Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-03-10 @ 7:22 PM
Study NCT ID:
NCT05501756
Status:
RECRUITING
Last Update Posted:
2025-07-17
First Post:
2022-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation
Sponsor:
Children's Hospital Medical Center, Cincinnati
Organization:
Study Overview
Official Title:
Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation in Non-Malignant Diseases
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alemtuzumab is an antibody that reduces the strength of the immune system that is given in preparation for allogeneic hematopoietic cell transplant (HCT). In this research study the investigators want to find out if they can adjust the dose of alemtuzumab used as part of allogeneic HCT to target the level of Day 0 (the planned day of graft infusion) to an optimal therapeutic window of 0.15-0.9 ug/mL.
Detailed Description:
Alemtuzumab levels at Day 0 can affect:
* the chances of developing acute graft versus host disease (GVHD), which is an immune reaction of the donor cells against your own tissues
* the chances of developing mixed chimerism, which is having a mixture of your own cells and donor cells after HCT, and
* recovery of your immune system following transplant.
High levels of alemtuzumab are associated with more mixed chimerism and slower immune recovery, while low levels are associated with more acute GVHD. The investigators have developed a plan to adjust the alemtuzumab dose for patients to target Day 0 levels to fall within an ideal effective range of 0.15-0.9 ug/mL. This range may minimize the risks of these complications. The investigators are conducting this study to determine if the current plan for alemtuzumab dosing will be successful in the majority of patients and evaluate the impact on the clinical outcomes of acute GVHD, mixed chimerism, and immune recovery.
* the chances of developing acute graft versus host disease (GVHD), which is an immune reaction of the donor cells against your own tissues
* the chances of developing mixed chimerism, which is having a mixture of your own cells and donor cells after HCT, and
* recovery of your immune system following transplant.
High levels of alemtuzumab are associated with more mixed chimerism and slower immune recovery, while low levels are associated with more acute GVHD. The investigators have developed a plan to adjust the alemtuzumab dose for patients to target Day 0 levels to fall within an ideal effective range of 0.15-0.9 ug/mL. This range may minimize the risks of these complications. The investigators are conducting this study to determine if the current plan for alemtuzumab dosing will be successful in the majority of patients and evaluate the impact on the clinical outcomes of acute GVHD, mixed chimerism, and immune recovery.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: