CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
Alemtuzumab (Campath)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00495755
NCT00495755Phase 1Completed
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An Open Label Phase I Trial of Alemtuzumab (Campath 1-H) Therapy for Refractory Chronic Graft-vs-Host Disease

Dana-Farber Cancer Institute·interventional·Posted Jul 3, 2007·Updated Aug 9, 2013

In Brief

A Phase 1 clinical trial evaluating Alemtuzumab (Campath) for Chronic Graft-vs.-Host Disease. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The CD52 antigen, which is targeted by alemtuzumab, is highly expressed on mature T lymphocytes, monocytes and monocyte-derived dendritic cells as well as on mature B cells. Due to its more promiscuous effect on immune cells, alemtuzumab not only targets antibody producing B lymphocytes as does rituximab, but also targets alloreactive T lymphocytes and dendritic cells that also contribute to the complex pathogenesis of chronic GVHD. Our hypothesis is that alemtuzumab will be effective in the treatment of chronic GVHD through its promiscuous depletion of alloreactive T lymphocytes, dendritic cells as well as antibody producing mature B-lymphocytes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Graft-vs.-Host Disease
CountriesUnited States
CollaboratorsGenzyme, a Sanofi Company, Bayer

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 3, 2007
Enrollment StartJul 1, 2007
Primary CompletionOct 1, 2011
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.0 years ago

Interventions

Alemtuzumab (Campath)drug

An escalating dose given over 4 weeks