Intensified CHOP of 12-weeks duration plus G-CSF as compared with standard CHOP of 24-weeks duration for patients with intermediate prognosis non-Hodgkin's lymphoma

ISRCTN ISRCTN11397785
DOI https://doi.org/10.1186/ISRCTN11397785
Secondary identifying numbers Ho26
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
09/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr L F Verdonck
Scientific

University Medical Centre Utrecht
Department of Haematology
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone +31 (0)30 250 7230
Email l.f.verdonck@azu.nl

Study information

Study designRandomised, placebo controlled, parallel group, multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleIntensified CHOP of 12-weeks duration plus G-CSF as compared with standard CHOP of 24-weeks duration for patients with intermediate prognosis non-Hodgkin's lymphoma
Study acronymHOVON 26 NHL
Study objectivesThe hypothesis to be tested is that the outcome in arm B is better than in arm A.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedNon Hodgkin's lymphoma (NHL)
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), and Granulocyte-Colony Stimulating Factor (G-CSF).
Primary outcome measureCR rate and overall survival.
Secondary outcome measures1. 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 study start date11/11/1994
Completion date01/04/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants513
Total final enrolment477
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment11/11/1994
Date of final enrolment01/04/2004

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Daniel den Hoed Kliniek (Erasmus Medical Centre) (The Netherlands)
Hospital/treatment centre

P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Phone +31 (0)10 439 1568
Email hdc@erasmusmc.nl
Website http://www.erasmusmc.nl/
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Research organisation

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

No information available

The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/04/2007 Yes No

Editorial Notes

09/11/2022: Total final enrolment added.