Treatment for elderly patients with newly diagnosed acute myeloid leukemia
Venetoclax Combining Chidamide and Azacitidine (VCA) Regimen Followed by Dicitabine Combined With Liposome Mitoxantrone, Cytarabine, and G-CSF (D-MAG) Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) : A Multicenter, Prospective, Single Arm Clinical Trial
This study is testing a new treatment plan for older patients with newly diagnosed acute myeloid leukemia to see if it can help them do better without the harsh side effects of standard chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT05603884 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of a treatment regimen combining Venetoclax, Chidamide, and Azacitidine (VCA) followed by a D-MAG regimen in elderly patients with newly diagnosed acute myeloid leukemia (AML). The approach aims to improve outcomes for patients who are unable to tolerate standard chemotherapy due to age or comorbidities. The study will involve administering two cycles of the VCA regimen followed by two cycles of the D-MAG regimen, with the goal of enhancing event-free survival. The regimen is designed to be more tolerable for elderly patients while aiming for higher complete response rates.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 60 and above with newly diagnosed acute myeloid leukemia who cannot receive standard chemotherapy.
Not a fit: Patients with acute promyelocytic leukemia or those with certain low-risk cytogenetic profiles may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for elderly patients with AML.
How similar studies have performed: Other studies have shown promising results with similar treatment approaches, particularly in improving outcomes for elderly AML patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\) Histologically confirmed acute myeloid leukemia (non-M3). Treatment-na?ve and unable to receive standard cytarabine and anthracycline induction regimens due to age or comorbidities or patient preference. 2\) Age ≥ 60 years old, male or female, with an expected survival more than 3 months. 3\) Estimated creatinine clearance ≥ 30 mL/min. 4) AST and ALT ≤ 3.0 x ULN (unless leukemic organ involvement). Bilirubin ≤ 1.5 x ULN (unless considered due to leukemic organ involvement). 5\) ECOG ≤ 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 neoplasm (MPN) including myelofibrosis, essential 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 HBV or HCV active infection (documented by HBV-DNA and HCV-RNA positive test) 5) Patients suffering from chronic respiratory diseases that require continuous oxygen inhalation, or a history of obvious renal, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases 6) Patients suffering from malabsorption syndrome or other conditions that exclude enteral route of administration. 7\) Patients has clinically significant QTc prolongation (\>450 ms in men; \>470 ms in women), ventricular tachycardia and atrial fibrillation, second-degree heart block, myocardial infarction within the year prior to enrollment, and congestive heart failure;and patients with coronary heart disease with clinical symptoms requiring drug treatment. 8\) Active, uncontrolled severe infection. 9) History of other malignancies within 2 years, except for the following: Adequately treated cervix or breast cancer in situ; Basal cell cancer or local squamous cell carcinoma of the skin; 10) White blood cell count \> 25 × 10\^9/L. (Hydroxyurea or leukapheresis may meet this criterion.) 11) Mental disorders that hinder research participation 12) Participants have received the following treatments: hypomethylating agents, veneclax and/or chemotherapy for myelodysplastic syndrome (MDS), solid organ transplantation. 13\) Any other circumstances that the investigator believes that the patient is not suitable to participate in this trial
Where this trial is running
Xiamen, Fujian
- Bing Xu — Xiamen, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Bing Xu, M.D. — The First Affiliated Hospital of Xiamen University
- Study coordinator: Bing Xu, M.D.
- Email: xubingzhangjian@126.com
- Phone: +865922137255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.