Clinical trial NCT06473909: Combination of Steroid and Humanized CD25 Monoclonal Antibody as First-line Therapy for aGVHD
Official title: An Exploratory Clinical Study on the Efficacy and Safety of Humanized CD25 Monoclonal Antibody Combined With Glucocorticoid in the First-line Treatment of Acute Graft-versus-host Disease (aGVHD) After Allo-HSCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Acute Graft Versus Host Disease
Keywords: aGVHD
humanized CD25 monoclonal antibody
glucocorticoid
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The remission rate of aGVHD
timeFrame: 28 days
Secondary outcomes:
measure: Incidence rate of severe aGVHD
timeFrame: 24 weeks
measure: overall survival
timeFrame: 24 weeks
measure: infection rate
timeFrame: 24 weeks
measure: relapse rate
timeFrame: 24 weeks
measure: non-relapse mortality
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
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