Status:
UNKNOWN
Decitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sir Run Run Shaw Hospital
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04373395
Start Date
January 1 2020
End Date
December 1 2023
Last Update
September 16 2020
Active Locations (1)
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1
the First Affiliated Hospital,School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003