Anti-CD20 therapy for the treatment of chronic Graft Versus Host Disease
| ISRCTN | ISRCTN43525354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43525354 |
| Protocol serial number | N/A |
| Sponsor | University Medical Center Utrecht (UMCU) (The Netherlands) |
| Funders | Koningin Wilhelmina Fonds (KWF) (The Netherlands), Roche Nederland BV (The Netherlands) |
- Submission date
- 12/10/2006
- Registration date
- 12/10/2006
- Last edited
- 12/10/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ellen Meijer
Scientific
Scientific
University Medical Center Utrecht
Department of Hematology/H03.102
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 2507230 |
|---|---|
| e.meijer@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised trial |
| Secondary study design | Single-centre |
| Scientific title | |
| Study acronym | R'mabcGVHD |
| Study objectives | B cells contribute to the development of chronic Graft Versus Host Disease (cGVHD). |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Chronic Graft Versus Host Disease (cGVHD) |
| Intervention | Treatment with Rituximab once a week, for four weeks. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rituximab |
| Primary outcome measure(s) |
Proportion of complete and partial responses: |
| Key secondary outcome measure(s) |
Proportion of patients with a histological response. |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key 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 |
| Key exclusion criteria | 1. Relapse with a life expectancy of less than six months 2. Severe infections |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 01/07/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
