Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alemtuzumab.
- Who it may be relevant to
- Registry conditions: Allogeneic Hematopoietic Cell Transplantation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation in Non-Malignant Diseases
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.
Detailed description
Alemtuzumab levels at Day 0 can affect:
* the chances of developing acute graft versus host disease (GVHD), which is an immune reaction of the donor cells against your own tissues * the chances of developing mixed chimerism, which is having a mixture of your own cells and donor cells after HCT, and * recovery of your immune system following transplant.
High levels of alemtuzumab are associated with more mixed chimerism and slower immune recovery, while low levels are associated with more acute GVHD. The investigators have developed a plan to adjust the alemtuzumab dose for patients to target Day 0 levels to fall within an ideal effective range of 0.15-0.9 ug/mL. This range may minimize the risks of these complications. The investigators are conducting this study to determine if the current plan for alemtuzumab dosing will be successful in the majority of patients and evaluate the impact on the clinical outcomes of acute GVHD, mixed chimerism, and immune recovery.
Interventions
- Drug 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 alemtuzu
Primary outcome measures
- Alemtuzumab levels [Time frame: 100 days]
Secondary outcome measures (1)
- CD4+ T cell count [Time frame: 100 days]
Eligibility 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT05501756 · 2022-0447