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

Zhejiang University

Status

Unknown

Conditions

Acute Myeloid Leukemia

Treatments

Procedure: D-CLAG

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04373395

D-CLAG-ZJU

Details and patient eligibility

About

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

Enrollment

65 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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 ≤2×ULN.
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.