NCT04373395

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.9 years

First QC Date

April 29, 2020

Last Update Submit

September 12, 2020

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

D-CLAG

EXPERIMENTAL

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

Procedure: D-CLAG

Interventions

D-CLAGPROCEDURE

Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor

D-CLAG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital,School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Yongxian Hu

CONTACT

+86-0571-87236476huyongxian2000@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of The First Affiliated Hospital, College of Medicine, Zhejiang University

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 4, 2020

Study Start

January 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2023

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

CN(1)