Testing a new treatment for elderly patients with acute myeloid leukemia

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

This study is testing a new treatment for older patients with acute myeloid leukemia to see if it is safe and effective for those who can't have the usual therapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 60 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Xiamen University (Academic / other)
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT06651866 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of a new treatment regimen, D-CMG, which combines liposomal mitoxantrone hydrochloride, cytarabine, and decitabine for elderly patients newly diagnosed with acute myeloid leukemia (AML). The study will focus on determining the maximum tolerated dose (MTD) and observing any dose-limiting toxicities (DLT) associated with this treatment. Eligible participants are those aged 60-75 who cannot receive standard induction therapy due to various factors. The trial will provide insights into a potentially safer treatment option for this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates for this study are elderly patients aged 60-75 with newly diagnosed acute myeloid leukemia who cannot receive standard induction therapy.

Not a fit: Patients with acute promyelocytic leukemia or those with active central nervous system leukemia will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for elderly patients with AML who are unable to tolerate standard therapies.

How similar studies have performed: While there have been studies on AML treatments, this specific combination regimen is novel and has not been extensively tested in this patient population.

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.

Where this trial is running

Xiamen, Fujian

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)

Study contacts

• Principal investigator: Bing Xu — The First Aiffiliated hosptical of xiamen University
• Study coordinator: Bing Xu

Conditions Acute Myeloid Leukemia