Acute Myeloid Leukemia Clinical Trial
Official title:
A Multicenter,Open-label,Radonmized Study on the Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years Old
The purpose of this study is to determine whether the escalation dosage of Daunorubicin and cytarabine is effective and safety in the treatment of older adult Chinese acute myeloid leukemia(AML) patients aged 55 to 65 years.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 2021 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 55 Years to 65 Years |
Eligibility |
Inclusion Criteria: - primary AML(except APL patients); - ECOG PS:0-2 Exclusion Criteria: - AML patient who has already received induction treatment, no matter what the outcome is; - Treatment-related AML; - Active cancer patients who's condition need to be treated; - The one with serious infectious diseases(eg.uncontrolled tuberculosis or invasive pulmonary aspergillosis) - Active heart disease. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Treatment and Diagnosis Center of Leukemia | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Jianxiang Wang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall survival | 3 years | Yes | |
Secondary | complete remission rate | 2 months | No | |
Secondary | relapse free survival | 3 years | No | |
Secondary | complete remission rate in different risk group | 2 month | No | |
Secondary | treatment-related mortality | 2 months | Yes |
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