Non Hodgkin’s Lymphoma.
Conditions
Interventions
Patients will be randomized between:
Arm A:
3 courses of standard CHOP q 3 weeks.
Arm B:
3 courses of intensified CHOP q 2 weeks plus G-CSF.
Patients with less than PR will go off protocol. Pat
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. Previously untreated patients with a primary NHL of intermediate- or high-grade malignancy according to the Working Formulation (group D,E,F,G,H); 2. Belonging to the intermediate risk group: stage II, LDH >=1.5x normal; stage III, LDH >1.5x normal; stage IV, LDH =15 <=65 years.
Exclusion criteria
Exclusion criteria: 1. Patients with prior malignancies, except stage 1 cervix carcinoma and basocellular carcinoma; 2. Patients with severe cardiac (means severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of 2.5x the upper normal value, except when related to the lymphoma; 3. HIV positivity; 4. Inability to give informed consent; 5. Involvement of the central nervous system by the NHL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR rate and overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease-free survival; 2. Relapse rate; 3. Assessment of value of risk factors at diagnosis in relation to dose intensity of the treatment; 4. Morbidity, nr of days in hospital, treatment-related mortality, duration of leucopenia and other aspects in relation to dose intensity. | — |
Contacts
Public ContactL.F. Verdonck
University Medical Center Utrecht (UMCU), Department of Hematology, P.O. Box 85500
Outcome results
None listed