drugset / Trial / NCT05313958
Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children
Phase 2/3
Unknown
43 enrolled
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First Affiliated Hospital of Shantou University Medical College · collabGuangzhou First People's Hospital · collabJiangxi Province Children's Hospital · collabMaternal and Child Health Hospital of Foshan · collabSecond Xiangya Hospital of Central South University · collabSouthern Medical University, China · collabThe First Affiliated Hospital of Guangzhou Medical University · collabThe First Affiliated Hospital of Nanchang University · collabThird Affiliated Hospital, Sun Yat-Sen University · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter, single arm, prospective, intervention trial. Since cladribine can enhance the biological activity and self-protection of cytarabine, giving cladribine and cytarabine together may kill more cancer cells. 10 centers from South China Childhood Leukaemia Collaborative Group carry out the SCCLG-M5-2022 regimen including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period for the treatment of newly dignosed acute monocytic leukemia (M5). The targeted drugs sorafenib is used for FLT3 positive acute monocytic leukemia to inhibit the serine / threonine kinase activity of FLT3.
Timeline
- Start
- 2021-12-01
- Primary completion
- 2026-03-30
- Completion
- 2026-03-30
Publications
- Background Liu LP, Zhang AL, Ruan M, Chang LX, Liu F, Chen X, Qi BQ, Zhang L, Zou Y, Chen YM, Chen XJ, Yang WY, Guo Y, Zhu XF. Prognostic stratification of molecularly and clinically distinct subgroup in children with acute monocytic leukemia. Cancer Med. 2020 Jun;9(11):3647-3655. doi: 10.1002/cam4.3023. Epub 2020 Mar 26.
- Results Weis TM, Marini BL, Bixby DL, Perissinotti AJ. Clinical considerations for the use of FLT3 inhibitors in acute myeloid leukemia. Crit Rev Oncol Hematol. 2019 Sep;141:125-138. doi: 10.1016/j.critrevonc.2019.06.011. Epub 2019 Jun 28.
- Results Rubnitz JE, Crews KR, Pounds S, Yang S, Campana D, Gandhi VV, Raimondi SC, Downing JR, Razzouk BI, Pui CH, Ribeiro RC. Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial. Leukemia. 2009 Aug;23(8):1410-6. doi: 10.1038/leu.2009.30. Epub 2009 Feb 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cladribine | Small molecule | 5 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 2 g | — |
| Subject | Sorafenib | Small molecule | 200 mg/m2 | Oral |
| Background | G-CSF | Unknown | 5 ug/kg | — |
| Background | Idarubicin | Small molecule | 10 mg/m2 | — |
| Background | Mitoxantrone | Small molecule | 10 mg/m2 | — |