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Study Objectives:
To evaluate the Relapse-Free Survival (RFS) and 1-year RFS rate in patients with Acute Myeloid Leukemia (AML) receiving maintenance therapy with Chidamide combined with Venetoclax and Azacitidine.
Study Design:
Prospective, Multicenter, Interventional Cohort Study.
Total Enrollment:
104 subjects. Cohort 1 (MRD-Negative Patients): 61 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. Cohort 2 (MRD-Persistent Positive Patients): 43 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (MRD-Negative Patients): 61 subjects | Experimental | Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. |
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| Cohort 2 (MRD-Persistent Positive Patients): 43 subjects | Experimental | Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1 (MRD-Negative Patients): 61 subjects | Drug | Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-Free Survival (RFS) | Relapse-Free Survival (RFS) is defined as the time interval from the date of enrollment (or achievement of Complete Remission) to the date of hematologic relapse, the occurrence of a second primary malignancy, or death from any cause, whichever occurs first. ● Endpoint Event: An "event" for RFS analysis is recorded when:
| 1-year RFS rate |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) is defined as the time interval from the date of enrollment (or randomization) to the date of death from any cause. Endpoint Event: The primary event for the analysis is death from any cause (whether related to the disease, treatment, or other causes). Censoring: Patients who are still alive at the time of the final data cutoff, or who are lost to follow-up, will be censored at the date of their last known contact (last known alive date). |
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Inclusion Criteria:
Patients aged 18 to 80 years with newly diagnosed Acute Myeloid Leukemia (AML)
Patients who have achieved their first Complete Remission (CR) or Complete Remission with incomplete hematologic recovery (CRi) at the time of enrollment, following induction therapy with intensive chemotherapy and at least 2 cycles of consolidation therapy. Remission must have been achieved within 4 months (±7 days) prior to enrollment.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
Women of childbearing potential are eligible if they meet the following conditions:
Male patients with female partners of childbearing potential are eligible if they agree to practice abstinence or use two effective methods of contraception during the treatment period and for 28 days after discontinuation of the study drug.
Women of childbearing potential must comply with scheduled pregnancy tests.
Ability to understand and sign the Informed Consent Form (ICF).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiming Li, Ph.D. | Contact | 027-85726375 | lee937@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog | Wuhan | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Total Enrollment:
104 subjects. Cohort 1 (MRD-Negative Patients): 61 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. Cohort 2 (MRD-Persistent Positive Patients): 43 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.
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| Cohort 2 (MRD-Persistent Positive Patients): 43 subjects | Drug | Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. |
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| 2-year |
| Event-Free Survival (EFS) | Event-Free Survival (EFS) is defined as the time interval from the date of enrollment (or start of treatment) to the date of the first occurrence of any of the following events: Relapse: Hematologic recurrence of Acute Myeloid Leukemia (e.g., reappearance of blasts in bone marrow or peripheral blood). Death: Death from any cause (whether related to the disease, treatment, or other causes). Treatment Failure: (Optional, depending on protocol strictness) Failure to achieve response, or discontinuation of treatment due to toxicity or progressive disease before relapse. Censoring: Patients who do not experience any of the above events by the time of the final data cutoff, or who are lost to follow-up, will be censored at the date of their last adequate assessment. | 2-year |
| Duration of Remission (CRd) | Duration of Remission (CRd) is defined as the time interval from the date of first documented Complete Remission (CR) (or the date of enrollment if the patient is already in CR at baseline) to the date of relapse or death from any cause, whichever occurs first. Endpoint Event: An "event" for CRd analysis is recorded when: Relapse: The patient shows definitive evidence of AML recurrence (e.g., blast count > 5% in bone marrow, or reappearance of blasts in peripheral blood). Death: The patient dies while in remission. Censoring: Patients who are still alive and have not relapsed at the time of the final data cutoff are censored at the date of their last adequate assessment. | 2-year |
| Safety Evaluation | All Adverse Events (AEs) occurring during the clinical study, including abnormal clinical symptoms, vital signs, and laboratory findings, will be described in detail. Clinical characteristics, severity, onset time, duration, management, and outcomes of these events will be recorded. The relationship between these events and the study drugs will be assessed. Hematologic and non-hematologic toxicities will be graded according to the NCI-CTCAE v5.0 criteria. | 2-year |
| Analysis of MRD Dynamics and Prognostic Impact | Evaluation of the kinetic impact of Chidamide combined with Venetoclax and Azacitidine maintenance therapy on Measurable Residual Disease (MRD) and its correlation with prognosis. | 2-year |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |