Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657391
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Evaluation of Recombinant Humanized Anti-CD25 Monoclonal Antibody for Preventing Graft-versus-host Disease After Haploidenticalmatched Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients with Transfusion-dependent Thalassemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Clinical Efficacy and Safety of Recombinant Humanized Anti-CD25 Monoclonal Antibody in Preventing Graft-versus-host Disease After Haploidentical Matched Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients with Transfusion-dependent Thalassemia a Prospective Multicenter Open-label Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Graft-versus-host disease GVHD is a major factor affecting the efficacy and quality of life of alternative donor transplantation in thalassemia major TM severely limiting the clinical application of alternative donor transplantation in TMThe purpose of this clinical trial is to evaluate whether recombinant humanized anti-CD25 monoclonal antibody is effective in preventing GVHD and its safety after haploidenticalmatched unrelated donor hematopoietic stem cell transplantation The main questions it aims to answer are
Does recombinant humanized anti-CD25 monoclonal antibody reduce the incidence of GVHD disease after haploidenticalmatched unrelated donor hematopoietic stem cell transplantation
What medical problems will participants experience when using the recombinant humanized anti-CD25 monoclonal antibody What is the quality of life after 2 years follow-up In this clinical trail participants will be randomly assigned to the intervention group or the control group by researchers in a 21 ratio The intervention group will be given recombinant humanized anti-CD25 monoclonal antibody 1mgKg combined with the standard GVHD prophylaxis after transplantation while the control group will only receive the standard GVHD prophylaxis The incidence of GVHD after transplantation in the two groups will be observed The main evaluation is the clinical efficacy of recombinant humanized anti-CD25 monoclonal antibody in preventing aGVHD
Does recombinant humanized anti-CD25 monoclonal antibody reduce the incidence of GVHD disease after haploidenticalmatched unrelated donor hematopoietic stem cell transplantation
What medical problems will participants experience when using the recombinant humanized anti-CD25 monoclonal antibody What is the quality of life after 2 years follow-up In this clinical trail participants will be randomly assigned to the intervention group or the control group by researchers in a 21 ratio The intervention group will be given recombinant humanized anti-CD25 monoclonal antibody 1mgKg combined with the standard GVHD prophylaxis after transplantation while the control group will only receive the standard GVHD prophylaxis The incidence of GVHD after transplantation in the two groups will be observed The main evaluation is the clinical efficacy of recombinant humanized anti-CD25 monoclonal antibody in preventing aGVHD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None