Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML
NCT04254640 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2020-12-17
Summary
In this study, the investigators conducted a phase II trial that evaluated the efficacy and safety of cladribine in combination with modified CAG regimen (low-dose cytarabine and aclarubicin) in elderly patients with AML.
Conditions
- Acute Myeloid Leukemia
- Elderly Patients
- Newly Diagnosed
Interventions
- DRUG
-
Cladribine Injection
Cladribine 5 mg/m2, intravenous drip,d1-5,4 weeks per cycle.
- DRUG
-
Aclarubicin
aclarubicin 10 mg, intravenous drip,d3-6,4 weeks per cycle.
- DRUG
-
G-CSF
G-CSF 300 µg,subcutaneous injection, d0-9,4 weeks per cycle.
- DRUG
-
cytarabine 10mg/ m2, subcutaneous injectionq,q12h, d3-9,4 weeks per cycle.
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
wang hua, MD. · sun yat-sun university cancer
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-01
- Primary Completion
- 2023-06-01
- Completion
- 2023-12-31
Countries
- China
Study Locations
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