NCT05875649

Brief Summary

Most of patients with acute myeloid leukemia achieved complete remission (CR) after primary induction chemotherapy, there were 20-30% patients without CR after first-induction. It was uncertain how to treat these patients. It was investigated in our study that these patients were re-induced with CLAG Regimen. The CR ratio, overall survival (OS) and relapsed-free survival (RFS) was statistically analysed in these patients.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jul 2023Dec 2027

First Submitted

Initial submission to the registry

May 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 2, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2027

Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

4.1 years

First QC Date

May 16, 2023

Last Update Submit

July 2, 2023

Conditions

AML

Keywords

CLAGacute myeloid leukemiaFirst-induction failure

Outcome Measures

Primary Outcomes (1)

  • Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction failure

    CLAG Regimen improves CR rate in acute myeloid leukemia patients with first-induction failure

    6 months

Study Arms (1)

Group

Acute myeloid leukemia patients with first-induction failure

Combination Product: CLAG

Interventions

CLAGCOMBINATION_PRODUCT

Acute myeloid leukemia patients are re-induced by CLAG Regimen after first-induction failure

Group

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute myeloid leukemia patients don't achieve CR after first-induction chemotherapy.

You may qualify if:

  • Acute myeloid leukemia patients with first-induction failure

You may not qualify if:

  • Acute myeloid leukemia patients with serious infection and organ dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nanfang Hospital of Southern Medical University

Guanzhou, Guangdong, 510515, China

Location

Nanfang Hospital of Southern Medical University

Guanzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Xuejie Jiang, Doctor

    Nanfang Hospital, Southern Medical University

    STUDY CHAIR

Central Study Contacts

Xuejie Jiang, Doctor

CONTACT

+86 18688869522jxj3331233@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 25, 2023

Study Start

July 2, 2023

Primary Completion (Estimated)

August 20, 2027

Study Completion (Estimated)

December 20, 2027

Last Updated

July 5, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

CLAG Regimen is used to re-induce acute myeloid leukemia patients after first-induction failure

Locations

CN(2)