N/A
N=15
Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease
Graft vs Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT01042509 ↗Enrolled (actual)
15
Serious AEs
66.7%
Results posted
Feb 2017
Primary outcome: Primary: Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006. — 100; 78; 80 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alemtuzumab and rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006. |
100; 78; 80 | — |
| SECONDARY Side Effects |
10 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients with chronic graft-versus-host disease.
- Patients over 18 years old.
- Patients who received first-line treatment with no response (failure), relapse or steroid dependance.
Exclusion Criteria
- Patients with active bacterial or viral infections.
- Patients with hematologic disease progression.
- Patient's intolerance to drugs.
Data sourced from ClinicalTrials.gov (NCT01042509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.