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Effect of recombinant G-CSF on the results of chemotherapy (CHOP) in elderly patients with intermediate-/high-grade Non-Hodgkin’s Lymphoma. A prospective phase III study.


- candidate number1520
- NTR NumberNTR320
- ISRCTNISRCTN26340837
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsHO25 
- Public TitleEffect of recombinant G-CSF on the results of chemotherapy (CHOP) in elderly patients with intermediate-/high-grade Non-Hodgkin’s Lymphoma. A prospective phase III study.
- Scientific TitleEffect of recombinant G-CSF on the results of chemotherapy (CHOP) in elderly patients with intermediate-/high-grade Non-Hodgkin’s Lymphoma. A prospective phase III study.
- ACRONYMHOVON 25 NHL
- hypothesisThe hypothesis to be tested is that the outcome in arm B is better than in arm A.
- Healt Condition(s) or Problem(s) studiedNon Hodkin's lymfoma (NHL)
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-1994
- planned closingdate5-sep-2000
- Target number of participants410
- InterventionsPatients 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.
- Primary outcomeCR rate.
- Secondary outcome1. Relapse rate;
2. Event-free survival;
3. Overall survival;
4. Treatment-related morbidity;
5. Therapy-related hospital admissions;
6. Mortality.
- TimepointsN/A
- Trial web sitehttp://www.hovon.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. P. Sonneveld
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P. Sonneveld
- Sponsor/Initiator VU University Medical Center, Dutch haemato-oncology association (Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Funding
(Source(s) of Monetary or Material Support)
Amgen, CKTO, Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Johnson & Johnson, Roche Nederland BV, Novartis Pharma B.V.
- Publications1. J.K. Doorduijn, I. Buijt, B. van der Holt, M. van Agthoven, P. Sonneveld and C.A. Uyl-de Groot. Economic evaluation of prophylactic granulocyte colony stimulating factor during chemotherapy in elderly patients with aggressive non-Hodgkin's lymphoma. Haematologica, 89(9), 1109-1117. 2004;
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.
- Brief summaryStudy 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.
- Main changes (audit trail)
- RECORD9-sep-2005 - 20-mei-2008


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