OncoMatch/Clinical Trials/NCT06532058
Phase IIa Study to Assess Safety and Efficacy in the Relapsed/Refractory Acute Myeloid Leukemia
Is NCT06532058 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies QHRD107 capsule，Venclexta and Azacitidine for relapsed/refractory acute myeloid leukemia (r/r-aml).
Treatment: QHRD107 capsule，Venclexta and Azacitidine — The purpose of this study is to assess the safety and efficacy of QHRD107 capsule combined with Venclexta and azacitidine in the treatment of relapsed/refractory acute myeloid leukemia: a single-arm, open, multicenter Phase IIa study
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: ABL1 fusion
Excluded: BCR fusion
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: CDK9 inhibitor
Subjects previously treated with other CDK9 inhibitors
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: within 60 days of their initial investigational treatment
Patients who have received allogeneic hematopoietic stem cell transplantation within 60 days of their initial investigational treatment
Cannot have received: CAR-T cell therapy
Patients who have previously received CAR-T therapy
Lab requirements
Blood counts
White blood cell (WBC) count <25×10^9 cells/L (hydroxyurea is allowed to control the white blood cell count before treatment)
Kidney function
creatinine clearance ≥50 mL/min (Cockroft-Gault formula)
Liver function
total bilirubin (TBIL) ≤1.5× ULN; ALT and AST ≤2.5×ULN
Cardiac function
No significant active cardiovascular disease within previous 6 months; NYHA ≥III heart failure; angina requiring surgery; unstable angina; MI; poorly controlled hypertension (systolic ≥160 mmHg, diastolic ≥90 mmHg); uncontrolled arrhythmias; LVEF <50%; QTc >450 ms (men), >470 ms (women), or on QT-prolonging meds
White blood cell (WBC) count <25×10^9 cells /L (hydroxyurea is allowed to control the white blood cell count before treatment); adequate liver function: total bilirubin (TBIL) ≤1.5× ULN; ALT and AST ≤2.5×ULN; adequate renal function: creatinine clearance ≥50 mL/min (Cockroft-Gault formula); significant active cardiovascular disease within the previous 6 months, including but not limited to: ≥III Heart failure as defined by the New York Heart Association (NYHA); Angina pectoris requiring surgical treatment, unstable angina pectoris, myocardial infarction; Hypertension that remains poorly controlled after treatment (i.e., systolic ≥160 mmHg, diastolic ≥90 mmHg); Uncontrolled arrhythmias; The left ventricular function resting ejection fraction measured by echocardiography was less than 50%. QT interval: > 450 ms for men and > 470 ms for women (according to the QTcF formula), or are on medication known to lengthen the QT/QTc interval, or have other factors that may lengthen the QTc interval; Or for patients whose QT interval is still > 450 ms after QT interval prolongation treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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