Clinical trial NCT04373395: Decitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myeloid Leukemia
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Sir Run Run Shaw Hospital
name: Zhejiang Provincial People's Hospital
name: First People's Hospital of Hangzhou
name: Zhejiang Provincial Tongde Hospital
name: Jinhua Central Hospital
name: Huizhou Municipal Central Hospital
name: The Sixth Affiliated Hospital of Wenzhou Medical University
name: First Affiliated Hospital of Wenzhou Medical University
name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
name: Hanhui Pharmaceutical Co., Ltd
First posted: 2020-05-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Complete remission (CR) rate
timeFrame: Complete blood count recovery or 1 month after 1 course of D-CLAG regimen
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital,School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: