Anti-CD20 therapy for the treatment of chronic Graft Versus Host Disease
| ISRCTN | ISRCTN43525354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43525354 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Non-randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rituximab |
| Primary outcome measure | 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 study start date | 01/07/2006 |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
Sponsor information
University Medical Center Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 85500
Utrecht
3508 GA
Netherlands
"ROR" |
https://ror.org/0575yy874 |
|---|
Funders
Funder type
Industry
Koningin Wilhelmina Fonds (KWF) (The Netherlands)
No information available
Roche Nederland BV (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
