This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML.
This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML. Patients in dose escalation stage received oral MAX-40279 at three doses, in combination with VEN and AZA in 28-day cycles. Three to six patients were enrolled at each dose level. The dose limiting toxicities (DLTs) observation period was 28 days after the first dose. All evaluable patients with ≥1 cycle treatment were included in preliminary efficacy analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Dose escalation:MAX-40279: 40 mg, 50 mg, and 60 mg twice daily (BID). Dose expantion: MAX-40279 RP2D. Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter. Azacitidine: 75 mg/m2 days 1-7. 28 days are one cycle.
Given by IV, 75 mg/m2
100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter.
Institute of Institute of Hematology & Blood Diseases Hospital ( Chinese Academy of Medical Sciences)
Tianjin, China
RECRUITINGDLT
The dose limiting toxicities, Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Dose escalation; an average of 6 months.
Adverse events (AEs), serious adverse events (SAEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 24 months.
Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D)
Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Dose escalation; an average of 6 months.
CRc
complete remission rate
Time frame: Through study completion; an average of 24 months.
RFS
Recurrence-Free Survival
Time frame: Through study completion; an average of 8 months.
DoR
duration of response
Time frame: Through study completion; an average of 8 months.
OS
overall survival
Time frame: Through study completion; an average of 24 months.
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