|- candidate number||1418|
|- NTR Number||NTR239|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||6-sep-2005|
|- Secondary IDs||Ho26 |
|- Public Title||Intensified CHOP of 12-weeks duration plus G-CSF as compared with standard CHOP of 24-weeks duration for patients with intermediate-prognosis Non Hodgkin’s Lymphoma.|
|- Scientific Title||Intensified CHOP of 12-weeks duration plus G-CSF as compared with standard CHOP of 24-weeks duration for patients with intermediate-prognosis Non Hodgkin’s Lymphoma.|
|- ACRONYM||HOVON 26 NHL|
|- hypothesis||The hypothesis to be tested is that the outcome in arm B is better than in arm A.|
|- Healt Condition(s) or Problem(s) studied||Non Hodkin's lymfoma (NHL)|
|- 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 <1.5x normal;
3. Age >=15 <=65 years.
|- 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 < 45%) pulmonary, neurologic or metabolic disease- Inadequate liver or renal function, i.e. serum creatinine or bilirubin > 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||11-nov-1994|
|- planned closingdate||1-apr-2004|
|- Target number of participants||513|
|- Interventions||Patients will be randomized between:|
3 courses of standard CHOP q 3 weeks.
3 courses of intensified CHOP q 2 weeks plus G-CSF.
Patients with less than PR will go off protocol. Patients in PR or CR will proceed to another 5 courses of standard CHOP or another 3 courses of intensified CHOP plus G-CSF.
|- Primary outcome||CR rate and overall survival.|
|- Secondary outcome||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.
|- Trial web site||http://www.hovon.nl|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. L.F. Verdonck|
|- CONTACT for SCIENTIFIC QUERIES||Dr. L.F. Verdonck|
|- Sponsor/Initiator ||Erasmus Medical Center, Daniel den Hoed Cancer Center , VU University Medical Center, Dutch haemato-oncology association (Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)|
(Source(s) of Monetary or Material Support)
|Koningin Wilhelmina Fonds (KWF), Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)|
|- Publications||Blood. 2007 Apr 1;109(7):2759-66.
|- Brief summary||Study phase: |
evaluation of the effect of intensified CHOP q 2 weeks + G-CSF with respect to CR rate and disease-free and overall survival.
patients with primary NHL (groups D,E,F,G,H), intermediate risk, age 15-65 years inclusive.
Study design: prospective, multicenter, randomized.
Duration of treatment:
expected duration of treatment is 24 weeks for arm A and 12 weeks for arm B.
|- Main changes (audit trail)|
|- RECORD||6-sep-2005 - 12-jun-2008|