Decitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCT ID: NCT04373395
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
65 participants
INTERVENTIONAL
2020-01-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia
NCT03181815
A Multicenter Prospective Cohort Study Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure
NCT05875649
the Efficacy and Safety of CLAE in R/R T-ALL/LBL
NCT04679506
CLL-1/CD33 Targeted LCAR-AMDR Cells in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT05654779
Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia
NCT03441048
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
D-CLAG
Administration of D-CLAG regimen (Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor)
D-CLAG
Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
D-CLAG
Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Sir Run Run Shaw Hospital
OTHER
Zhejiang Provincial People's Hospital
OTHER
First People's Hospital of Hangzhou
OTHER
Zhejiang Provincial Tongde Hospital
OTHER
Jinhua Central Hospital
OTHER
Huizhou Municipal Central Hospital
OTHER
The Sixth Affiliated Hospital of Wenzhou Medical University
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Hanhui Pharmaceutical Co., Ltd
INDUSTRY
Zhejiang University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
He Huang
President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
the First Affiliated Hospital,School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D-CLAG-ZJU
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.