Condition category
Injury, Occupational Diseases, Poisoning
Date applied
12/10/2006
Date assigned
12/10/2006
Last edited
12/10/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University Medical Center Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes