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OncoMatch/Clinical Trials/NCT05657639

CAV Regimen for R/R AML

Is NCT05657639 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including CAV Regimen and MEC Regimen for acute myeloid leukemia.

Phase 2RecruitingThe First Affiliated Hospital of Soochow UniversityNCT05657639Data as of May 2026

Treatment: CAV Regimen · MEC RegimenThis study aims to investigate the efficacy and safety of cladribine, combined with low-dose cytarabine and venetoclax (CAV regimen) for relapsed/refractory acute myeloid leukemia (R/R AML).

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: standard or intensive induction therapy

failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy

Cannot have received: allogeneic hematopoietic stem cell transplantation

Exception: patients who relapsed after allogeneic hematopoietic stem cell transplantation

Patients who relapsed after allogeneic hematopoietic stem cell transplantation

Cannot have received: organ transplant

Patients who have received organ transplants

Lab requirements

Kidney function

Ccr ≥ 50 ml/h

Liver function

total bilirubin ≤ 1.5x ULN, ALT/AST ≤ 2.5x ULN (or ≤ 1.5x ULN with liver involvement)

Cardiac function

No history of clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular tachycardia, atrial fibrillation, II-degree heart block, myocardial infarction within one year, congestive heart failure, or symptomatic coronary heart disease requiring drug treatment

Liver function abnormalities (total bilirubin > 1.5 times of the upper limit of the normal range, ALT/AST > 2.5 times of the upper limit of the normal range or patients with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or renal dysfunction (Ccr<50ml/h). Patients with a history of clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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