Testing a new treatment for elderly patients with acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: xubingzhangjian@126.com
• Phone: 18750918842

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tailored exercise program to improve quality of life for adults with hematologic cancers

  This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.

  Recruiting Gruppo Italiano Malattie EMatologiche dell'Adulto · Roma, Rm and 2 other locations · NCT07912684

• Characterization of CD180 Protein Expression in Myeloid Blood C cancers

  This study tests how CD180 is presented on myeloid cancer cells and normal stem cells using existing patient samples from AML cases to see if it could help with diagnosis or monitoring.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07895901

• Personalized AML: Find biomarkers to predict response to venetoclax

  This study tests whether single-cell analyses can help group AML patients by biology and find biomarkers that predict who will respond to venetoclax.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan · NCT07874100

• Low-dose Liposomal Amphotericin B for preventing fungal infections in adults with blood cancers and prolonged neutropenia

  This study tests whether giving a daily 50 mg dose of liposomal amphotericin B can help prevent invasive fungal infections in adults with blood cancers who have prolonged low white blood cell counts.

  Recruiting Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Hainan, Hainan · NCT07763054

• MAX-40279 with Venetoclax and Azacitidine for unfit newly diagnosed AML

  This study tests MAX-40279 added to venetoclax and azacitidine in older or unfit adults newly diagnosed with AML to see if it is safe and shows activity.

  Recruiting Phase 2 Maxinovel Pty., Ltd. · Tianjin · NCT07743112

• Venetoclax and Azacitidine Consolidation After Remission in Intermediate-Risk AML

  We’re testing if a venetoclax-plus-azacitidine consolidation approach works as well as standard high-dose chemotherapy for adults with intermediate-risk AML who have already achieved remission and are headed to stem cell transplant.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07672262

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.