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NCT Number: NCT06651866

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

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

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

Location status: Recruiting

Location contact

Bing Xu, phD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

D-CMG

Drug

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.

Primary outcomes

  1. Maximum tolerated dose (MTD)

    Time frame: Up to 24 months

    Defined as the highest dose at which less than 2 out of 6 (ie. 33%) participants experience a Dose-Limiting Toxicity (DLT).

Secondary outcomes

  1. Complete Response Rate (CR)

    Time frame: Up to 24 months

    The percent of participants with morphologic complete remission (CR) according to modified International Working Group Acute Myeloid Leukemia Response Criteria (IWG AML)

  2. Complete Response with incomplete blood count recovery (CRi)

    Time frame: Up to 24 months

    Meets all CR criteria, except for residual neutropenia < 1,000/µL or hrombocytopenia < 100,000/µL. Dependence on red blood cell (RBC) transfusions is also defined as CRi.

  3. Disease free survival (DFS)

    Time frame: Up to 24 months

    Applies only to patients who achieve CR or CRi. It is measured from the date of remission to the date of relapse or death from any cause.

  4. Overall survival (OS)

    Time frame: Up to 24 months

    Time from the start of the patient's initial treatment to the time of death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Bing Xu

CONTACT

[email protected]

18750918842

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 22, 2024
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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