Skip to content

A prospective, multi-center, non-intervention, observational clinical study of idarubicin hydrochloride for injection combined with cytarabine low-dose chemotherapy regimen as consolidation therapy for elderly patients with acute myelogenous leukemia (AML)

A prospective, multi-center, non-intervention, observational clinical study of idarubicin hydrochloride for injection combined with cytarabine low-dose chemotherapy regimen as consolidation therapy for elderly patients with acute myelogenous leukemia (AML)

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046789
Enrollment
Unknown
Registered
2021-05-28
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

Acute myelogenous leukemia

Interventions

Idabicin combined with cytarabine low dose chemotherapy regimen group:Nil

Sponsors

Department of Hematology, Shanxi Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Male or female, aged 60 to 85 years; 2.According to the Us National Comprehensive Cancer Network (NCCN) acute myeloid leukemia clinical; Practice Guideline (2020.v3) criteria for patients with newly histopathologically confirmed AML(except M3) and with CR after 1-2 courses of induction therapy (including mdS-transformed AML patients); 3.Comply with AML diagnosis, including any of the following conditions: (1)Patients with CGA score of unfit; (2)Patients with CGA score of fit and PS score of 1-3; (3)Other patients with CGA score of fit who wish to receive low-dose chemotherapy; 4.Can tolerate chemotherapy regimens; 5.Understand and voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with malignant tumors of other organs; 2.Abnormal liver and kidney function, total bilirubin level, serum creatinine level more than 2 times of the upper limit of normal value (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 3 times of ULN (except AML); 3.Patients previously with severe heart disease, including myocardial infarction, grade 3-4 heart insufficiency, congestive heart failure requiring treatment, or left ventricular systolic ejection fraction below the normal range; 4.Patients with uncontrolled infection, or are currently receiving intravenous antibiotic therapy, except preventive antibiotics, antiviral and antifungal infection treatments; 5.Patients can not be enrolled which will be judged by the researchers.

Design outcomes

Primary

MeasureTime frame
2 years disease free survival ;

Secondary

MeasureTime frame
2 year overall survival;The incidence of grade 3-4 hematologic and non-hematologic adverse drug reactions;

Countries

China

Contacts

Public ContactSu Liping

Shanxi Provincial Cancer Hospital

sulp2005@sohu.com+86 13835158122

Outcome results

None listed

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