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

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

NCT ID: NCT06651866

Condition: Acute Myeloid Leukemia

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: D-CMG
Description: 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 CR (Complete Remission) and PR (Partial Remission) in the first cycle can continue with the original dose for one more cycle, and then the investigator decides whether to continue this regimen or choose another regimen for maintenance therapy; Patients with NR (No Remission) in the first cycle will be withdrawn from this study.
Arm group label: D-CMG

Summary: 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

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. 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. 2. Aged 60-75 years, both male and female, with an expected survival time of more than 3 months. 3. Estimated creatinine clearance rate ≥ 30 mL/min. 4. 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). 5. ECOG Performance Status ≤ 2. 6. Able to understand and voluntarily provide informed consent. Exclusion Criteria: 1. Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16). 2. Active central nervous system leukemia. 3. 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. 4. HIV-positive patients and/or active HBV or HCV infection (as documented by positive HBV-DNA and HCV-RNA tests). 5. 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. 6. Active, uncontrolled severe infection. 7. 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. 8. White blood cell count > 25 x 10^9/L. (This criterion can be met with hydroxyurea or leukapheresis.) 9. Mental impairment that would compromise the ability to participate in the study. 10. 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.

Gender: All

Minimum age: 60 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: The First Affiliated Hospital of Xiamen University

Address:
City: Xiamen
Zip: 361000
Country: China

Status: Recruiting

Contact:
Last name: Bing Xu, phD
Email: xubingzhangjian@126.com

Start date: October 22, 2024

Completion date: June 30, 2027

Lead sponsor:
Agency: The First Affiliated Hospital of Xiamen University
Agency class: Other

Source: The First Affiliated Hospital of Xiamen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06651866