Non Hodgkin’s Lymphoma
Conditions
Interventions
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®).
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
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
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Intolerance of exogenous protein administration; 2. Severe cardiac dysfunction (NYHA classification II-IV) or LVEF = 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactP. Sonneveld
P.O. Box 2040
Outcome results
None listed