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 .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Drug :SKLB1028 ;Drug: Cytarabine ;Drug: Daunorubicin
West China Hospital of Sichuan University
Chengdu, China
RECRUITINGNumber of participants with dose limiting toxicities (DLTs)
A DLT is defined as any Grade ≥ 3 non-hematologic or extramedullary toxicity that occur during the DLT assessment period, and that is considered to be possibly, probably, or definitely related to onsolidation therapies including the study drugs.
Time frame: up to Day42
Pharmacokinetics profile of SKLB1028
Observed trough concentration (Ctrough)
Time frame: Days 8, 15, 18, and 21 for remission induction and Days 8, and 21 for consolidation and Days 1 for maintenance
CR rate after the induction therapy
CR is defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm\^3 and platelet count of ≥ 100,000/mm\^3, bone marrow blasts \< 5%. There must be no evidence of Auer rods and no evidence of extramedullary leukemia.
Time frame: up to 3months
Duration of remission
Duration of remission included duration of composite complete remission (CRc), duration of complete remission (CR)/ complete remission with partial hematologic recovery (CRh), duration of CRh, duration of CR and duration of response (CRc + partial remission (PR).
Time frame: up to 24months
Overall Survival
OS was measured from the date of the first dose of treatment to the date of death from any cause or to the last date that the patient was known to be alive
Time frame: up to 60months
Event-Free Survival
EFS was defined as the time from randomization until treatment failure (Composite complete remission (CRc) or partial remission (PR) were not reached within 4 cycles), relapse (excluding relapse after PR), or death from any cause, whichever occurs first.
Time frame: up to 24months
Leukemia-free survival
The LFS was defined as the time from the date of first CR until the date of documented relapse (excluding relapse from PR) or death for participants who achieved CR (relapse date or death date - first CR disease assessment date + 1).
Time frame: up to 24months
Rate of hematopoietic stem cell transplantation
Transplantation rate is defined as the percentage of participants undergoing hematopoietic stem cell transplant (HSCT).
Time frame: up to 12months
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