Back to resultsDecitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)
Primary Purpose
Acute Myeloid Leukemia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
D-CLAG
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- the First Affiliated Hospital,School of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
D-CLAG
Arm Description
Administration of D-CLAG regimen (Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor)
Outcomes
Primary Outcome Measures
Complete remission (CR) rate
Complete remission rate after 1 course of D-CLAG regimen
Secondary Outcome Measures
Full Information
NCT ID
NCT04373395
First Posted
April 29, 2020
Last Updated
September 12, 2020
Sponsor
Zhejiang University
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT04373395
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
D-CLAG
Arm Type
Experimental
Arm Description
Administration of D-CLAG regimen (Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor)
Intervention Type
Procedure
Intervention Name(s)
D-CLAG
Intervention Description
Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor
Primary Outcome Measure Information:
Title
Complete remission (CR) rate
Description
Complete remission rate after 1 course of D-CLAG regimen
Time Frame
Complete blood count recovery or 1 month after 1 course of D-CLAG regimen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongxian Hu
Phone
+86-0571-87236476
Email
huyongxian2000@aliyun.com
Facility Information:
Facility Name
the First Affiliated Hospital,School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongxian Hu, Dr
Phone
15957162012
Email
huyongxian2000@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
Decitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)
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