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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06532058 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CDK9 inhibitor, allogeneic hematopoietic stem cell transplantation, CAR-T cell therapy disqualifies patients from enrollment.
Are patients with ABL1 alterations eligible?
No. ABL1 fusion is an exclusion criterion.
Are patients with BCR alterations eligible?
No. BCR fusion is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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