Combination of Steroid and Humanized CD25 Monoclonal Anti... | NCT06473909

Studies
Combination of Steroid and Humanized CD25 Monoclonal Antibody as First-line Therapy for aGVHD

NCT06473909

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Status

Unknown status

Last Update Posted

Jun 25, 2024Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

Acute Graft Versus Host Disease

Interventions

CD25 antibody combined glucocorticoid as first-line treatment

Countries

Not provided

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

Jun 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

Jul 1, 2024Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jun 19, 2024

First Submission Date that Met QC Criteria

Jun 24, 2024

First Posted Date

Jun 25, 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

Jun 24, 2024

Last Update Posted Date

Jun 25, 2024Actual

Description Module

Brief Summary

The first-line treatment of acute graft-versus-host disease with humanized CD25 monoclonal antibody combined with glucocorticoid was used to study the remission rate of acute graft-versus-host disease, the cumulative incidence and remission rate of severe acute graft-versus-host disease, GVHD-free survival rate, all-cause mortality and quality of life evaluation, and safety evaluation for prevention programs.

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

20Estimated

Label	Type	Description	Intervention Names
treatment arm	Experimental		Drug: CD25 antibody combined glucocorticoid as first-line treatment

Name	Type	Description	Arm Group Labels	Other Names
CD25 antibody combined glucocorticoid as first-line treatment	Drug	CD25 antibody combined glucocorticoid as first-line treatment	treatment arm

Measure	Description	Time Frame
The remission rate of aGVHD		28 days

Measure	Description	Time Frame
Incidence rate of severe aGVHD		24 weeks
overall survival		24 weeks
infection rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

( 1 ) Diagnosis of grade II to IV acute graft-versus-host disease after hematopoietic stem cell transplantation.

( 2 ) older than or equal to 18 years old. ( 3 ) Informed consent can be signed by themselves. ( 4 ) HIV negative, HBV, HCV negative. ( 5 ) Informed consent must be signed before the start of the study procedure. The informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent will be signed by the legal guardian or the patient 's immediate family.

Exclusion Criteria:

• (1) diagnosed as VOD/SOS.
- (2) Uncontrolled infection at enrollment; requires mechanical ventilation or is hemodynamically unstable at the time of enrollment;
- (3) has severe hepatic insufficiency (defined as Child-Pugh Class C; has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 xthe upper limit of normal (ULN) or serum total bilirubin > 2.5 x ULN.
- (4) has end-stage renal impairment with a creatinine clearance less than 10 mL/min.
- (5) has both moderate hepatic insufficiency AND moderate renal insufficiency;
- (6) has documented positive results for human immunodeficiency virus antibody (HIVAb), hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollments;
- (7) has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas).
- (8) Suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring;
- (9) unable or unwilling to sign the consent form;
- (10) patients with other special conditions assessed as unqualified by the investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided