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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2023
  • participants needed
    65
  • sponsor
    Zhejiang University
Updated on 5 March 2022
cancer
remission
acute leukemia
cytarabine
ejection fraction
granulocyte colony stimulating factor
decitabine
idarubicin
refractory acute myeloid leukemia (aml)
acute promyelocytic leukemia
blast cells
cladribine
colony stimulating factor

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
Treatment D-CLAG
Clinical Study IdentifierNCT04373395
SponsorZhejiang University
Last Modified on5 March 2022

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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