Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
05/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hovon.nl

Contact information

Type

Scientific

Primary contact

Prof P Sonneveld

ORCID ID

Contact details

Erasmus University Medical Centre
Department of Haematology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 3589
p.sonneveld@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Ho46

Study information

Scientific title

Acronym

HOVON 46 NHL

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised, active 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: 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

Phase

Phase III

Drug names

Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone and granulocyte colony stimulating factor.

Primary outcome measures

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 trial start date

28/11/2001

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

400

Participant 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

Recruitment start date

28/11/2001

Recruitment end date

01/10/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus University Medical Centre
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

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

Sponsor details

Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2693
hdc@hovon.nl

Sponsor type

Research organisation

Website

http://www.hovon.nl/

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

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

Publication citations

Additional files

Editorial Notes