A Multicenter Prospective Cohort Study Study of CLAG Regi... | NCT05875649

Studies
A Multicenter Prospective Cohort Study Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure

NCT05875649

Sponsor

Nanfang Hospital, Southern Medical University

Status

Not yet recruiting

Last Update Posted

Jul 5, 2023Actual

Enrollment

137Estimated

Phase

Not provided

Conditions

Interventions

CLAG

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2023Estimated

Primary Completion Date

Aug 20, 2027Estimated

Completion Date

Dec 20, 2027Estimated

First Submitted Date

May 16, 2023

First Submission Date that Met QC Criteria

May 16, 2023

First Posted Date

May 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2023

Last Update Posted Date

Jul 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

24 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

137Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group		Acute myeloid leukemia patients with first-induction failure	Combination Product: CLAG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CLAG	Combination Product	Acute myeloid leukemia patients are re-induced by CLAG Regimen after first-induction failure	Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute myeloid leukemia patients with first-induction failure

Exclusion Criteria:

Acute myeloid leukemia patients with serious infection and organ dysfunction.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xuejie Jiang, Doctor	Contact	+86 18688869522		jxj3331233@163.com

Overall Officials

Name	Affiliation	Role
Xuejie Jiang, Doctor	Nanfang Hospital, Southern Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanfang Hospital of Southern Medical University		Guanzhou	Guangdong	510515	China
Nanfang Hospital of Southern Medical University

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided