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New treatment option for Allogeneic Hematopoietic Cell Transplantation
Official title Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation
ClinicalTrials.gov ID: NCT05501756
What this study is testing
What is Alemtuzumab?
Alemtuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for allogeneic hematopoietic cell transplantation.
Also referred to as Campath.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Patients who are undergoing allogeneic HCT at CCHMC with an alemtuzumab-containing preparative regimen for treatment of a non-malignant disease are...
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- Patients whose pre-alemtuzumab level reveals an interfering substance which prevents accurate measurement of alemtuzumab.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.