitabine; 3. Investigators evaluate those who cannot tolerate super-strong conditioning regimens; 4. Other reasons for not being selected by the investigator's evaluation; 5. Severe active infection, the investigator evaluates those who cannot tolerate preconditioning.

Design outcomes

Primary

MeasureTime frame
minimal residual disease;immature cells;overall survival;relapse-free survival;

Countries

China

Contacts

Public ContactZhang Ping/Ouyang Guifang

Ningbo First Hospital

lingdujianke@163.com+86 13819811995

Outcome results

None listed

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