Precision Dosing of Alemtuzumab

NCT03302754 | Completed DMC

• 1 other identifier: 2017-2206
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a pilot trial of a Precision Dosing approach to alemtuzumab dosing for allogeneic hematopoietic cell transplantation of patients with non-malignant diseases. The investigators will measure the ability to use a population PK model of alemtuzumab to target patient Day 0 alemtuzumab levels to 0.15-0.6ug/mL in a pilot study of 20 patients.

Conditions

Allogeneic Hematopoietic Cell Transplantation

Outcome Measures

Primary Outcomes (1)

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

  100 Days

Study Arms (1)

Alemtuzumab

OTHER

Patients less than 15kg will be given 0.6mg/kg alemtuzumab divided over days -14, -13, and -12 (0.2mg/kg/dose). Patients greater than 15kg will be given a 3mg "test" dose on day -14 in order to limit the first dose to no more than 3 mg per the manufacturer's recommendation. This will be followed by 0.23mg/kg/dose on days -13 and -12 (to equal a total dose of approximately 0.5-0.6mg/kg). Alemtuzumab will be drawn into a sterile syringe and given to patients subcutaneously.

Drug: Alemtuzumab

Interventions

Alemtuzumab DRUG

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. 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.

Also known as: Campath

Alemtuzumab

Eligibility Criteria

• Age: 6 Weeks - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients who are undergoing RIC HCT with alemtuzumab, fludarabine, and melphalan at CCHMC for treatment of a non-malignant disease.
• Age ≥ 6 weeks to ≤ 30 years (at time of enrollment).
• 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 PI and medical monitor.

You may not qualify 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 2 weeks.
• Patients receiving dialysis.
• 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 such as epidermolysis bullosa).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Interventions

Alemtuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rebecca Marsh, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: October 5, 2017
• Study Start: October 5, 2017
• Primary Completion: March 10, 2019
• Study Completion: March 10, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)