Alemtuzumab for Allogeneic Bone Marrow Transplant

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Allogeneic Bone Marrow TransplantAlemtuzumab - Drug
Eligibility
6 - 30
All Sexes
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Study Summary

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 0.2-0.6 ug/mL.

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 100 days

100 days
Alemtuzumab
CD4+ T cell count

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Alemtuzumab
13%Hypothyroidism
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT01395316) in the Alemtuzumab ARM group. Side effects include: Hypothyroidism with 13%.

Trial Design

1 Treatment Group

Alemtuzumab
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Alemtuzumab · No Placebo Group · Phase 2

Alemtuzumab
Drug
Experimental Group · 1 Intervention: Alemtuzumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alemtuzumab
2004
Completed Phase 4
~1980

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 100 days

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
756 Previous Clinical Trials
5,421,191 Total Patients Enrolled
Rebecca Marsh, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
2 Previous Clinical Trials
35 Total Patients Enrolled

Eligibility Criteria

Age 6 - 30 · All Participants · 3 Total Inclusion Criteria

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