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 |
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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
Contact information
Prof Anthony D. Ho
Scientific
Scientific
INF 410
Heidelberg
69120
Germany
Phone | +49 (0)6221 568001 |
---|---|
sekretariat.ho@med.uni-heidelberg.de |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Study acronym | HD2002 Rituximab maintenance |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | B-cell lymphoma |
Intervention | Rituximab maintenance compared to observation |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Rituximab |
Primary outcome measure | Event-free survival |
Secondary outcome measures | Overall survival, progression-free survival |
Overall study start date | 24/06/2002 |
Completion date | 31/12/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 174 |
Key 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 |
Key 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 |
Date of first enrolment | 24/06/2002 |
Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
INF 410
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University of Heidelberg (Germany) and Roche (Switzerland)
Industry
Industry
University of Heidelberg
Administration Office
INF 672
Heidelberg
69120
Germany
Phone | +49 (0)6221 568001 |
---|---|
mathias.witzens-harig@med.uni-heidelberg.de | |
Website | http://www.uni-heidelberg.de |
https://ror.org/038t36y30 |
Funders
Funder type
Industry
Roche (Switzerland)
Government organisation / For-profit companies (industry)
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 | |
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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 |
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.