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OncoMatch/Clinical Trials/NCT06651866

Dose-escalation Study of D-CMG Regimen for the Treatment of Elderly Newly Diagnosed AML Patients

Is NCT06651866 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies D-CMG for acute myeloid leukemia.

Phase 1RecruitingThe First Affiliated Hospital of Xiamen UniversityNCT06651866Data as of May 2026

Treatment: D-CMGto observe the dose-limiting toxicity (DLT) of liposomal mitoxantrone hydrochloride injection combined with cytarabine and decitabine in the initial treatment of acute myeloid leukemia (AML), to explore the maximum tolerated dose (MTD) of the combined D-CMG regimen, and to evaluate its safety and efficacy

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Excluded: BCR ABL1 translocation

AML with BCR-ABL1 translocation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Kidney function

Estimated creatinine clearance rate ≥ 30 mL/min

Liver function

AST and ALT ≤ 3.0 x ULN (unless considered due to leukemic organ involvement). Bilirubin ≤ 1.5 x ULN (unless considered due to leukemic organ involvement).

Cardiac function

Clinically significant QTc prolongation (men > 450 ms; women > 470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block, history of myocardial infarction within the past year, congestive heart failure, and coronary artery disease requiring medication [excluded]

AST and ALT ≤ 3.0 x ULN (unless considered due to leukemic organ involvement). Bilirubin ≤ 1.5 x ULN (unless considered due to leukemic organ involvement). Estimated creatinine clearance rate ≥ 30 mL/min. Clinically significant QTc prolongation (men > 450 ms; women > 470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block, history of myocardial infarction within the past year, congestive heart failure, and coronary artery disease requiring medication [excluded]

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

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