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Monoclonal Antibodies

Alemtuzumab Dosing for Bone Marrow Transplant

Phase 2

Recruiting

Led By Rebecca Marsh, 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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 100 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alemtuzumab

Secondary study objectives

CD4+ T cell count

Side effects data

From 2017 Phase 4 trial • 8 Patients • NCT01395316

13%

Hypothyroidism

100%

80%

60%

40%

20%

Study treatment Arm

Alemtuzumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1880

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