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

Sponsor

Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04373395

Collaborator

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 Pharmaceuticals CO., LTD (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Procedure: D-CLAG	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: D-CLAG Administration of D-CLAG regimen (Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor)	Procedure: D-CLAG Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor

Arm

Intervention/Treatment

Experimental: D-CLAG

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

Procedure: D-CLAG

Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the First Affiliated Hospital,School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

Zhejiang University
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 Pharmaceuticals CO., LTD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

He Huang, President of The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04373395

Other Study ID Numbers:

D-CLAG-ZJU

First Posted:

May 4, 2020

Last Update Posted:

Sep 16, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Sep 16, 2020