Recruiting
Phase 2

Alemtuzumab

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05501756

Conditions

Allogeneic Hematopoietic Cell Transplantation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Alemtuzumab

Study Details

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.

Conditions

Allogeneic Hematopoietic Cell Transplantation

Study ID

NCT05501756

Start date

Jan 11, 2023

Status verified date

Jun, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.
  • 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.
  • Patients whose clinical condition suggest there may be inability to successfully perform the PK modeling such as, but not limited to, active flaring of hemophagocytic lymphohistiocytosis in which excessive lymphoproliferation may significantly alter the target-mediated clearance of alemtuzumab and prevent observation of non-target mediated clearance which is needed for robust modeling.
  • Patients whose pre-alemtuzumab level reveals an interfering substance which prevents accurate measurement of alemtuzumab.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Alemtuzumab

Patients will be given 10 mg/m2 alemtuzumab divided over days -14, -13, and -12. The first dose should be limited to no more than 3 mg per the manufacturer's recommendation. If the calculated daily dose is greater than 3 mg, the first dose (day -14) should be limited to 3 mg and the remainder of the dosing should be divided over days -13 and -12.

Alemtuzumab will be drawn into a sterile syringe and given to patients subcutaneously.

Interventions

Alemtuzumab

Alemtuzumab (Campath®) is a recombinant DNA-derived humanized monoclonal antibody directed against CD52. Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product. Alemtuzumab is a sterile, clear, colorless, isotonic pH 6.8-7.4 solution for injection. Alemtuzumab is supplied in single-use clear glass ampules containing 30 mg of Alemtuzumab in 3 mL of solution. A single use vial of alemtuzumab contains 30 mg alemtuzumab, 8 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate.

Primary outcome measure

  • Alemtuzumab levels [ Time Frame: 100 days ]

Central Contacts and Locations

Central contacts

Caitlin Cottrell

513-803-7039Caitlin.Cottrell@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Caitlin Cottrell

Caitlin.cottrell@cchmc.org

Principal Investigator:

Parinda Mehta, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-06-12.