Standard chemotherapy combination (Cyclophosphamide, Hydroxydaunorubicin, Vincristine, Prednisolone [CHOP]) with 1, 3 or 6 cycles of the monoclonal anti-CD20-antibody. Rituximab in first line therapy of follicular non-Hodgkins lymphoma.
| ISRCTN | ISRCTN47525145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47525145 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/09/2005
- Registration date
- 06/01/2006
- Last edited
- 24/07/2014
- 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 Ho
Scientific
Scientific
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
| Phone | +49 (0)6221 568001 |
|---|---|
| sekretariat_ho@med.uni-heidelberg.de |
Study information
| Study design | Randomised Controlled Trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HD2000 |
| Study objectives | Six infusions of Rituximab, added to 6 cycles of standard chemotherapy (CHOP), are more effective than 1 or 3 infusions of Rituximab in the production of a molecular remission, as determined by t(14;18) real time Polymerase Chain Reaction (PCR) in peripheral blood and bone marrow. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Follicular Lymphoma World Health Organisation (WHO) Grade I and II, Stage 3-4 |
| Intervention | 6 x CHOP + 1 x Rituximab versus 6 x CHOP + 3 x Rituximab versus 6 x CHOP + 6 x Rituximab |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | CHOP and Rituximab |
| Primary outcome measure | Molecular remission rate after the end of six cycles of CHOP with various cycles of Rituximab antibodies, determined by t(14;18) real time PCR in peripheral blood and bone marrow. |
| Secondary outcome measures | 1. Clinical remission rate 2. Duration of molecular and clinical response 3. Toxicity |
| Overall study start date | 01/09/2000 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Patients with histologically proven CD20+ follicular lymphoma (follicular lymphoma grade I, II), stage III and IV 2. Age >18 years, no upper limit 3. No pre-treatment except irradiation and/or corticosteroids 4. Requirement of therapy: one or more of the following: B-symptoms, hematopoietic insufficiency (leukopenia <1.5/nl, anemia hb <10 g/dl, platelets <100/nl) 5. Objective tumor progression (>50% increase in sum of tumor diameters in six months); 'bulky disease' (mediastinal/abdominal tumor >7.5 cm and/or other lymphnodes >5 cm) |
| Key exclusion criteria | 1. Age <18 years 2. Stage I or II 3. CD20 negativity 4. Karnofsky Index <80% or Eastern Cooperative Oncology Group (ECOG) >2 5. Pre-treatment with murine antibodies, severe organ impairment (heart, lung, neck) according to common criteria 6. Pre-treatment with any chemotherapy |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University of Heidelberg (Germany)
University/education
University/education
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
| Phone | +49 (0)6221 568001 |
|---|---|
| sekretariat_ho@med.uni-heidelberg.de | |
| Website | http://www.klinikum.uni-heidelberg.de/index.php?id=725 |
"ROR" |
https://ror.org/038t36y30 |
Funders
Funder type
Industry
Sponsored and funded by Roche and University of Heidelberg
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2012 | Yes | No |
