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 |
| Protocol serial number | Ho26 |
| Sponsor | Daniel den Hoed Kliniek (Erasmus Medical Centre) (The Netherlands) |
| Funders | Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands), The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (The Netherlands) |
- 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
Scientific
University Medical Centre Utrecht
Department of Haematology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 250 7230 |
|---|---|
| l.f.verdonck@azu.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo controlled, parallel group, multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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 |
| Study acronym | HOVON 26 NHL |
| Study objectives | The 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) studied | 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 / device / biological / vaccine name(s) | Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), and Granulocyte-Colony Stimulating Factor (G-CSF). |
| Primary outcome measure(s) |
CR rate and overall survival. |
| Key secondary outcome measure(s) |
1. Disease-free survival |
| Completion date | 01/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 513 |
| Total final enrolment | 477 |
| Key inclusion criteria | 1. Previously untreated patients with a primary Non Hodgkins 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 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 |
| Date of first enrolment | 11/11/1994 |
| Date of final enrolment | 01/04/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not 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.
