Contact information
Type
Scientific
Primary contact
Dr Ellen Meijer
ORCID ID
Contact details
University Medical Center Utrecht
Department of Hematology/H03.102
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2507230
e.meijer@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
R'mabcGVHD
Study hypothesis
B cells contribute to the development of chronic Graft Versus Host Disease (cGVHD).
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Non-randomised trial
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic Graft Versus Host Disease (cGVHD)
Intervention
Treatment with Rituximab once a week, for four weeks.
Intervention type
Drug
Phase
Not Specified
Drug names
Rituximab
Primary outcome measures
Proportion of complete and partial responses:
A complete response will be defined as a complete resolution of clinical evidence of chronic GVHD.
A partial response will be defined by an improvement in any of the affected organs.
Secondary outcome measures
Proportion of patients with a histological response.
Overall trial start date
01/07/2006
Overall trial end date
01/07/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged over 18 years
2. Steroid refractory chronic GVHD, including skin localisation
3. No other treatment apart from steroids and when applicable standard GVHD prevention
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Relapse with a life expectancy of less than six months
2. Severe infections
Recruitment start date
01/07/2006
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
Funders
Funder type
Industry
Funder name
Koningin Wilhelmina Fonds (KWF) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Roche Nederland BV (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary