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NCT Number: NCT05029141

New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

This study is to investigate the therapeutic efficacy and side effect of chidamide, azacitidine combined with priming HAG regimen for relapsed or refractroy acute myeloid leukemia

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Refractory Acute Leukemia Relapsed Adult AML

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged ≥ 18 and ≤ 70 years
  • Patients diagnosed with AML according to 2016 WHO myeloid malignant disease diagnosis standard (Non-APL)
  • Patients with AML must meet one of the following criteria, A or B:

A: Refractory AML disease was defined as follows: (1) failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI) < 50% and > 20% after 1 course of standard or intensive induction therapy. B: Relapsed AML disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse.

  • ECOG performance status score less than 3
  • Expected survival time ˃ 3 months
  • Patients without serious heart, lung, liver, or kidney disease
  • Ability to understand and voluntarily provide informed consent

Exclusion criteria

  • Patients who are allergic to the study drug or drugs with similar chemical structures
  • Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception
  • Active infection
  • Active bleeding
  • Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment
  • Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met
  • Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the normal range, ALT/AST > 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine > 1.5 times the upper limit of the normal value)
  • Patients with a history of clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment
  • Surgery on the main organs within the past six weeks
  • Drug abuse or long-term alcohol abuse that would affect the evaluation results
  • Patients who have received organ transplants (excepting bone marrow transplantation)
  • Patients not suitable for the study according to the investigator's assessment

Treatment and study plan

CAHAG regimen

Drug

Chidamide 30mg orally twice every week for 2 weeks on days 1, 4, 8, 11, azacytidine 75mg/m2 intravenously daily for 7 days (d3-d9) and HAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 3-16; homoharringtonine, 1mg/m2 intravenously every day on days 3-16; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily from days 2 to neutral granulocyte recovery. (when WBC > 20×10E9/L, G-CSF paused).

One treatment cycle for 28 days, a total of 2 cycles. If the bone marrow assessment is MLFS on the 28th day in the first cycle, the second cycle of treatment will be started after NE<1.0×10E9/L; if the delay exceeds 2 weeks, the patient needs to withdraw from the trial.

Placebo Regimen

Drug

Chidamide 0mg orally twice every week for 2 weeks on days 1, 4, 8, 11, azacytidine 75mg/m2 intravenously daily for 7 days (d3-d9) and HAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 3-16; homoharringtonine, 1mg/m2 intravenously every day on days 3-16; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily from days 2 to neutral granulocyte recovery. (when WBC > 20×10E9/L, G-CSF paused).

One treatment cycle for 28 days, a total of 2 cycles. If the bone marrow assessment is MLFS on the 28th day in the first cycle, the second cycle of treatment will be started after NE<1.0×10E9/L; if the delay exceeds 2 weeks, the patient needs to withdraw from the trial.

Primary outcomes

  1. Overall response rate (ORR)

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    The overall response (completed remission without minimal residual disease, completed remission with incomplete blood count recovery, morphologic leukemia-free state and partial remission) rate achieved after one or two courses(28 days) induction therapy by CAHAG regimen.

  2. Complete remission without minimal residual disease (CR with MRD-)

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    If studied pretreatment, CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC

  3. Complete remission with incomplete hematologic recovery (CRi)

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    All CR criteria except for residual neutropenia (,1.0*10E9/L [1000/uL]) or thrombocytopenia (<100*10E9/L [100 000/uL])

  4. Morphologic leukemia-free state (MLFS)

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    Bone marrow blasts ,5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required

  5. Partial remission (PR)

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.

Secondary outcomes

  1. Duration of Response (DOR)

    Time frame: 1 year

    It is measured the time from initial response to subsequent disease progression or relapse.

  2. Overall Survival (OS)

    Time frame: 1 year

    It is measured from the time of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.

  3. Progression-Free Survival (PFS)

    Time frame: 1 year

    It is measured from the time from randomization to progression or death.

Other outcomes

  1. Adverse reactions in hematology

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    Record of adverse events in hematological system during and after CAHAG regimen induction (agranulocytosis days, PLT/RBC transfusion units).

  2. Nonhematological adverse reactions

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    Record of adverse events in other organs or systmes during and after CAHAG regimen induction (infection and organ injury).

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • Anhui Provincial Hospital
  • First Affiliated Hospital of Harbin Medical University
  • Fujian Medical University Union Hospital
  • Nanfang Hospital, Southern Medical University
  • Qilu Hospital of Shandong University
  • Ruijin Hospital
  • Shandong Provincial Hospital
  • The First Hospital of Jilin University
  • West China Hospital
  • Xinqiao Hospital of Chongqing
  • Zhengzhou University

Registry information

Official study title

A Multi-center, Randomized Clinical Trial of Chidamide Combined With Azacytidine and the HAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia Patients

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Aug 31, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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