Decitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)

  • STATUS
    Recruiting
  • participants needed
    65
  • sponsor
    Zhejiang University
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Updated on 17 February 2024
See if I qualify
cancer
remission
glomerular filtration rate
ejection fraction
myeloid leukemia
cytarabine
acute leukemia
idarubicin
granulocyte colony stimulating factor
decitabine
blast cells
nephropathy
leukemia
cladribine
colony stimulating factor
acute promyelocytic leukemia
refractory acute myeloid leukemia (aml)
clag regimen

Summary

A prospective, single-arm, multicenter, exploratory study to evaluate the efficacy and safety of D-CLAG regimen in the treatment of relapsed or refractory acute myeloid leukemia

Details
Condition Acute myeloid leukemia, Acute myeloid leukemia
Age 18years - 70years
Treatment D-CLAG
Clinical Study IdentifierNCT04373395
SponsorZhejiang University
Last Modified on17 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Acute myeloid leukemia (non-acute promyelocytic leukemia) must be diagnosed before enrollment. Diagnostic criteria refer to WHO (World Health Organization) classification
Refractory or relapsed AML: refractory is defined as the failure of CR after 2 courses of standard induced remission therapy (2 courses of idarubicin+cytarabine (IA) regimen or 1 course of IA regimen + 1 course of high dose cytarabine); Relapse is defined as the blast cells >5% in bone marrow or presence of extramedullary leukemia for patient who achieved CR before
Age 18-70
Eastern cancer cooperation group (ECOG) 2
Creatinine clearance 30 mL/min (estimated glomerular filtration rate (eGFR) according to the Cockcroft-Gault formula or Modification of Diet in Renal Disease (MDRD) formula)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 upper limit of normal range (ULN), total bilirubin 2ULN
Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)50%
Life expectancy >8 weeks
Voluntarily sign the informed consent and understand and comply with the requirements of the study

Exclusion Criteria

White blood cell (WBC) > 50 109 / L
Patients who have received salvage treatment with D-CLAG
Current active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease according to the New York heart association (NYHA) functional classification, or a history of myocardial infarction within 6 months prior to screening
Other serious diseases that may limit patient participation in the trial (e.g. progressive infections, uncontrolled diabetes)
Pregnant or nursing women
Unable to understand or follow the research protocol or unable to sign the informed consent
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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