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A randomized phase III study of chimeric anti-CD20 monoclonal antibody (Rituximab) with 2-weekly CHOP chemotherapy (CHOP 14) in elderly patients with intermediate- or high-risk non-Hodgkin’s lymphoma.


- candidate number1348
- NTR NumberNTR184
- ISRCTNISRCTN84611849
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR5-sep-2005
- Secondary IDsHo46 
- Public TitleA randomized phase III study of chimeric anti-CD20 monoclonal antibody (Rituximab) with 2-weekly CHOP chemotherapy (CHOP 14) in elderly patients with intermediate- or high-risk non-Hodgkin’s lymphoma.
- Scientific TitleA randomized phase III study of chimeric anti-CD20 monoclonal antibody (Rituximab) with 2-weekly CHOP chemotherapy (CHOP 14) in elderly patients with intermediate- or high-risk non-Hodgkin’s lymphoma.
- ACRONYMHOVON 46 NHL
- hypothesisThe hypothesis to be tested is that the outcome in arm B is better than in arm A.
- Healt Condition(s) or Problem(s) studiedNon Hodkin's lymfoma (NHL)
- Inclusion criteria1. Patients with a confirmed histologic diagnosis of NHL according to the WHO classification: Mantle cell lymphoma (MCL), Follicular lymphoma (grade III) (FL III) or Diffuse large B-cell lymphoma (DLBCL);
2. Low-intermediate, high-intermediate or high risk NHL according to age-adjusted IPI score;
3. NHL must be CD20 positive;
4. Age 65 years or more;
5. WHO performance status 0-2;
6. Written informed consent.
- Exclusion criteria1. Intolerance of exogenous protein administration;
2. Severe cardiac dysfunction (NYHA classification II-IV) or LVEF < 45 %;
3. Significant renal dysfunction (serum creatinine >= 150 mmol/l), unless related to NHL;
4. Significant hepatic dysfunction (total bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), unless related to NHL;
5. Suspected or documented Central Nervous System involvement by NHL;
6. Patients known to be HIV-positive;
7. Patients with active, uncontrolled infections;
8. Patients with uncontrolled asthma or allergy, requiring steroid treatment
ior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localized lymphoma mass or infiltration
story of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 28-nov-2001
- planned closingdate1-okt-2006
- Target number of participants400
- InterventionsPatients will be randomized between:
Arm A:
8 cycles of CHOP q 2 weeks plus G-CSF (pegfilgrastim, Neulasta®) once per cycle;
Arm B:
8 cycles of CHOP q 2 weeks plus G-CSF (pegfilgrastim, Neulasta®) once per cycle combined with 6 administrations of Rituximab (Mabthera®).
- Primary outcomeEvent-free survival (i.e. time from registration to induction failure (i.e. no CR or CRu on induction treatment), death or relapse whichever occurs first); the time to failure of patients with induction failure is set at one day.
- Secondary outcome1. Complete response;
2. Overall survival measured form the time of registration;
3. Disease-free interval (duration of the first CR) measured from the time of achievement of CR to day of relapse or death from any cause (whichever occurs first);
4. Toxicity.
- TimepointsN/A
- Trial web sitehttp://www.hovon.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. P. Sonneveld
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P. Sonneveld
- Sponsor/Initiator VU University Medical Center, Dutch haemato-oncology association (Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- PublicationsN/A
- Brief summaryStudy phase: phase III
Study objective: evaluation of the effect of anti-CD20 (Rituximab) combined with 2-weekly CHOP + G-CSF in comparison to 2-weekly CHOP + G-CSF alone
Patient population: patients with intermediate- or high-risk NHL (MCL, Follicular Lymphoma grade III or DLBCL), CD20-positive, previously untreated, age >= 65 years and good WHO performance status (WHO 0-2)
Study design: prospective, multicenter, randomized
Duration of treatment: expected duration of treatment is 16 weeks.
- Main changes (audit trail)
- RECORD1-sep-2005 - 2-sep-2009


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