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

ISRCTN ISRCTN74547745
DOI https://doi.org/10.1186/ISRCTN74547745
Secondary identifying numbers HD2002 Rituximab maintenance
Submission date
13/09/2005
Registration date
08/12/2005
Last edited
27/11/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Anthony D. Ho
Scientific

INF 410
Heidelberg
69120
Germany

Phone +49 (0)6221 568001
Email sekretariat.ho@med.uni-heidelberg.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleRandomized Phase III trial: Maintenance therapy with the monoclonal chimeric antibody rituximab compared to observation in patients with CD20+ B-cell Non-Hodgkins lymphoma
Study acronymHD2002 Rituximab maintenance
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedB-cell lymphoma
InterventionRituximab maintenance compared to observation
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Rituximab
Primary outcome measureEvent-free survival
Secondary outcome measuresOverall survival, progression-free survival
Overall study start date24/06/2002
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants174
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment24/06/2002
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

INF 410
Heidelberg
69120
Germany

Sponsor information

University of Heidelberg (Germany) and Roche (Switzerland)
Industry

University of Heidelberg
Administration Office
INF 672
Heidelberg
69120
Germany

Phone +49 (0)6221 568001
Email mathias.witzens-harig@med.uni-heidelberg.de
Website http://www.uni-heidelberg.de
ROR logo "ROR" https://ror.org/038t36y30

Funders

Funder type

Industry

Roche (Switzerland)
Government organisation / For-profit companies (industry)
Alternative name(s)
F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG, Roche Holding AG, Roche Holding Ltd, Roche Holding, Roche Holding A.G., Roche Holding, Limited, F. Hoffmann-La Roche & Co.
Location
Switzerland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2015 Yes No

Editorial Notes

27/11/2015: Publication reference added.