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A multicenter study of decitabine combined with low intensive dose chemotherapy in refractory/relapse AML of children (Dec+LDC for RR –AML 18)

A multicenter study of decitabine combined with low intensive dose chemotherapy in refractory/relapse AML of children (Dec+LDC for RR –AML 18)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015872
Enrollment
Unknown
Registered
2018-04-25
Start date
2018-06-01
Completion date
Unknown
Last updated
2018-04-30

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

Conditions

Refractory/relapse AML of children

Interventions

Reinduction I:Dec+IDAG
Reinduction II:Dec+HAG

Sponsors

Children's Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. All patients meet with the criteria of refractory/ relapse of AML; 2. Newly diagnosed of AML with -5, -7, 5q-, 7q-; 3. Patients or / and guardians who have signed the Informed Consent Form; 4. Patients predicted life would be more than 3 months.

Exclusion criteria

Exclusion criteria: 1. Use of concomitant chemotherapy, radiation therapy, or immunotherapy other than receiving systemic treatment followed this protocol; 2. Patients with WBC more than 50×10^9/L after treated with decitabine and cytarabin for 5 days; 3. Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.Under such circumstances, all the research institutes are required to report directly to the person in charge of the project and decide whether to the exclude the case; 4. ECOG score 4.

Design outcomes

Primary

MeasureTime frame
remission state of bone marrow;remission state of hematology;disappear of extramedullary invasion;event-free survival;overall survival;cumulative disease rate of relapse;

Secondary

MeasureTime frame
early mortality rate;

Countries

China

Contacts

Public ContactHu Shaoyan

Children's Hospital of Soochow University

hushaoyan@suda.edu.cn+86 0512 80692929

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026