Study of Azacitidine Combined With Homoharringtonie Based Regimens in AML

  • STATUS
    Recruiting
  • days left to enroll
    7
  • participants needed
    47
  • sponsor
    Ge Zheng
Updated on 25 January 2021
cytarabine
filgrastim
granulocyte colony stimulating factor
daunorubicin
idarubicin
azacitidine
cytarabine/daunorubicin
colony stimulating factor

Summary

Rencent years have witnessed great progress of the treatment of acute myeloid leukemia. However, most patients have poor outcomes following the currently first-line DA(daunorubicin, cytarabine)/IA(Idarubicin, cytarabine) chemotherapy, espiecially for the older patients and those not eligiable for receiving allo-HSCT. Azacitidine (AZA) was listed to methylation of drugs in China in 2018, is currently the only one approved methylation drugs in the treatment of AML(acute myeloid leukemia), in the NCCN guidelines. The homoharringtonie could induce AML(acute myeloid leukemia) cell lines and primary myeloid leukemia cell apoptosis, and the effect was dose dependent. While, HHT could also induce leukemia cells to differentiate into normal state, eventually achieve the goal of treatment, and control the disease. The investigators conducted a clinical study to evaluate the efficacy and safety of the AZA plus HAG(homoharringtonie, cytarabine, G-CSF), HIA(homoharringtonie, Idarubicin, cytarabine)/HDA(homoharringtonie, daunorubicin, cytarabine). This study is aimed to validate the efficacy and safety advantages of the regimens that cotain homoharringtonie and azacitidine, and to determine which regimen would receive more living benefits.

Description

Currently, the treatment of acute myeloid leukemia still remains a therapeutic challenge. Patients received traditional chemotherapy have a low remission rate, poor prognosis and short survival period for patients. New treatment strategies are needed in find out a better chemotherapy regimen.

Azacitidine (AZA) was listed to methylation of drugs in China in 2018, is currently the only approved drug for use in acute myeloid leukemia to methylation of drugs, in the NCCN guidelines. New combinations based on the azacitidine are currently undergoing, and the preliminary results brought new hope to the treatment of AML.

The homoharringtonie was extracted from tricuspid plants of China. As a protein synthesis inhibitor, homoharringtonie plays a major role in the G1 / G2 phase in cells. In addition, it could induce AML cell lines and primary myeloid leukemia cell apoptosis, and the effect was dose dependent. Meanwhile it could also induce leukemia cells to differentiate into normal state, eventually controlled the progression of the disease.

Combination with azacitidine may become a new option.This study intends to apply azacitidine in combination with homoharringtonie for treating AML patients, aiming to improve the efficacy, reducing adverse reactions and improve the living qualities of patients.

Patients of denovo or relapsed AML(age60y) will receive AZA+HAG (homoharringtonie, cytarabine, G-CSF) regiment as induction therapy. After complete remission(CR), maintenance therapy with AZA+lenalidomide/AZA will be used every 4-6 weeks until progression or total of 12cycles.

Patients of denovo or relapsed AML(age<60y) will receive AZA +HIA(homoharringtonie, Idarubicin, cytarabine) or AZA+HDA(homoharringtonie, daunorubicin, cytarabine) regiments as introduction therapy., After CR, post-remission therapy will follow with NCCN guidelines.

The investigators choose historical AML patients receiving tranditional chemotherapy as a control group, to validate the efficacy and safety profiles.

Details
Condition Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment Azacitidine, Homoharringtonine
Clinical Study IdentifierNCT04248595
SponsorGe Zheng
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnoised with acute myeloid leukemia
Meet the criteria of the 2016 WHO classification system(APL were excluded), based on blood cell counting, bone marrow biopsy, and cytogeneic diagnosis
Volunteered to sign the informed consent

Exclusion Criteria

Mental disorders or other conditions that cannot meet the requirements of research, treatment and monitoring
Uncontrolled cardiovascular disease
Allergic to azacytarine, homoharringtonie, or other drugs of this study
Any other conditions considered by the study investgators that are not suitable for participating in this clinical trial
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