This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.
This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia. A total of 204 participants, aged 14 to 60 years, will be enrolled across multiple study sites in China. Participants will be randomly assigned to one of two treatment groups: Group 1: Venetoclax combined with the CACAG (cytarabine, azacitidine, chidamide, aclarubicin and granulocyte colony-stimulating factor) regimen This group will receive a combination of azacitidine, cytarabine, aclarubicin, chidamide, and venetoclax, along with granulocyte colony-stimulating factor (G-CSF) support. Group 2: The standard "3+7" regimen This group will receive standard induction chemotherapy with daunorubicin and cytarabine. The total study treatment period is about 8-10 weeks, consisting of two treatment cycles. Participants who do not achieve at least a partial response after the first cycle may be withdrawn from the study to receive alternative treatment as recommended by clinical guidelines. The main goal of the study is to evaluate and compare the effectiveness of these two regimens in treating acute monocytic leukemia. Outcomes will include treatment response, safety, and overall patient outcomes during the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor 1. Azacytidine (75 mg/m2/day, days 1 to 7). 2. Cytarabine (75-100 mg/m2 every 12 hrs, days 1 to 5). 3. Aclacinomycin (20 mg/day, days 1,3,5). 4. Chidamide (30 mg/day , days 1,4,8,11). 5. Venetoclax is administered orally with a dose ramp-up schedule: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3 through 14. If an azole antifungal agent is co-administered, the dose of venetoclax is reduced to 100 mg daily. 6.Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery.
IA regimen: 1. Idarubicin (8-10 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. DA regimen: 1.Daunorubicin(60 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. MA regimen: 1.Mitoxantrone (12 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
Air Force Medical Center, PLA
Beijing, China
RECRUITINGChinese PLA General Hospital
Beijing, China
RECRUITINGPLA Strategic Support Force's Characteristic Medical Center
Beijing, China
RECRUITINGComposite Complete Remission Rate
Proportion of participants achieving composite complete remission (CRc = CR + CRi) after one cycle of treatment. CR is defined as no clinical leukemic symptoms, hemoglobin ≥100 g/L (male) or ≥90 g/L (female/children), ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, no blasts in peripheral blood, and bone marrow blasts ≤5% with normal erythroid and megakaryocytic lineages. CRi meets all CR criteria except residual neutropenia (ANC \<1.0×10⁹/L) or thrombocytopenia (platelets \<100×10⁹/L).
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Complete Remission Rate after Cycle 1
Proportion of participants achieving complete remission (CR) after one cycle of treatment. CR is defined as absence of clinical symptoms and signs of leukemic infiltration; hemoglobin ≥100 g/L (male) or ≥90 g/L (female and children), absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, no blasts in peripheral blood differential, and bone marrow blasts (type I + II) ≤5% with normal erythroid and megakaryocytic lineages.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Complete Remission with Incomplete Count Recovery Rate after Cycle 1
Proportion of participants achieving complete remission with incomplete count recovery (CRi) after one cycle of treatment. CRi is defined as meeting all CR criteria except for residual neutropenia (absolute neutrophil count \<1.0×10⁹/L) or thrombocytopenia (platelet count \<100×10⁹/L).
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Overall Response Rate after Cycle 1
Proportion of participants achieving overall response after one cycle of treatment. Overall response is defined as the sum of complete remission (CR), complete remission with incomplete count recovery (CRi), and partial remission (PR).
Time frame: At the end of Cycle 1 (each cycle is 28 days)
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Partial Remission Rate after Cycle 1
Proportion of participants achieving partial remission (PR) after one cycle of treatment. PR is defined as a reduction of bone marrow blasts by more than 50%, with a final blast percentage between 5% and 25%, and recovery of peripheral blood counts to normal.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Minimal Residual Disease Negative Rate after Cycle 1
Proportion of participants achieving minimal residual disease (MRD) negativity after one cycle of treatment. MRD negativity is defined as the absence of measurable residual disease as assessed by immunologic or molecular methods.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Composite Complete Remission Rate after Cycle 1
Proportion of participants achieving composite complete remission (CRc = CR + CRi) after two cycles of treatment.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Complete Remission Rate after Cycle 2
Proportion of participants achieving complete remission (CR) after two cycles of treatment. CR is defined as absence of clinical symptoms and signs of leukemic infiltration; hemoglobin ≥100 g/L (male) or ≥90 g/L (female and children), absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, no blasts in peripheral blood differential, and bone marrow blasts (type I + II) ≤5% with normal erythroid and megakaryocytic lineages.
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Complete Remission with Incomplete Count Recovery Rate after Cycle 2
Proportion of participants achieving complete remission with incomplete count recovery (CRi) after two cycles of treatment. CRi is defined as meeting all CR criteria except for residual neutropenia (absolute neutrophil count \<1.0×10⁹/L) or thrombocytopenia (platelet count \<100×10⁹/L).
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Partial Remission Rate after Cycle 2
Proportion of participants achieving partial remission (PR) after two cycles of treatment. PR is defined as a reduction of bone marrow blasts by more than 50%, with a final blast percentage between 5% and 25%, and recovery of peripheral blood counts to normal.
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Minimal Residual Disease Negative Rate after Cycle 2
Proportion of participants achieving minimal residual disease (MRD) negativity after two cycles of treatment. MRD negativity is defined as the absence of measurable residual disease as assessed by immunologic or molecular methods.
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Progression-Free Survival
The time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first. Disease progression is defined according to standard criteria for acute monocytic leukemia.
Time frame: Up to 12 months after enrollment
Overall Survival
The time from enrollment to death from any cause. For surviving participants, data will be censored at the date of last follow-up.
Time frame: Up to 12 months after enrollment
Relapse Rate
The proportion of participants who achieve remission (CR or CRi) and subsequently experience disease relapse during the follow-up period. Relapse is defined according to standard criteria for acute monocytic leukemia.
Time frame: Up to 12 months after enrollment
Duration of Remission
The time from the first documented remission (CR or CRi) to disease relapse or death from any cause, whichever occurs first.
Time frame: Up to 12 months after enrollment
Adverse reactions in hematology
Record of adverse events in hematological system during and after treatment
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Nonhematological adverse reactions
Record of adverse events in other organs or systmes during and after treatment
Time frame: At the end of Cycle 2 (each cycle is 28 days)