ABC Maintenance Therapy for AML

N/ANot Yet RecruitingNCT07521124

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Acute Myeloid Leukemia (AML) in Remission

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients aged 18 to 80 years with newly diagnosed Acute Myeloid Leukemia (AML) 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3. 4. Women of childbearing potential are eligible if they meet the following conditions: 1. A negative serum or urine pregnancy test is performed within 10-14 days prior to enrollment, and a second negative pregnancy test is performed within 24 hours prior to the initiation of treatment. Both negative results are required to meet the criteria for treatment initiation. 2. 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. 5. 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. 6. Women of childbearing potential must comply with scheduled pregnancy tests. 7. Ability to understand and sign the Informed Consent Form (ICF). Exclusion Criteria: 1. Diagnosis of Acute Promyelocytic Leukemia (APL) or FAB subtype M3 AML. 2. Patients with a history of extramedullary leukemia, unless central nervous system (CNS) involvement is controlled. 3. Laboratory values that do not meet the following criteria: Total Bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); Serum Creatinine ≤ 2.5 × ULN; Absolute Neutrophil Count (ANC) \> 0.5 × 10⁹/L; Platelet Count ≥ 30 × 10⁹/L. 4. Uncontrolled comorbidities, including but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina, arrhythmia, or psychiatric illness/social situations that would compromise compliance with the protocol. 5. History of AML that was refractory to or did not achieve remission with prior treatment containing Venetoclax, Chidamide, or Azacitidine. 6. History of hypersensitivity to any component of the study protocol. 7. Pregnant women. 8. Patients with active Central Nervous System (CNS) disease. 9. Patients with Relapsed or Refractory (R/R) AML. 10. Patients who have undergone Hematopoietic Stem Cell Transplantation (HSCT).

Outcomes

Primary Outcomes

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. Hematologic Relapse: The patient shows definitive evidence of AML recurrence (e.g., blast count \> 5% in bone marrow, or reappearance of blasts in peripheral blood). 2. Death: The patient dies due to any cause while in remission.

Time frame: 1-year RFS rate

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 2-year

ABC Maintenance Therapy for AML

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts