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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

September 1, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

August 31, 2027

Conditions
Acute Myeloid LeukemiaRefractory Acute LeukemiaRelapsed Adult AML
Interventions
DRUG

CAHAG regimen

"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."

DRUG

Placebo 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."

Trial Locations (1)

215006

The First Affliated Hospital of Soochow University, Suzhou

All Listed Sponsors
collaborator

Ruijin Hospital

OTHER

collaborator

West China Hospital

OTHER

collaborator

Fujian Medical University Union Hospital

OTHER

collaborator

The First Hospital of Jilin University

OTHER

collaborator

Anhui Provincial Hospital

OTHER_GOV

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

The Affiliated Cancer Hospital of Zhengzhou University

UNKNOWN

collaborator

Shandong Provincial Hospital

OTHER_GOV

collaborator

Nanfang Hospital, Southern Medical University

OTHER

collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

collaborator

Xinqiao Hospital of Chongqing

OTHER

lead

The First Affiliated Hospital of Soochow University

OTHER