Clinical trial · Interventional
Veneclax, Chidaniline Combined With Azacitidine Followed by Decitabine + MAG Regimen in the Treatment of Elderly Untreated AML
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)
NCT06827899CI-TRIAL-00086262recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG)
- interventionNames
- Drug: veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG)
Primary outcomes (1)
- measure
- Event-free survival (EFS)
- timeFrame
- Up to 60 months
- description
- Defined as the time interval from treatment initiation to the occurrence of induction failure, relapse, or death, whichever came first.
Secondary outcomes (4)
- measure
- Complete Remission (CR) rate
- timeFrame
- Up to 60 months
- description
- The percent of participants with complete remission (CR) was defined in accordance with the IWG Response Criteria in AML.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.