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Study of Chidamide combined decitabine and etoposide in treating refractory and relapsed adult AML

Study of Chidamide combined decitabine and etoposide in treating refractory and relapsed adult AML

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015332
Enrollment
Unknown
Registered
2018-03-23
Start date
2018-04-01
Completion date
Unknown
Last updated
2018-03-26

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

Conditions

Acute myeloid leukemia

Interventions

Case series:CDE regimen

Sponsors

Department of Hematology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. To be aged 18~ 75years and the elderly patient (60-75y)should be evaluated as fit; 2. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2; 3. Acute myeloid leukemia diagnosied by MICM criterion (rule out APL); 4. Expected survival longer than 3 months; 5. Meets the diagnosis criterion of refractory AML: Didn't reach CR after two cycles of standard induction; With blasts/leukemic cell clearance lower than 50% after one cycle of standard induction; Relapse within 6 months after first CR; Relapse later than 6 months after first CR and didn't respond to the former induction regimen; Relapse more than 2 times; 6. Meets the diagnosis criterion of relapse AML: more than 5% blasts found in bone marrow/peripheral blood after CR(rule out other cause, consolidation etc.); 7. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled infection or Other severe condition that patients can not tolerate chemotherapy; 2. relapsed more than 1 year after the last chemotherapy; 3. Heart failure NYHA III/IV, severe arrhythmia, ejection fraction less than 50% by echocardiography; 4. Severe neurological or psychiatric history; 5. Allergy to any drug in the CDE regimen; 6. Patients with a "currently active" second malignancy; 7. Patients underwent stem cell transplatation; 8. Patients with extra-medullary leukemia.

Design outcomes

Primary

MeasureTime frame
Complete remission rate;mortality related to study drug;

Secondary

MeasureTime frame
one year overall survival;remission duration;adverse event;

Countries

China

Contacts

Public ContactLi Junmin

Department of Hematology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

lijunmin@medmail.com.cn+86 13817712211

Outcome results

None listed

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