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 |
| Secondary identifying numbers | HO25 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 09/11/2007
- 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
Prof P Sonneveld
Scientific
Scientific
Erasmus University Medical Centre
Department of Haematology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 463 3589 |
|---|---|
| p.sonneveld@erasmusmc.nl |
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Granulocyte Colony-Stimulating Factor (G-CSF), cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) |
| Primary outcome measure | 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 study start date | 01/08/1994 |
| Completion date | 05/09/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus University Medical Centre
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Research organisation
Research organisation
Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 2693 |
|---|---|
| hdc@hovon.nl | |
| Website | http://www.hovon.nl/ |
"ROR" |
https://ror.org/056kpdx27 |
Funders
Funder type
Industry
Johnson & Johnson (The Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Johnson & Johnson, johnson & Johnson Services, Inc., Johnson&Johnson, 强生公司, Johnson & Johnson Private Limited, ジョンソン・エンド・ジョンソント, J&J, JNJ
- Location
- United States of America
Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)
No information available
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) (The Netherlands)
No information available
Roche Nederland B.V. (The Netherlands)
No information available
Amgen (The Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Amgen Inc., Applied Molecular Genetics Inc.
- Location
- United States of America
Novartis Pharma B.V. (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 15/08/2003 | Yes | No |
