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
Intervention
Outcome measures
Primary outcome
CR rate.
Secondary outcome
1. Relapse rate;
2. Event-free survival;
3. Overall survival;
4. Treatment-related morbidity;
5. Therapy-related hospital admissions;
6. Mortality.
Background summary
Study phase: phase III;
Study objective:
Evaluation of the effect of G-CSF on response and survival of NHL to therapy. Evaluation of the effect of prophylactic G-CSF on treatment-related morbidity and mortality. Evaluation of possible beneficial effect of G-CSF on patient adherence to Relative Dose Intensity of the standard therapy.
Patient population:
Patients with previously untreated NHL, stage II-IV, intermediate or high grade, age >= 65 years.
Study design:
prospective, multicenter, randomized;
Duration of treatment:
Expected duration of treatment is maximally 8 months.
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 at entry between:
Arm A: CHOP q 3 weeks, 6 or 8 courses;
Arm B: CHOP q 3 weeks, 6 or 8 courses + 300 mcg s.c. daily. G-CSF
CHOP consists of cyclophosphamide, doxorubicin, vincristine and prednisone.
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. Previously untreated Non-Hodgkin’s Lymphoma;
2. Ann Arbor stage II, III or IV;
3. Intermediate- or high grade malignancy (Working Formulation), confirmed by histology;
4. Age >= 65 years;
5. Informed consent.
Exclusion criteria
1. Treatment for NHL with chemotherapy or radiotherapy (local irradiation to life-threatening tumor infiltration is allowed);
2. Lymphoblastic lymphoma;
3. Other malignant diseases, except localized squamous skin carcinoma;
4. Severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%;
5. Inadequate liver or renal function, i.e. serum creatinine or serum bilirubin > 1.5x the upper normal value, except when related to lymphoma organ infiltration;
6. HIV positivity.
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 | NL282 |
| NTR-old | NTR320 |
| Other | : HO25 |
| ISRCTN | ISRCTN26340837 |
Summary results
2. J.K. Doorduijn, B. van der Holt, G.W. van Imhoff, K.G. van der Hem, M.H.H. Kramer, M.H.J. van Oers, G.J. Ossenkoppele, M.R. Schaafsma, L.F. Verdonck, G.E.G. Verhoef, M.M.C. Steijaert, I. Buijt, C.A. Uyl-de Groot, M. van Agthoven, A.H. Mulder and P. Sonneveld for the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON). CHOP compared with CHOP plus granulocyte colony-stimulating factor in elderly patients with aggressive non-Hodgkin's lymphoma. Journal of Clinical Oncology, 21(16), 3041-3050. 2003.