ABC Maintenance Therapy for AML

NCT07521124 | Not Yet Recruiting

• 1 other identifier: Chi-Ven(Bcl-2)-Aza
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myeloid Leukemia (AML) in Remission

Keywords

Acute Myeloid Leukemia (AML); Chidamide; ABC

Outcome Measures

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.

  1-year RFS rate

Secondary Outcomes (5)

• Overall Survival (OS)

  2-year

• Event-Free Survival (EFS)

  2-year

• Duration of Remission (CRd)

  2-year

• Safety Evaluation

  2-year

• Analysis of MRD Dynamics and Prognostic Impact

  2-year

Study Arms (2)

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.

Drug: Cohort 1 (MRD-Negative Patients): 61 subjects

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.

Drug: Cohort 2 (MRD-Persistent Positive Patients): 43 subjects

Interventions

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.

Also known as: MRD-Persistent Positive Patients

Cohort 2 (MRD-Persistent Positive Patients): 43 subjects

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.

Also known as: MRD-Negative Patients

Cohort 1 (MRD-Negative Patients): 61 subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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.
• 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).

You may not qualify if:

• 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.
• History of AML that was refractory to or did not achieve remission with prior treatment containing Venetoclax, Chidamide, or Azacitidine.
• History of hypersensitivity to any component of the study protocol.
• Pregnant women.
• Patients with active Central Nervous System (CNS) disease.
• Patients with Relapsed or Refractory (R/R) AML.
• Patients who have undergone Hematopoietic Stem Cell Transplantation (HSCT).

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Weiming Li, Ph.D.

CONTACT

027-85726375; lee937@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (1)