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

Last updated: February 21, 2025
Sponsor: The First Affiliated Hospital of Xiamen University
Overall Status: Active - Recruiting

Phase

1

Condition

Acute Myeloid Leukemia

Platelet Disorders

Leukemia

Treatment

D-CMG

Clinical Study ID

NCT06651866
XMDYYYXYK-14
  • Ages 60-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed acute myeloid leukemia (non-M3) that has not beenpreviously treated and cannot receive standard cytarabine and anthracyclineinduction 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

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, primarythrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or withoutBCR-ABL1 translocation, and AML with BCR-ABL1 translocation.

  4. HIV-positive patients and/or active HBV or HCV infection (as documented by positiveHBV-DNA and HCV-RNA tests).

  5. Clinically significant QTc prolongation (men > 450 ms; women > 470 ms), ventriculartachycardia, atrial fibrillation, second-degree heart block, history of myocardialinfarction within the past year, congestive heart failure, and coronary arterydisease requiring medication.

  6. Active, uncontrolled severe infection.

  7. History of other malignancies within the past 2 years, except for adequately treatedin situ carcinoma of the cervix or breast; skin basal cell carcinoma or localizedsquamous cell carcinoma of the skin.

  8. White blood cell count > 25 x 10^9/L. (This criterion can be met with hydroxyurea orleukapheresis.)

  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 thebest interest of the patient to participate in the trial.

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: D-CMG
Phase: 1
Study Start date:
December 12, 2024
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361000
    China

    Active - Recruiting

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