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cladribine 5 mg/m2, d1-5; G-CSF 300 µg, d0-9; aclarubicin 10 mg, d3-6; cytarabine 10mg/ m2 q12h, SC, d3-9; 4 weeks per cycle.

Cladribine 5 mg/m2, intravenous drip,d1-5,4 weeks per cycle.

Cladribine Injection

aclarubicin 10 mg, intravenous drip,d3-6,4 weeks per cycle.

G-CSF 300 µg,subcutaneous injection, d0-9,4 weeks per cycle.

G-CSF

cytarabine 10mg/ m2, subcutaneous injectionq,q12h, d3-9,4 weeks per cycle.

cytarabine

wang hua, MD.

hua wang, MD.

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.

The low-intensity chemotherapy were developed to reduce the early mortality and improve the benefit-risk ratio for longterm survival in elderly or unfit AML patients.Previous studies revealed that the standard dose of CAG regimen consisting of low-dose cytarabine and aclarubicin in combination with granulocyte colonystimulating factor (G-CSF) priming as an induction therapy was well-tolerated by patients and led to a complete remission (CR) rate of 50.0% in patients aged≥ 70 years. Cladribine (2-chlorodeoxyadenosine ) is a nucleoside analogue of anti-adenosine deaminase that has extensive antitumor activity in hematological tumor.The purine analog 2-CdA increases the uptake of Ara-C and the accumulation of its active cytotoxic metabolite 5α-triphosphate Ara-C (Ara-CTP) in leukemia cells. This finding suggests that synergy occurs between cladribine and cytarabine. 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 unfit patients with AML.Patients will receive C-CAG regimen as follows: cladribine 5 mg/m2, d1-5; G-CSF 300 µg, d0-9; aclarubicin 10 mg, d3-6; cytarabine 10mg/ m2 q12h, SC, d3-9; 4 weeks per cycle. The participants are permitted to quit the study if complete remission (CR) was not achieved after two courses of chemotherapy.The participants will be treated for a total of six cycles unless disease progression or unacceptable side effects are observed or participants withdrew their consent.

Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML

Efficacy and Safety of Cladribine in Combination With G-CSF,Low-dose Cytarabine and Aclarubicin in Newly Diagnosed Unfit Patients With Acute Myeloid Leukemia

Safety and tolerability of Cladribine in Combination With treatment for CAG for AML (type, frequency, severity and relationship of adverse events to study treatment).

The time from registration to induction failure, death or relapse whichever occurs first

The time from the date of registration to the date of death, whatever the cause. Patients still alive at the date last contact will be censored.

Assessment of the prognostic value of Minimal Residual Disease (MRD) by flowcytometry or PCR

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML	NCT04254640	Acute Myeloid L... Elderly Patient... Newly Diagnosed	Cladribine Inje... Aclarubicin G-CSF cytarabine	18 Years - 90 Years	Sun Yat-sen University
Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML	NCT04254640	Acute Myeloid L... Elderly Patient... Newly Diagnosed	Cladribine Inje... Aclarubicin G-CSF cytarabine	18 Years - 90 Years	Sun Yat-sen University

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