Contact information
Type
Scientific
Primary contact
Dr L F Verdonck
ORCID ID
Contact details
University Medical Centre Utrecht
Department of Haematology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 7230
l.f.verdonck@azu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Ho26
Study information
Scientific title
Acronym
HOVON 26 NHL
Study hypothesis
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, placebo controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Non Hodgkin's lymphoma (NHL)
Intervention
Patients will be randomised between:
Arm A: Three courses of standard cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every three weeks.
Arm B: Three courses of intensified CHOP every two weeks plus Granulocyte-Colony Stimulating Factor (G-CSF).
Patients with less than Partial Response (PR) will go off protocol. Patients in PR or Complete Response (CR) will proceed to another five courses of standard CHOP or another three courses of intensified CHOP plus G-CSF.
Intervention type
Drug
Phase
Phase III
Drug names
Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), and Granulocyte-Colony Stimulating Factor (G-CSF).
Primary outcome measures
CR rate and overall survival.
Secondary outcome measures
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, number of days in hospital, treatment-related mortality, duration of leucopenia and other aspects in relation to dose intensity
Overall trial start date
11/11/1994
Overall trial end date
01/04/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Previously untreated patients with a primary Non Hodgkins Lymphoma (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:
a. stage II, Lactate Dehydrogenase (LDH) greater than or equal to 1.5 x normal
b. stage III, LDH greater than 1.5 x normal
c. stage IV, LDH less than 1.5 x normal
3. Age greater than or equal to 15, or less than or equal to 65 years
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
513
Participant exclusion criteria
1. Patients with prior malignancies, except stage one cervix carcinoma and basocellular carcinoma
2. Patients with severe cardiac (means severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%) pulmonary, neurologic or metabolic disease.
3. Inadequate liver or renal function i.e. serum creatinine or bilirubin greater than 25 x the upper normal value, except when related to the lymphoma
4. Human Immunodeficiency Virus (HIV) positivity
5. Inability to give informed consent
6. Involvement of the central nervous system by the NHL
Recruitment start date
11/11/1994
Recruitment end date
01/04/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
Daniel den Hoed Kliniek (Erasmus Medical Centre) (The Netherlands)
Sponsor details
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 439 1568
hdc@erasmusmc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17132720
Publication citations
-
Verdonck LF, Notenboom A, de Jong DD, MacKenzie MA, Verhoef GE, Kramer MH, Ossenkoppele GJ, Doorduijn JK, Sonneveld P, van Imhoff GW, Intensified 12-week CHOP (I-CHOP) plus G-CSF compared with standard 24-week CHOP (CHOP-21) for patients with intermediate-risk aggressive non-Hodgkin lymphoma: a phase 3 trial of the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON)., Blood, 2007, 109, 7, 2759-2766, doi: 10.1182/blood-2006-07-035709.