Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Azacitidine

Lenograstim

Homoharringtonine

The patients are randomized into the group. Patients whose last induction failure regimen is a demethylated agent combined with priming regimen enter the experimental group directly.

The patients are randomized into the group.

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.

CAHAG regimen

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.

Placebo regimen

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

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

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

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

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

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.

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

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

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

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%.

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

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.

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

Ruijin Hospital

West China Hospital

Fujian Medical University Union Hospital

The First Hospital of Jilin University

Anhui Provincial Hospital

Qilu Hospital of Shandong University

The Affiliated Cancer Hospital of Zhengzhou University

Shandong Provincial Hospital

Nanfang Hospital, Southern Medical University

First Affiliated Hospital of Harbin Medical University

Xinqiao Hospital of Chongqing

The First Affiliated Hospital of Soochow University

accociate professor

Decitabine

Idarubicin

Relapsed or refractroy acute myeloid leukemia patients reveive chidamide, decitabine combined with priming IAG regimen treatment.

Chidamide 30mg orally twice every week for 2 weeks on days 1, 4, 8, 11, decitabine 20mg/m2 intravenously daily for 5 days (d1-d5) and IAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 4-17; idarubicin, 5mg intravenously every other day on days 4, 6, 8, 10, 12, 14; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily on days 3-17.

CDIAG regimen

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

CDIAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Chidamide, Decitabine Combined With Priming IAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Remission rate achieved after one-two couses induction therapy by CDIAG regimen

It is measured from the date 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.

Record of adverse events in hematological system during and after CDIAG regimen induction

Record of adverse events in other organs or systmes during and after CDIAG regimen induction

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia	NCT05029141	Acute Myeloid L... Refractory Acut... Relapsed Adult ...	CAHAG regimen Placebo regimen	18 Years - 69 Years	The First Affiliated Hospital of Soochow University
CDIAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia	NCT03985007	Acute Myeloid L...	CDIAG regimen	18 Years - 70 Years	The First Affiliated Hospital of Soochow University

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