Acute Myeloid Leukemia
Conditions
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
Interventions
PROCEDURED-CLAG
Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sir Run Run Shaw Hospital
Zhejiang Provincial People's Hospital
First People's Hospital of Hangzhou
Zhejiang Provincial Tongde Hospital
Jinhua Central Hospital
Huizhou Municipal Central Hospital
The Sixth Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital of Wenzhou Medical University
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Hanhui Pharmaceutical Co., Ltd
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission (CR) rate | Complete blood count recovery or 1 month after 1 course of D-CLAG regimen | Complete remission rate after 1 course of D-CLAG regimen |
Countries
China
Contacts
Primary ContactYongxian Hu
Outcome results
None listed