Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
27/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 Hodgkin’s 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

http://www.erasmusmc.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

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

  1. 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.

Additional files

Editorial Notes