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

Official title

Dose Escalation Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Decitabine and Cytarabine (D-CMG) for the Treatment of Elderly Newly Diagnosed Acute Myeloid Leukemia (AML) Patients

Overview

to 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

Interventions

• Drug D-CMG
  Liposomal mitoxantrone hydrochloride injection (Doxorubicin®): Used after dilution with 250mL of 5% glucose injection (50mg/mL), with an intravenous drip time of at least 60 minutes. * Level 1: 12mg/m2, IV drip, day 4; * Level 2: 18mg/m2, IV drip, day 4; Decitabine: 25mg, IV drip, days 1-3; Cytarabine: 10mg/m2, every 12 hours, IV drip, days 4-10; G-CSF: 300 ug, IV drip, days 1-5; Each cycle is 4 weeks, with a total of 2 cycles, and DLT is observed in the first cycle. Note: Patients who achieve

Primary outcome measures

• Maximum tolerated dose (MTD) [Time frame: Up to 24 months]

Secondary outcome measures (4)

• Complete Response Rate (CR) [Time frame: Up to 24 months]
• Complete Response with incomplete blood count recovery (CRi) [Time frame: Up to 24 months]
• Disease free survival (DFS) [Time frame: Up to 24 months]
• Overall survival (OS) [Time frame: Up to 24 months]

Eligibility criteria

Inclusion criteria

• Histologically confirmed acute myeloid leukemia (non-M3) that has not been previously treated and cannot receive standard cytarabine and anthracycline induction therapy due to age, comorbidities, or patient preference.
• Aged 60-75 years, both male and female, with an expected survival time of more than 3 months.
• Estimated creatinine clearance rate ≥ 30 mL/min.
• 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).
• ECOG Performance Status ≤ 2.
• Able to understand and voluntarily provide informed consent.

Exclusion criteria

• Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16).
• Active central nervous system leukemia.
• History of myeloproliferative neoplasms (MPN), including myelofibrosis, primary thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, and AML with BCR-ABL1 translocation.
• HIV-positive patients and/or active HBV or HCV infection (as documented by positive HBV-DNA and HCV-RNA tests).
• 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.
• Active, uncontrolled severe infection.
• History of other malignancies within the past 2 years, except for adequately treated in situ carcinoma of the cervix or breast; skin basal cell carcinoma or localized squamous cell carcinoma of the skin.
• White blood cell count > 25 x 10\^9/L. (This criterion can be met with hydroxyurea or leukapheresis.)
• Mental impairment that would compromise the ability to participate in the study.
• Any other situation in which the investigator believes that it would not be in the best interest of the patient to participate in the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Xiamen University — Xiamen

Identifiers

NCT: NCT06651866 · XMDYYYXYK-14

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗