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

The Administration of Humanized Anti-CD25 Antibody for Prophylaxis of aGVHD in Patients Older Than 50y Underwent HID-HSCT

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.

Study Overview

• Status: Not yet recruiting
• Conditions: The Effecacy and Safety of Humanized CD25 Antibody in aGVHD Prophylaxis Among Elderly Patients After HID-HSCT
• Intervention / Treatment: Drug: CD25 prophylaxis

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment arm	Drug: CD25 prophylaxis; The humanized CD25 antibody was administered at 1 mg/kg iv on days+1 and +4 after HSCT.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 7, 2023
• Primary Completion (Estimated): May 7, 2024
• Study Completion (Estimated): May 7, 2024

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IIT-CD25-01-CAMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No