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ABC Maintenance Therapy for AML

ConditionAcute Myeloid Leukemia (AML) in Remission
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

Diagnosis of Acute Promyelocytic Leukemia (APL) or FAB subtype M3 AML.

Patients with a history of extramedullary leukemia, unless central nervous system (CNS) involvement is controlled.

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.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Cohort 1 (MRD-Negative Patients): 61 subjectsExperimental treatment 1 intervention
Group B: Cohort 2 (MRD-Persistent Positive Patients): 43 subjectsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: