The hypothesis to be tested is that the outcome in arm B is better than in arm A.
ID
Bron
Verkorte titel
Aandoening
Non Hodgkin’s Lymphoma
Ondersteuning
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
- Koningin Wilhelmina Fonds (KWF)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Event-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.
Achtergrond van het onderzoek
Study 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.
Doel van het onderzoek
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patients 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®).
Publiek
P. Sonneveld
Erasmus University Medical Center,
Department of Hematology
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033589
p.sonneveld@erasmusmc.nl
Wetenschappelijk
P. Sonneveld
Erasmus University Medical Center,
Department of Hematology
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033589
p.sonneveld@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL149 |
| NTR-old | NTR184 |
| Ander register | : Ho46 |
| ISRCTN | ISRCTN84611849 |