Clinical trial · Interventional
Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of AML Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 ).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aclarubicin | Drug | — | UNRESOLVED |
| AraC | Drug | — | UNRESOLVED |
| G-CSF | Drug | — | UNRESOLVED |
| Peg-G-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Experimental
- description
- 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.
- interventionNames
- Drug: AraC
- Drug: Aclarubicin
- Drug: Peg-G-CSF
- type
- ACTIVE_COMPARATOR
- label
- Active comparator
- description
- 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.
- interventionNames
- Drug: AraC
- Drug: Aclarubicin
- Drug: G-CSF
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. age 60 years and older, with an upper age limit of 75 years; 2. diagnosis of AML other than APL 3. Adequate hepatic and renal function (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], bilirubin and creatinine \< 2.5 x upper normal limit). Exclusion Criteria: 1. History of severe congestive heart failure or other cardiac disease that contraindicates the use of anthracyclines, including idarubicin 2. Use of recreational drugs or history of drug addiction, within the prior 6 months 3. Known history of positive hepatitis B surface antigens or hepatitis C virus (HCV) antibodies 4. Patients with documented cases of human immunodeficiency virus (HIV)
References
Publications (0)
Data not yet available