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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.


- candidate number1418
- NTR NumberNTR239
- ISRCTNISRCTN11397785
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR6-sep-2005
- Secondary IDsHo26 
- Public TitleIntensified 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 TitleIntensified 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.
- ACRONYMHOVON 26 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 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-nov-1994
- planned closingdate1-apr-2004
- Target number of participants513
- InterventionsPatients 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. 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 outcomeCR rate and overall survival.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web sitehttp://www.hovon.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. L.F. Verdonck
- CONTACT for SCIENTIFIC QUERIESDr. 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)
- Funding
(Source(s) of Monetary or Material Support)
Koningin Wilhelmina Fonds (KWF), Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- PublicationsBlood. 2007 Apr 1;109(7):2759-66.
- Brief summaryStudy phase:
phase III.


Study objective:
evaluation of the effect of intensified CHOP q 2 weeks + G-CSF with respect to CR rate and disease-free and overall survival.


Patient population:
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)
- RECORD6-sep-2005 - 12-jun-2008


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