Effect of recombinant Granulocyte Colony-Stimulating Factor (G-CSF) on the results of chemotherapy (CHOP) in elderly patients with intermediate-/high-grade Non-Hodgkin's Lymphoma: a prospective phase III study

ISRCTN	ISRCTN26340837
DOI	https://doi.org/10.1186/ISRCTN26340837
Protocol serial number	HO25
Sponsor	Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Funders	Johnson & Johnson (The Netherlands), Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands), Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) (The Netherlands), Roche Nederland B.V. (The Netherlands), Amgen (The Netherlands), Novartis Pharma B.V. (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Multicentre, randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	HOVON 25 NHL
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Granulocyte Colony-Stimulating Factor (G-CSF), cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)
Primary outcome measure(s)	Complete Remission (CR) rate.
Key secondary outcome measure(s)	1. Relapse rate 2. Event-free survival 3. Overall survival 4. Treatment-related morbidity 5. Therapy-related hospital admissions 6. Mortality
Completion date	05/09/2000

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	410
Key inclusion criteria	1. Previously untreated Non-Hodgkins 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
Key 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
Date of first enrolment	01/08/1994
Date of final enrolment	05/09/2000

Erasmus University Medical Centre

Rotterdam
3000 CA
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	15/08/2003		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes