Condition category
Cancer
Date applied
13/09/2005
Date assigned
08/12/2005
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.klinikum.uni-heidelberg.de

Contact information

Type

Scientific

Primary contact

Prof Anthony D. Ho

ORCID ID

Contact details

INF 410
Heidelberg
69120
Germany
+49 (0)6221 568001
sekretariat.ho@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HD2002 Rituximab maintenance

Study information

Scientific title

Randomized Phase III trial: Maintenance therapy with the monoclonal chimeric antibody rituximab compared to observation in patients with CD20+ B-cell Non-Hodgkins lymphoma

Acronym

HD2002 Rituximab maintenance

Study hypothesis

The objective of this trial is to examine whether event free survival, overall survival and cure rate of patients with CD20+ B-cell Non-Hodgkins lymphoma can be improved by a maintenance therapy of 8 cycles rituximab q 3 months (total 24 months). The hypothesis is that residual tumor cells can be destroyed in vivo by the rituximab maintenance therapy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

B-cell lymphoma

Intervention

Rituximab maintenance compared to observation

Intervention type

Drug

Phase

Phase III

Drug names

Rituximab

Primary outcome measures

Event-free survival

Secondary outcome measures

Overall survival, progression-free survival

Overall trial start date

24/06/2002

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. B-cell CD20+ Non-Hodgkins Lymphoma (primary therapy and relapse). At study entry patients with agressive lymphoma need to have a complete remission, if a residual tumor is still present a positron-emission-tomography examination needs to reveal no active tumor. Patients with indolent lymphoma need at least a partial remission to enter this trial
2. Age above 18 years
3. Karnofsky Index above 60
4. Contraception and negative pregnancy test of women in reproducitve age
5. Valid patient approval

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

174

Participant exclusion criteria

1. Manifest cardiac insufficiency
2. Chronic obstructive lung disease with hypoximia
3. Uncontrolled hypertension
4. Renal insufficiency (creatinine above 2 mg/dl)
5. Hepatic insufficiency (Bilirubin above 2.0 mg/dl)
6. Pregnancy
7. Breast feeding
8. Severe psychiatric illness
9. Human immunodeficiency virus (HIV) positive patients
10. Primary cerebral lymphoma
11. Previous allogeneic transplant

Recruitment start date

24/06/2002

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Germany

Trial participating centre

INF 410
Heidelberg
69120
Germany

Sponsor information

Organisation

University of Heidelberg (Germany) and Roche (Switzerland)

Sponsor details

University of Heidelberg
Administration Office
INF 672
Heidelberg
69120
Germany
+49 (0)6221 568001
mathias.witzens-harig@med.uni-heidelberg.de

Sponsor type

Industry

Website

http://www.uni-heidelberg.de

Funders

Funder type

Industry

Funder name

Roche (Switzerland)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

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

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26449739

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.