No registrations found.
ID
Source
Brief title
Health condition
Non Hodgkin’s Lymphoma
Sponsors and support
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)
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
1. 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.
Background summary
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.
Study objective
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Study design
N/A
Intervention
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®).
P. Sonneveld
Erasmus University Medical Center,
Department of Hematology
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033589
p.sonneveld@erasmusmc.nl
P. Sonneveld
Erasmus University Medical Center,
Department of Hematology
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033589
p.sonneveld@erasmusmc.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL149 |
| NTR-old | NTR184 |
| Other | : Ho46 |
| ISRCTN | ISRCTN84611849 |