RECRUITING

Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation

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Conditions

Allogeneic Hematopoietic Cell Transplantation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation in Non-Malignant Diseases

Quick Facts

Study Start:2023-01-11
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05501756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Weeks to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients who are undergoing allogeneic HCT at CCHMC with an alemtuzumab-containing preparative regimen for treatment of a non-malignant disease are eligible.
  2. * Age ≥ 6 weeks to ≤ 30 years (at time of enrollment).
  3. * 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.
  1. * Patients with a history of anaphylaxis to alemtuzumab.
  2. * Patients who have previously received alemtuzumab and have not cleared alemtuzumab prior to the start of the preparative regimen.
  3. * Life expectancy less than 4 weeks.
  4. * Patients receiving dialysis or plasmapheresis at the time of the start of the conditioning regimen.
  5. * Failure to sign informed consent and/or assent, or inability to undergo informed consent process.
  6. * It is not medically advisable to obtain the specimens necessary for this study.
  7. * Not able to tolerate subcutaneous dosing (patients with severe skin conditions).
  8. * Patients with cancer.

Contacts and Locations

Study Contact

Caitlin Cottrell
CONTACT
513-803-7039
Caitlin.Cottrell@cchmc.org
Evelyn Nguyen
CONTACT
513-636-4379
Evelyn.Nguyen@cchmc.org

Principal Investigator

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

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-11
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2023-01-11
Study Completion Date2028-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Allogeneic Hematopoietic Cell Transplantation