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

Not Applicable

• Conditions: Acute Myeloid Leukemia
• Interventions: Procedure: D-CLAG

• Registration Number: NCT04373395
• Lead Sponsor: Zhejiang University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-05-04
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-12
• Last Update Posted: 2020-09-16
• Primary Completion: 2021-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
D-CLAG	D-CLAG	Administration of D-CLAG regimen (Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

the First Affiliated Hospital,School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China