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Cytarabine subcutaneous versus continuous infusion in the treatment of newly diagnosed acute myeloid leukemia patients

Cytarabine subcutaneous versus continuous infusion in the treatment of newly diagnosed acute myeloid leukemia patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPC-15006301
Enrollment
Unknown
Registered
2015-03-17
Start date
2015-05-01
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

Group A:idarubicin (10mg/ m2/d)
d1-3
Ara-C 100mg/ m2/d, subcutaneously, every 12 h on days 1-7
Group B:idarubicin (10mg/ m2/d)
Ara-C 100mg/ m2/d, by continuous intravenous infusion on days 1-7

Sponsors

The First Affiliated Hospital, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Obtain signed informed consent from patients or their families; 2. WHO classification of patients diagnosed with AML (except M3), including the transition from MDS AML; 3. Age 15-60 years old; 4. ECOG score of 0-2; 5. Liver and kidney function: serum bilirubin 50%.

Exclusion criteria

Exclusion criteria: 1. Acute promyelocytic leukemia; 2. There is a history of other malignancies in the past five years; 3. Serum bilirubin >2mg/dL (35 umol/L); ALT or AST >2 times the upper limit of normal; alkaline phosphatase >3 times the upper limit of normal; serum creatinine >177 umol/L; 4. HIV-positive; 5. ECOG >2 points; 6. Other serious illness may limit patients enrolled in this trial (eg advanced infection, uncontrollable diabetes, severe heart failure or angina); 7. General condition is not suitable for chemotherapy; 8. Pregnant or lactating women; 9. Can not understand or comply with the study protocol; 10. Below 15 years of age or over 60 years old patient; 11. Secondary to treatment-related AML MPN.

Design outcomes

Primary

MeasureTime frame
complete remission;

Secondary

MeasureTime frame
3-years Event-free survival;3-year Overall survival;side effects;

Countries

China

Contacts

Public ContactJin Jie
jiej0503@163.com+86 057187236702

Outcome results

None listed

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