Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Air Force Medical Center of PLA | UNKNOWN |
| PLA Strategic Support Force's Characteristic Medical Center | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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 Participants who do not achieve at least a partial response after the first cycle may be withdrawn from the study to receive alternative treatment as recommended by clinical guidelines.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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax Combined with CACAG Regimen | Experimental | Participants assigned to Venetoclax Combined with CACAG Regimen will receive a combination regimen consisting of venetoclax plus the CACAG. The CACAG regimen includes azacitidine administered at a dose of 75 mg/m² subcutaneously on days 1-7; cytarabine given at a dose of 75-100 mg/m² q12h intravenously on days 1-5; aclarubicin administered at a dose of 20 mg intravenously on days 1, 3, and 5; and chidamide given orally at a dose of 30 mg twice a week for two weeks. 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. Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery. Each treatment cycle lasts 4-5 weeks, with a total of 2 cycles. |
|
| Standard "3+7" Regimen | Active Comparator | Participants assigned toStandard "3+7" Regimen will receive the standard "3+7" induction regimen. Daunorubicin is administered intravenously at a dose of 60 mg/m² on days 1-3. Cytarabine is given intravenously at a dose of 75-100 mg/m² twice daily on days 1-7. Each treatment cycle lasts 4-5 weeks, with a total of 2 cycles. Participants who do not achieve at least a partial response after the first cycle will be withdrawn from the study and receive alternative treatment according to clinical guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CACAG+VEN | Drug | Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite 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). | At the end of Cycle 2 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liping Dou, Doctor | Contact | +8613681207138 | lipingruirui@163.com | |
| Daihong Liu, Doctor | Contact | +8613681171597 | daihongrm@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liping Dou, Doctor | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Air Force Medical Center, PLA | Recruiting | Beijing | China |
Not provided
| ID | Term |
|---|---|
| D007948 | Leukemia, Monocytic, Acute |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 3+7 | Drug | 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. |
|
| 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). | 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). | At the end of Cycle 1 (each cycle is 28 days) |
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | Up to 12 months after enrollment |
| Adverse reactions in hematology | Record of adverse events in hematological system during and after treatment | 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 | At the end of Cycle 2 (each cycle is 28 days) |
| Chinese PLA General Hospital | Recruiting | Beijing | China |
|
| PLA Strategic Support Force's Characteristic Medical Center | Recruiting | Beijing | China |
|
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |