Acute Myeloid Leukemia
Conditions
Brief summary
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)
Detailed description
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)
Interventions
DRUGveneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG)
Specified dose on specified days
Sponsors
Fujian Provincial Hospital
Fujian Cancer Hospital
Zhangzhou Affiliated Hospital of Fujian Medical University
Jieyang People's Hospital
Huizhou Municipal Central Hospital
The First Affiliated Hospital of Xiamen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS) | Up to 60 months | Defined as the time interval from treatment initiation to the occurrence of induction failure, relapse, or death, whichever came first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission (CR) rate | Up to 60 months | The percent of participants with complete remission (CR) was defined in accordance with the IWG Response Criteria in AML. |
| Overall Survival (OS) | Up to 60 months | OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point. |
| Overall Response Rate (ORR) | Up to 60 months | Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR). |
| General Health Status/Quality of Life | Up to 60 months | Will be assessed by Questionnaire. |
Countries
China
Contacts
Primary ContactBing Xu
Backup ContactZhifeng Li
Outcome results
None listed