Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of AML Patients
Study Details
Study Description
Brief Summary
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 ).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Experimental 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
ARA-C subcutaneously in a 12-hour infusion on days 1 through 14
Other Names:
Drug: Aclarubicin
Aclarubicin(Acla) 5~7mg/m2/d,intravenously on days 1 through 8
Other Names:
Drug: Peg-G-CSF
PEG-G-CSF 6mg subcutaneously on days 0.
|
Active Comparator: Active comparator 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
ARA-C subcutaneously in a 12-hour infusion on days 1 through 14
Other Names:
Drug: Aclarubicin
Aclarubicin(Acla) 5~7mg/m2/d,intravenously on days 1 through 8
Other Names:
Drug: G-CSF
G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14.
|
Outcome Measures
Primary Outcome Measures
- Complete remission (CR) [60 days from the enrollment]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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age 60 years and older, with an upper age limit of 75 years;
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diagnosis of AML other than APL
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Adequate hepatic and renal function (aspartate aminotransferase [AST], alanine aminotransferase [ALT], bilirubin and creatinine < 2.5 x upper normal limit).
Exclusion Criteria:
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History of severe congestive heart failure or other cardiac disease that contraindicates the use of anthracyclines, including idarubicin
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Use of recreational drugs or history of drug addiction, within the prior 6 months
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Known history of positive hepatitis B surface antigens or hepatitis C virus (HCV) antibodies
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Patients with documented cases of human immunodeficiency virus (HIV)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Qilu hospital, Shandong University | Jinan | Shandong | China | 250012 |
Sponsors and Collaborators
- Shandong University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AML- PEG-G-CSF