Decitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04373395
• Other study ID #: D-CLAG-ZJU
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: September 2020
• Source: Zhejiang University
• Contact: Yongxian Hu
• Phone: +86-0571-87236476
• Email: huyongxian2000[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Procedure:
• D-CLAG
Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor

Locations

Country	Name	City	State
China	the First Affiliated Hospital,School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (12)

Lead Sponsor

Collaborator

Zhejiang University

Chia Tai Tianqing Pharmaceutical Group Co., Ltd., First Affiliated Hospital of Wenzhou Medical University, First People's Hospital of Hangzhou, Hanhui Pharmaceuticals CO., LTD, Huizhou Municipal Central Hospital, Jinhua Central Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sir Run Run Shaw Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, Zhejiang Provincial People's Hospital, Zhejiang Provincial Tongde Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission (CR) rate	Complete remission rate after 1 course of D-CLAG regimen	Complete blood count recovery or 1 month after 1 course of D-CLAG regimen