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Clinical investigation plan on the effects and safety of sequential and immune maintenance therapy with the liposome of doxorubicin hydrochloride and low-dose cytarabine + G-CSF on elderly acute myeloid leukemia

Clinical investigation plan on the effects and safety of sequential and immune maintenance therapy with the liposome of doxorubicin hydrochloride and low-dose cytarabine + G-CSF on elderly acute myeloid leukemia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045069
Enrollment
Unknown
Registered
2021-04-04
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-11-08

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

experimental group:Liposomal doxorubicin+ ara-C+ G-CSF

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients over 60 years who are assessed as ineligible for chemotherapy and there are no limit of gender; 2.Patients who were diagnosed with acute myeloid leukemia (excluding APL) including secondary AML and treatment-realted AML; 3.ECOG score >= 1; 4.The patients themselves or their family members are willing to participate in the study and sign an informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with severe cardiopulmonary or other important organ dysfunction; 2.Patients who cannot comprehend or follow the plan with a brain disorder or serious mental diseases; 3.Patients combined with other malignant tumors; 4.Patients whose necessary treatment plan and follow-up observation cannot be guaranteed.

Design outcomes

Primary

MeasureTime frame
Objective response rate;overall survival;

Secondary

MeasureTime frame
Progress free survival;relapse rate;

Countries

China

Contacts

Public ContactZhou Kang

The Second Affiliated Hospital of Chongqing Medical University

18602348552@163.com+86 13996301136

Outcome results

None listed

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