Combination treatment for elderly patients with untreated acute myeloid leukemia

A Multicenter, Prospective, Single-arm Clinical Study of Veneclax, Chidaniline Combined With Azacitidine (VCA) Followed by Decitabine + MAG Regimen (D-MAG) in the Treatment of Elderly Untreated Acute Myeloid Leukemia (AML)

This study is testing a new combination treatment for older patients with untreated acute myeloid leukemia to see if it can help them when standard chemotherapy isn't an option.

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: NCT06827899 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a combination treatment involving veneclax, chidaniline, and azacitidine, followed by a regimen of decitabine and MAG in elderly patients diagnosed with untreated acute myeloid leukemia (AML). It is a multicenter, prospective, single-arm study designed to assess the safety and efficacy of this novel treatment approach. The trial aims to provide an alternative for patients who cannot undergo standard chemotherapy due to age or other health conditions. Participants will be closely monitored for treatment response and side effects throughout the study.

Who should consider this trial

Good fit: Ideal candidates for this study are elderly patients aged 60 and above with histologically confirmed acute myeloid leukemia who have not received prior treatment.

Not a fit: Patients with acute promyelocytic leukemia or those with low-risk cytogenetics may not benefit from this study.

Why it matters

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

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating AML, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed acute myeloid leukemia (non-M3). Have not received treatment before and cannot accept standard cytarabine and anthracycline induction regimen treatment due to age or comorbidity or patient preference;
2. Age \>= 60 years old, male or female, expected survival time greater than 3 months;
3. Estimated creatinine clearance \>= 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 \<= 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. A history of myeloproliferative neoplasms (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myelogenous 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 tests);
5. Suffering from chronic respiratory diseases requiring continuous oxygen inhalation, or having an obvious history of kidney, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases;
6. Suffering from malabsorption syndrome or other diseases that exclude the enteral route of administration;
7. Clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, myocardial infarction, and congestive heart failure within one year before enrollment patients, and patients with coronary heart disease who have clinical symptoms and need drug treatment;
8. Active, uncontrolled severe infection;
9. There is a history of other malignant tumors within 2 years, except for the following cases: adequately treated carcinoma in situ of the cervix or carcinoma in situ of the breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
10. White blood cell count \> 25 x 10\^9/L (hydroxyurea or leukapheresis can meet this standard);
11. Mental disorders that will hinder research participation;
12. Participants have received the following treatments: hypomethylation agents, venetoclax 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 — The First Aiffiliated hosptical of xiamen University
• Study coordinator: Bing Xu

Conditions Acute Myeloid Leukemia