Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 ).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Active Comparator | 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AraC | Drug | ARA-C subcutaneously in a 12-hour infusion on days 1 through 14 |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Hou, Docter | Contact | houming@medmail.com.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hospital, Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D015250 | Aclarubicin |
| C486981 | pegylated granulocyte colony-stimulating factor, human |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aclarubicin | Drug | Aclarubicin(Acla) 5~7mg/m2/d,intravenously on days 1 through 8 |
|
|
| Peg-G-CSF | Drug | PEG-G-CSF 6mg subcutaneously on days 0. |
|
| G-CSF | Drug | G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14. |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |