Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation

• Status: Not yet recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

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 0.2-0.6 ug/mL.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Alemtuzumab

Criteria

Inclusion 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.

Exclusion Criteria:

• 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.