SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Newly Diagnosed Acute Myeloid Leukemia (AML) Clinical Trial

Official title:
A Single-Arm, Multicenter, Open-Label, Dose- Escalating and Expanding,Phase I/II Study of SKLB1028 Combined With "7+3" Standard Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Status Recruiting

Clinical Trial Summary

The purpose of this study is to describe the dose limiting toxicities (DLT) of SKLB1028 when combined with cytarabine/ daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of SKLB1028 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of SKLB1028 when given in combination with cytarabine/daunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia .

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Newly Diagnosed Acute Myeloid Leukemia (AML)

Clinical Trial Details

NCT number	NCT05445154
Study type	Interventional
Source	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact	Liu Ting, Chief doctor
Phone	+8618980601240
Email	liuting@scu.edu.cn
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	August 31, 2021
Completion date	December 31, 2026

View Details

See also
	Status	Clinical Trial	Phase
	Active, not recruiting	`NCT03173248` - Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation	Phase 3
	Active, not recruiting	`NCT02632708` - Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation	Phase 1