Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Study ID
NCT01042509
Status
Completed

Conditions

  • Graft vs Host Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Alemtuzumab and rituximab — DRUG
    Alemtuzumab at 10mg subcutaneously daily for 3 doses (days 1, 2 and 3) Rituximab at 100mg intravenously weekly for 4 doses (days 4, 11, 18 and 25

Study Details

The purpose of this study is to determine whether low-doses alemtuzumab and rituximab combination are effective in the treatment of chronic graft-versus-host disease (GVHD) after first-line therapy failure.

Key Dates

Start date
Oct 31, 2009
Status verified
Dec 2016
Primary completion
Oct 31, 2011
Completion
Jan 31, 2012

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Alemtuzumab and rituximab
    Patients with chronic GVHD after first-line therapy failure will receive Alemtuzumab at 10mg subcutaneously daily for 3 doses (days 1, 2 and 3) Rituximab at 100mg intravenously weekly for 4 doses (days 4, 11, 18 and 25. THE STUDY HAVE ONLY ONE ARM.

Primary Outcome Measure

Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006. [ Time Frame: 30, 90 and 365 days ]

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