Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
09/11/2007
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

HO25

Study information

Scientific title

Acronym

HOVON 25 NHL

Study hypothesis

The hypothesis to be tested is that the outcome in arm B is better than in arm A.

Objectives:
1. Evaluation of the effect of G-CSF on response and survival of Non-Hodgkin's Lymphoma (NHL) to therapy
2. Evaluation of the effect of prophylactic G-CSF on treatment-related morbidity and mortality
3. Evaluation of possible beneficial effect of G-CSF on patient adherence to Relative Dose Intensity of the standard therapy.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Non Hogdkin's Lymphoma (NHL)

Intervention

Patients will be randomised at entry between:
Arm A: CHOP every 3 weeks, 6 or 8 courses
Arm B: CHOP every 3 weeks, 6 or 8 courses and 300 mcg subcutaneous (s.c.) daily G-CSF

CHOP consists of cyclophosphamide, doxorubicin, vincristine and prednisone.

Intervention type

Drug

Phase

Phase III

Drug names

Granulocyte Colony-Stimulating Factor (G-CSF), cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)

Primary outcome measures

Complete Remission (CR) rate.

Secondary outcome measures

1. Relapse rate
2. Event-free survival
3. Overall survival
4. Treatment-related morbidity
5. Therapy-related hospital admissions
6. Mortality

Overall trial start date

01/08/1994

Overall trial end date

05/09/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Previously untreated Non-Hodgkin’s Lymphoma
2. Ann Arbor stage II, III or IV
3. Intermediate- or high grade malignancy (Working Formulation), confirmed by histology
4. Aged greater than or equal to 65 years
5. Informed consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

410

Participant exclusion criteria

1. Treatment for NHL with chemotherapy or radiotherapy (local irradiation to life-threatening tumor infiltration is allowed)
2. Lymphoblastic lymphoma
3. Other malignant diseases, except localized squamous skin carcinoma
4. Severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%
5. Inadequate liver or renal function, ie serum creatinine or serum bilirubin > 15x the upper normal value, except when related to lymphoma organ infiltration
6. HIV positivity

Recruitment start date

01/08/1994

Recruitment end date

05/09/2000

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

Industry

Funder name

Johnson & Johnson (The Netherlands)

Alternative name(s)

Johnson & Johnson, JNJ

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Roche Nederland B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Amgen (The Netherlands)

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Novartis Pharma B.V. (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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=12915593

Publication citations

  1. Results

    Doorduijn JK, van der Holt B, van Imhoff GW, van der Hem KG, Kramer MH, van Oers MH, Ossenkoppele GJ, Schaafsma MR, Verdonck LF, Verhoef GE, Steijaert MM, Buijt I, Uyl-de Groot CA, van Agthoven M, Mulder AH, Sonneveld P, CHOP compared with CHOP plus granulocyte colony-stimulating factor in elderly patients with aggressive non-Hodgkin's lymphoma., J. Clin. Oncol., 2003, 21, 16, 3041-3050, doi: 10.1200/JCO.2003.01.076.

Additional files

Editorial Notes