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Decitabine plus modified CAG versus idarubicin plus cytarabine as induction treatment in medically fit elderly acute myeloid leukemia: a multicenter, randomized, phase III trial

Decitabine plus modified CAG versus idarubicin plus cytarabine as induction treatment in medically fit elderly acute myeloid leukemia: a multicenter, randomized, phase III trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035270
Enrollment
Unknown
Registered
2020-08-06
Start date
2015-03-01
Completion date
Unknown
Last updated
2021-06-14

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

Conditions

elderly acute myeloid leukemia

Interventions

D-CAG group:D-CAG
3+7group:3+7

Sponsors

Department of Hematology, Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 60 to 75 years; 2. In medically fit(Eastern Cooperative Oncology Group (ECOG) performance status and Charlson comorbidity index (CCI) of 0-2).

Exclusion criteria

Exclusion criteria: 1) Acute promyelocytic leukemia; 2) Uncontrolled infections including active tuberculosis; 3) liver dysfunction (total bilirubin >= 2 times the upper limit of normal [ULN] or alanine amino transferase or aspartate aminotransferase >= 2 ULN); 4) renal dysfunction(creatinine >= 2 ULN or creatinine clearance < 30mL/min); 5) severe concomitant conditions not suitable for the trial, such as cardiovascular disease or psychiatric disorders.

Design outcomes

Primary

MeasureTime frame
One-year overall survival;

Secondary

MeasureTime frame
Complete response rate;Event-free survival;Treatment-related mortality;Cumulative incidence of relapse;

Countries

China

Contacts

Public ContactQifa Liu

Department of Hematology, Nanfang Hospital, Southern Medical University

liuqifa628@163.com+86 13602791429

Outcome results

None listed

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