A randomised phase III study of chimeric anti-CD20 monoclonal antibody (rituximab) with two-weekly CHOP chemotherapy (CHOP 14) in elderly patients with intermediate or high-risk non-Hodgkins lymphoma

ISRCTN	ISRCTN84611849
DOI	https://doi.org/10.1186/ISRCTN84611849
Secondary identifying numbers	Ho46; NL149 (NTR184)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 20/08/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof P Sonneveld
Scientific

Erasmus University Medical Centre
Department of Haematology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 463 3589
Email	p.sonneveld@erasmusmc.nl

Study information

Study design	Randomised, active controlled, parallel group, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised phase III study of chimeric anti-CD20 monoclonal antibody (rituximab) with two-weekly CHOP chemotherapy (CHOP 14) in elderly patients with intermediate or high-risk non-Hodgkins lymphoma
Study acronym	HOVON 46 NHL
Study objectives	An evaluation of the effect of anti-CD20 (rituximab) combined with two-weekly cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) and Granulocyte Colony Stimulating Factor (G-CSF) in comparison to two-weekly CHOP and G-CSF alone.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Non Hodgkin's Lymphoma (NHL)
Intervention	Patients will be randomised between: Arm A: Eight cycles of CHOP every two weeks plus G-CSF (pegfilgrastim, Neulasta®) once per cycle Arm B: Eight cycles of CHOP every two weeks plus G-CSF (pegfilgrastim, Neulasta®) once per cycle combined with six administrations of Rituximab (Mabthera®)
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone and granulocyte colony stimulating factor.
Primary outcome measure	1. Event-free survival (i.e. time from registration to induction failure (i.e. no Complete Response [CR] or Complete Response uncertain [CRu] on induction treatment), death or relapse whichever occurs first) 2. The time to failure of patients with induction failure is set at one day
Secondary outcome measures	1. Complete response 2. Overall survival measured form the time of registration 3. Disease-free interval (duration of the first CR) measured from the time of achievement of CR to day of relapse or death from any cause (whichever occurs first) 4. Toxicity
Overall study start date	28/11/2001
Completion date	01/10/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	400
Key inclusion criteria	1. Patients with a confirmed histologic diagnosis of Non-Hodgkins Lymphoma (NHL) according to the World Health Organisation (WHO) classification: a. Mantle Cell Lymphoma (MCL) b. Follicular Lymphoma (grade III) (FL III) c. Diffuse Large B-Cell Lymphoma (DLBCL) 2. Low-intermediate, high-intermediate or high risk NHL according to age-adjusted International Prognostic Index (IPI) score 3. NHL must be CD20 positive 4. Age 65 years or more 5. WHO performance status zero to two 6. Written informed consent
Key exclusion criteria	1. Intolerance of exogenous protein administration 2. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II to IV) or Left Ventricular Ejection Fraction (LVEF) less than 45% 3. Significant renal dysfunction (serum creatinine greater than or equal to 150 mmol/l), unless related to NHL 4. Significant hepatic dysfunction (total bilirubin greater than or equal to 30 mmol/l or transaminases greater than or equal to 25 times normal level), unless related to NHL 5. Suspected or documented Central Nervous System involvement by NHL 6. Patients known to be Human Immunodeficiency Virus (HIV)-positive 7. Patients with active, uncontrolled infections 8. Patients with uncontrolled asthma or allergy, requiring steroid treatment or treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localised lymphoma mass or infiltration 9. Story of active cancer during the past five years, except basal carcinoma of the skin or stage zero cervical carcinoma
Date of first enrolment	28/11/2001
Date of final enrolment	01/10/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus University Medical Centre

Rotterdam
3000 CA
Netherlands

Sponsor information

Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Research organisation

Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 2693
Email	hdc@hovon.nl
Website	http://www.hovon.nl/
"ROR"	https://ror.org/056kpdx27

Funders

Funder type

Research organisation

Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

20/08/2021: Proactive update review. No publications found. Search options exhausted.

A randomised phase III study of chimeric anti-CD20 monoclonal antibody (rituximab) with two-weekly CHOP chemotherapy (CHOP 14) in elderly patients with intermediate or high-risk non-Hodgkins lymphoma