Humanized Anti-CD25 Antibody for Prophylaxis of aGVHD in... | NCT05923814

Studies
Humanized Anti-CD25 Antibody for Prophylaxis of aGVHD in Elderly Underwent HID-HSCT

NCT05923814

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Status

Unknown status

Last Update Posted

Jun 28, 2023Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

The Effecacy and Safety of Humanized CD25 Antibody in aGVHD Prophylaxis Among Elderly Patients After HID-HSCT

Interventions

CD25 prophylaxis

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

May 2023

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 7, 2023Estimated

Primary Completion Date

May 7, 2024Estimated

Completion Date

May 7, 2024Estimated

First Submitted Date

Jun 20, 2023

First Submission Date that Met QC Criteria

Jun 20, 2023

First Posted Date

Jun 28, 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

Jun 20, 2023

Last Update Posted Date

Jun 28, 2023Actual

Description Module

Brief Summary

Age is no longer a barrier to successful allogeneic hematopoietic cell transplantation. However, the incidence of aGVHD is still high among the elderly, especially for patients receiving HID-HSCT. We designed this clinical trial to use humanized CD25 antibody for aGVHD prophylaxis among in elderly patients aged 50 and older. The humanized CD25 antibody was administered at 1 mg/kg iv on days+1 and +4 after HSCT.

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 prophylaxis

Name	Type	Description	Arm Group Labels	Other Names
CD25 prophylaxis	Drug	The humanized CD25 antibody was administered at 1 mg/kg iv on days+1 and +4 after HSCT.	treatment arm

Measure	Description	Time Frame
the incidence of aGVHD		24 weeks after HSCT

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) hematological malignances patients underwent HLA-haploidentical donor HSCT. (2) Age elder than or equal to 50 years; (3) Informed consent may be signed by themselves. (4) HIV negative, HBV, HCV negative; (5) Informed consent must be signed before the start of the study procedures, and informed consent must be signed by the patient himself or his immediate family. 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:

(1) received a previous allogeneic HSCT; (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

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided