Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation

Description

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.

Conditions

Allogeneic Hematopoietic Cell Transplantation

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Study Overview

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Study Details

Study overview

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.

Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation in Non-Malignant Diseases

Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation

Condition
Allogeneic Hematopoietic Cell Transplantation
Intervention / Treatment

-

Contacts and Locations

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients who are undergoing allogeneic HCT at CCHMC with an alemtuzumab-containing preparative regimen for treatment of a non-malignant disease are eligible.
  • * Age ≥ 6 weeks to ≤ 30 years (at time of enrollment).
  • * For the first 7 patients, patients must have a 10/10 HLA matched related or unrelated stem cell donor, or be receiving a CD34+ selected stem cell product. After the first 7 patients, any donor match may be allowed after data review by the BMT clinicians and the PI.
  • * Patients with a history of anaphylaxis to alemtuzumab.
  • * Patients who have previously received alemtuzumab and have not cleared alemtuzumab prior to the start of the preparative regimen.
  • * Life expectancy less than 4 weeks.
  • * Patients receiving dialysis or plasmapheresis at the time of the start of the conditioning regimen.
  • * Failure to sign informed consent and/or assent, or inability to undergo informed consent process.
  • * It is not medically advisable to obtain the specimens necessary for this study.
  • * Not able to tolerate subcutaneous dosing (patients with severe skin conditions).
  • * Patients with cancer.

Ages Eligible for Study

6 Weeks to 30 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital Medical Center, Cincinnati,

Parinda Mehta, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

2028-08-31