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Monoclonal Antibodies

Alemtuzumab Dosing for Bone Marrow Transplant

Phase 2
Recruiting
Led By Parinda Mehta, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days
Awards & highlights

Study Summary

This trial aims to determine the ideal dose of alemtuzumab to reduce the immune system for an allogeneic stem cell transplant.

Who is the study for?
This trial is for patients aged 6 weeks to 30 years who need a bone marrow transplant due to non-malignant diseases and are getting an alemtuzumab-based treatment. Initially, only those with a perfect donor match or receiving selected stem cells can join. After review, others may be eligible. Exclusions include life expectancy under 4 weeks, previous alemtuzumab use without clearance, dialysis or plasmapheresis at the start of treatment, cancer diagnosis, severe skin conditions preventing subcutaneous dosing, and history of allergy to alemtuzumab.Check my eligibility
What is being tested?
The study tests if adjusting the dose of Alemtuzumab can achieve optimal levels in the blood on Day 0 (day of graft infusion) for better outcomes in allogeneic hematopoietic cell transplantation (HCT). The goal is to maintain drug levels between 0.2-0.6 ug/mL.See study design
What are the potential side effects?
Alemtuzumab may weaken the immune system significantly which could increase infection risk; it might also cause allergic reactions including anaphylaxis in some individuals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alemtuzumab
Secondary outcome measures
CD4+ T cell count

Side effects data

From 2017 Phase 4 trial • 8 Patients • NCT01395316
13%
Hypothyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alemtuzumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: AlemtuzumabExperimental Treatment1 Intervention
Patients will be given 10 mg/m2 alemtuzumab divided over days -14, -13, and -12. The first dose should be limited to no more than 3 mg per the manufacturer's recommendation. If the calculated daily dose is greater than 3 mg, the first dose (day -14) should be limited to 3 mg and the remainder of the dosing should be divided over days -13 and -12. Alemtuzumab will be drawn into a sterile syringe and given to patients subcutaneously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alemtuzumab
2004
Completed Phase 4
~1890

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,531 Total Patients Enrolled
Parinda Mehta, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
5 Previous Clinical Trials
158 Total Patients Enrolled
Rebecca Marsh, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
2 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Alemtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05501756 — Phase 2
Bone Marrow Transplant Research Study Groups: Alemtuzumab
Bone Marrow Transplant Clinical Trial 2023: Alemtuzumab Highlights & Side Effects. Trial Name: NCT05501756 — Phase 2
Alemtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05501756 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For this trial, which demographic is desired to participate?

"This clinical trial seeks to enrol 60 individuals between 6 weeks and 30 years of age that have had the hematocrit procedure done. To be considered, applicants must meet certain criteria; they should have received an alemtuzumab-containing preparative regimen at CCHMC for treatment related to non-malignancy ailment, possess a 10/10 HLA matched donor (for first 7 patients) or CD34+ selected stem cell product, and match other requirements as determined by BMT clinicians and the PI after data review."

Answered by AI

Has Alemtuzumab been sanctioned by the Federal Drug Administration?

"Alemtuzumab has been assigned a safety rating of 2 due to it being in phase two trials. While there is some documentation that supports its security, there are yet no conclusive findings proving the medication's efficacy."

Answered by AI

What is the uppermost limit on participant numbers for this medical experiment?

"Affirmative. The clinicaltrials.gov registry verifies that this medical experiment, which started being advertised on November 1st 2022, is actively enrolling participants. Sixty individuals are required to be enrolled from a single medical centre."

Answered by AI

Is this clinical research accessible to individuals currently seeking participation?

"Affirmative. The information hosted on clinicaltrials.gov verifies that the trial, which was originally disseminated to the public on November 1st 2022, is presently looking for recruits. Approximately sixty individuals need to be enrolled from a single medical centre."

Answered by AI

Is this clinical trial accommodating individuals beyond sixty years of age?

"This medical study is open to individuals between 6 Weeks and 30 years of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation
2023. "Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05501756.
~40 spots leftby Aug 2028
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