Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of AML Patients

Study Overview
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Brief Summary
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Most of patients with acute myeloid leukemia (AML) are elder and have poor prognosis despite induction chemotherapy.The regimen of cytarabine(Ara-C), aclarubicin and G-CSF (CAG regimen ) has been widely used in China for the treatment of acute myeloid leukemia (AML). Strategies to reduce the toxicity associated with intensive chemotherapy include the attenuated doses of standard regimens and myeloid growth factors. Granulocyte colony-stimulating factor(G-CSF) is efective in the prophylaxis and management of chemotherapy-induced neutropenia，but requires daily administration because of its short half-life． Pegylated granulocyte colony-stimulating factor (PEG-G-CSF )is a long-acting reagent that permits less frequent injection．The project is undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China.In order to report the efficacy and safety of PEG-G-CSF combined with Ara-C and aclarubicin for the treatment of Acute Myeloid Leukemia, compared to the regimen of Ara-C, aclarubicin and G-CSF (CAG ).

Detailed Description
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The Investigators are undertaking a parallel, multicentre, randomised open-label trial of newly diagnosed AML (not APL) patients in China. Participants are randomised selected to receive the regimen of Ara-C, aclarubicin and PEG-G-CSF , or the regimen of Ara-C, aclarubicin and G-CSF (CAG ).Platelet count, bleeding and other symptoms are evaluated before and after treatment. Adverse events are also recorded throughout the study.

Official Title
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A Multi-center Randomized Open-label Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of Acute Myeloid Leukemia Patients

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: AraC
* Drug: Aclarubicin
* Drug: Peg-G-CSF
* Drug: G-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 60 years and older, with an upper age limit of 75 years; diagnosis of AML other than APL Adequate hepatic and renal function (aspartate aminotransferase [AST], alanine aminotransferase [ALT], bilirubin and creatinine < 2.5 x upper normal limit). Exclusion Criteria: History of severe congestive heart failure or other cardiac disease that contraindicates the use of anthracyclines, including idarubicin Use of recreational drugs or history of drug addiction, within the prior 6 months Known history of positive hepatitis B surface antigens or hepatitis C virus (HCV) antibodies Patients with documented cases of human immunodeficiency virus (HIV)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental<br>Ara-C, Aclarubicin Combined PEG-G-CSF ARA-C subcutaneously in a 12-hour infusion on days 1 through 14, Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8, PEG-G-CSF 6mg subcutaneously on days 0. One course includes 28 days. | Drug: AraC<br>* ARA-C subcutaneously in a 12-hour infusion on days 1 through 14<br>* Other names: cytarabine;Drug: Aclarubicin<br>* Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8<br>* Other names: Aclarubicin A;Drug: Peg-G-CSF<br>* PEG-G-CSF 6mg subcutaneously on days 0.<br>|
| Active Comparator: Active comparator<br>Ara-C, Aclarubicin Combined G-CSF ARA-C subcutaneously in a 12-hour infusion on days 1 through 14, Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8, G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14. G-CSF was postponed or interrupted in case of white blood cell (WBC) count greater than 20 × 109/L . One course includes 28 days. | Drug: AraC<br>* ARA-C subcutaneously in a 12-hour infusion on days 1 through 14<br>* Other names: cytarabine;Drug: Aclarubicin<br>* Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8<br>* Other names: Aclarubicin A;Drug: G-CSF<br>* G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission (CR) | Bone marrow blasts not more than 5%, absence of blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count more than 1*10^9/L, platelet count more than 100*10^9/L,independence of red cell transfusions | 60 days from the enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia, PEG-G-CSF