NCT05566054 Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia
| NCT ID | NCT05566054 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Acute Monocytic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2026-09-30 |
Trial Parameters
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Brief Summary
This study is to investigate the therapeutic efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly diagnosed acute monocytic leukemia patients that are ineligible for intensive chemotherapy
Eligibility Criteria
Inclusion Criteria: Confirmation of acute monocytic leukemia( AML-M5) diagnosis by the French-American-British (FAB) Classification and/or characterized for expression of monocytic and myeloid differentiation markers, have a projected life expectancy of at least 12 weeks, previously untreated, and ineligible for treatment with intensive chemotherapy. Patients must be considered ineligible for induction therapy defined by the following: 1. \>= 60 years of age 2. \>=18 to 59years of age with at least one of the following comorbidities: Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy: (A)Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3. (B)Cardiac history of congestive heart failure requiring treatment or ejection fraction \<= 50% or chronic stable angina. (C)Diffusing capacity of the lung for carbon monoxide (DLCO) \<= 65% or forced expiratory volume during the first second (FEV1) \<= 65%. (D)Creatinine clearance \>= 30
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