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The clinical study of initial induced remission failure in elderly patients with acute myeloid leukemia treated by IA in combination with decitabine

The clinical study of initial induced remission failure in elderly patients with acute myeloid leukemia treated by IA in combination with decitabine

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-16008952
Enrollment
Unknown
Registered
2016-08-02
Start date
2016-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Acute myeloid leukemia

Interventions

Study Group:Decitabine+IA

Sponsors

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

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. ALL candidates for this trial should first be participants in the "Study of optimizing induction chemotherapy for elderly patients with acute myeloid leukemia based on peripheral blasts clearance rate" trial; 2. Patients who resulted in Non-remission after the first induction can be included in this trial; 3. All patients will be evaluated by the researchers to see if they are qualified for this trial.

Exclusion criteria

Exclusion criteria: 1. Patients with ejection fraction <50% (by echocardiography or multigated acquisition scan), Heart failure (NYHA III/IV); 2. Chronic pulmonary disease causing severe anoxia; 3. Liver and renal insufficiency not caused by AML (AST, ALT, serum bilirubin, creatinine higher than 2* upper normal serum level); 4. Patients with brain function damage or other mental disease; 5. Patients undergo major operation within three weeks; 6. Patient meets the conditions of "not suitable" and "unfit for chemotherapy" in the Pre-treatment risk assessment stratification scale for elderly AML (non-M3).

Design outcomes

Primary

MeasureTime frame
Complete Remission Rate;Partial Remission Rate;

Secondary

MeasureTime frame
Overall Survival;Progression Free Survival;Relapse Free Survival;

Countries

China

Contacts

Public ContactJunmin Li

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