Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Alemtuzumab
DrugAlemtuzumab (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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: AlemtuzumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Alemtuzumab levels
Number of patients who have alemtuzumab levels in the optimal therapeutic range on Day 0.
Time frame
100 daysSecondary outcomes
1
CD4+ T cell count
CD4+ T cell count in patients who achieve the target window compared to patients who do not.
Time frame
100 daysSponsors and contacts
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Source ClinicalTrials.gov