drugset / Trial / NCT02072811
Role of the Therapy Tailored to Risk Factors in Treating Adult Patients (≤60) With Acute Myeloid Leukemia
Phase 3
Unknown
400 enrolled
dr hab. n. med. Agnieszka Wierzbowska
Copernicus Memorial Hospital · collabPolish Adult Leukemia Group · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
In view of the diversity of the biology of acute myeloid leukemia (AML) therapy in individual patients must be individualized. One of the tools for this is molecular-cytogenetic stratification. It divides patients into five categories (prognostic groups): Favorable, Intermediate-1, Intermediate-2, Adverse and Very adverse risk. After remission proceedings are tailored depending on prognostic determined groups. Research of PALG group in the application in the second line regimen CLAG and CLAG-M proved high effectiveness of this treatment with low toxicity. Considering experience of PALG groups, it seems that the use of the schema CLAG early as the second induction therapy is a viable treatment option.
Timeline
- Start
- 2014-02
- Primary completion
- 2018-02
- Completion
- 2018-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cladribine | Small molecule | 5 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 3 g | Intravenous |
| Subject | Daunorubicin | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 10 mg/m2 | Intravenous |
| Background | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 30 unknown | Subcutaneous |