Phase II Study of Sonrotoclax Combined With Chemotherapy in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Phase 2 Active not recruiting 47 enrolled Shanghai Jiao Tong University School of Medicine BeiGene · collab Ruijin Hospital · collab

NaSingle-groupOpen-labelTreatment

Summary

This single-armed study aims to investigate the safety and efficacy of sonrotoclax in combination with intensive chemotherapy in subjects with newly diagnosed AML. Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet (ELN) recommendations and MRD status to receive specific consolidation therapy after the induction therapy.

Timeline

Start: 2024-10-30
Primary completion: 2027-10-31
Completion: 2028-06-30

Publications

Zhang Y, Wu M, Jin Z, Yang L, Huang X, Li W, Zhu H, Wang W, Chen Q, Liu L, Chen Z, Wang S, Li J. Risk-stratified treatment of sonrotoclax with chemotherapy in newly diagnosed acute myeloid leukemia: a study protocol. Future Oncol. 2025 Apr;21(8):953-958. doi: 10.1080/14796694.2025.2469487. Epub 2025 Feb 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sonrotoclax	Other / unclassified	160 mg	Oral
Background	Azacitidine	Other / unclassified	75 mg/m2	Subcutaneous
Background	Cytarabine	Small molecule	100 mg/m2	Intravenous
Background	Cytarabine	Small molecule	1 g	Intravenous
Background	Cytarabine	Small molecule	2 g	Intravenous
Background	Daunorubicin	Small molecule	40 mg/m2	Intravenous
Background	Daunorubicin	Small molecule	60 mg/m2	Intravenous
Background	Idarubicin	Small molecule	6 mg/m2	Intravenous
Background	Idarubicin	Small molecule	10 mg/m2	Intravenous

Phase II Study of Sonrotoclax Combined With Chemotherapy in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Summary

Timeline

Publications

Drugs

Indications