Prophylaxis of Graft-versus-host Disease With Anti-CD25 A... | NCT06334367

Studies
Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT

NCT06334367

Sponsor

Wang Xin

Status

Unknown status

Last Update Posted

Mar 28, 2024Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

GVHD

Interventions

CD25 treatment
low-dose ATG

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2024Estimated

Primary Completion Date

Mar 26, 2026Estimated

Completion Date

Mar 26, 2026Estimated

First Submitted Date

Mar 11, 2024

First Submission Date that Met QC Criteria

Mar 26, 2024

First Posted Date

Mar 28, 2024Actual

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

Mar 26, 2024

Last Update Posted Date

Mar 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. In order to explore better methods for controlling GVHD, we designed a clinical trial using CD25 monoclonal antibody for GVHD prevention. Our previous studies have shown that reduced-dose anti-thymocyte globulin(ATG) in the conditioning regimen can achieve the same effect as full-dose ATG. Here, we try to explore the preventive effect of CD25 antibody on acute and chronic GHVD under low-dose ATG pretreatment condition.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CD25 treatment	Experimental	The humanized CD25 antibody was administered at 1 mg/kg iv on days+4 and +7 after HSCT.	Drug: CD25 treatment Drug: low-dose ATG
control group	Other		Drug: low-dose ATG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CD25 treatment	Drug	CD25 prophylaxis	CD25 treatment
low-dose ATG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of aGVHD	The time of aGVHD occurrence	100 days after HSCT
The incidence of cGVHD	The time of cGVHD occurrence	1 year after HSCT

Secondary Outcomes

Measure	Description	Time Frame
the time of immune reconstitution in haploidentical transplant	the time of immune reconstitution in haploidentical transplant	2 years after HSCT
the time of infection occurrence	The incidence of infection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a clear diagnosis of hematologic disease, weighing ≥30kg, aged 18-60, of any gender and race;
Willing to undergo haploidentical hematopoietic stem cell transplantation;
Voluntarily participate in this study;
Each subject must sign an informed consent form (ICF) indicating their understanding of the purpose and procedures of the study, and their willingness to participate. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member.

Exclusion Criteria:

Those with severe organ dysfunction or diseases, such as heart, liver, kidney, and pancreatic diseases;
Patients who cannot tolerate CD25 monoclonal antibody treatment;
Subjects and/or authorized family members who refuse allo-HSCT treatment;
Any life-threatening diseases, physical conditions, or organ system dysfunctions that the researcher believes may jeopardize the safety of the subject and pose unnecessary risks to the study; drug dependence; uncontrolled mental illness in subjects; cognitive dysfunction;
Those who have participated in other similar clinical studies within the past 3 months;
Those deemed unsuitable for inclusion by the researcher (such as patients expected to be unable to adhere to treatment due to financial issues, etc.).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaosheng Fang	Contact	8615168889703	8615168889703	fxsh_1010@126.com

Overall Officials

Name	Affiliation	Role
Xin Wang	Shandong Provincial Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University		Jinan	Shandong	250021	China

IPD Sharing Statement Module

Plan to Share IPD

Description

We need to collect data during the experiment for a more comprehensive sharing.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided