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

NCT ID: NCT05923814

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-07
• Study Completion Date: 2024-05-07

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment arm

Group Type: EXPERIMENTAL

CD25 prophylaxis

Intervention Type: DRUG

The humanized CD25 antibody was administered at 1 mg/kg iv on days+1 and +4 after HSCT.

Interventions

CD25 prophylaxis

The humanized CD25 antibody was administered at 1 mg/kg iv on days+1 and +4 after HSCT.

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IIT-CD25-01-CAMS

Identifier Type: -

Identifier Source: org_study_id