Veneclax, Chidaniline Combined With Azacitidine Followed by Decitabine + MAG Regimen in the Treatment of Elderly Untreated AML
Recruiting now · Phase 2
Conditions studied: Acute Myeloid Leukemia
In brief
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)
Key facts
- Study ID
- NCT06827899
- Run by
- The First Affiliated Hospital of Xiamen University
- People needed
- 66
- Starts
- 2022-07-01
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2025-02-20
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
- Age >= 60 years old, male or female, expected survival time greater than 3 months;
- Estimated creatinine clearance >= 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 <= 2;
- Able to understand and voluntarily provide informed consent.
You may not qualify if…
- Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16);
- Active central nervous system leukemia;
- 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;
- HIV-positive patients and/or HBV or HCV active infection (documented by HBV-DNA and HCV-RNA positive tests);
- 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;
- Suffering from malabsorption syndrome or other diseases that exclude the enteral route of administration;
- 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;
- Active, uncontrolled severe infection;
- 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;
- White blood cell count > 25 x 10\^9/L (hydroxyurea or leukapheresis can meet this standard);
- Mental disorders that will hinder research participation;
- Participants have received the following treatments: hypomethylation agents, venetoclax and/or chemotherapy for myelodysplastic syndrome (MDS), solid organ transplantation;
- Any other circumstances that the investigator believes that the patient is not suitable to participate in this trial.
Where it is running
- Bing Xu — Xiamen, Fujian, China (enrolling)
Full record on ClinicalTrials.gov
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