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Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation

This study is looking at how to best use a medicine called alemtuzumab (Campath®) during an allogeneic hematopoietic cell transplant (HCT). Alemtuzumab is an antibody that helps reduce the strength of your immune system before the transplant. Researchers want to find the perfect dose of alemtuzumab to reach a specific level in your body by Day 0 (the day of your transplant). This ideal level may help reduce problems like acute graft versus host disease (when donor cells attack your body) and mixed chimerism (having a mix of your own and donor cells). The study aims to see if their new dosing plan works for most patients and how it affects these outcomes and your immune system recovery. You may be able to join if you are having an allogeneic HCT at CCHMC for a non-cancerous disease and your treatment plan includes alemtuzumab. The study plans to enroll 60 participants, but its current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 60 participants. It is designed to test a new way of dosing alemtuzumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Alemtuzumab levels will be measured at 100 days after transplant.

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NCT05501756

Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation

Recruiting
PHASE2All AgesInterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~60 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Alemtuzumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Alemtuzumab levels
Measured over 100 days

Conditions

Allogeneic Hematopoietic Cell Transplantation

Explore related trials

Non-malignant diseaseHLA Complex

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

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

Who to contact

Caitlin Cottrell
[email protected]
513-803-7039
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Alemtuzumab levels100 days

    Number of patients who have alemtuzumab levels in the optimal therapeutic range on Day 0.