Randomized phase III study of Rituximab with intensified CHOP chemotherapy versus Rituximab with High-Dose Sequential Therapy and Autologous Stem Cell Transplantation in Adult Patients (18-65 years) with Stage II-IV High-intermediate or High Risk DLBCL
| ISRCTN | ISRCTN46136861 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46136861 |
| Secondary identifying numbers | HO63 |
- Submission date
- 13/01/2006
- Registration date
- 13/01/2006
- Last edited
- 24/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr G.W. Imhoff, van
Scientific
Scientific
University Medical Center Groningen
Department of Hematology
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 3612354 |
|---|---|
| g.w.van.imhoff@int.umcg.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HOVON 63 NHL |
| Study hypothesis | The hypothesis to be tested is that the outcome in arm B is better than in arm A. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Non Hodgkin's lymphoma (NHL) |
| Intervention | Patients will be randomized between: Arm A: 6 cycles of rituximab-iCHOP every 2 weeks plus G-CSF: pegfilgrastim (Neulasta®) Arm B: 3 cycles of rituximab-iCHOP every 2 weeks plus G-CSF: pegfilgrastim (Neulasta®), followed by rituximab-HDT Induction I, rituximab-HDT Induction II plus daily G-CSF: filgrastim (Neupogen®, SingleJect®), followed by BEAM with ASCT. Daily G-CSF: filgrastim (Neupogen® SingleJect®) will replace pegfilgrastim in the iCHOP chemotherapy cycle during which stem cells will be harvested. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rituximab, CHOP |
| Primary outcome measure | Event-free survival i.e. time from registration to induction failure (less than PR after 3 x R-iCHOP, no CR [Cru] after 6 RiCHOP [arm A] or ASCT [arm B]), death, progression or relapse whichever occurs first; the time to failure of patients with induction failure (less than PR after 3 x R-iCHOP) is set at one day. |
| Secondary outcome measures | 1. Complete response (including CRu) 2. Progression on protocol (progression or relapse after initial PR or CR during protocol treatment) 3. Overall survival measured form the time of registration 4. Disease-free interval (duration of the first CR) measured from the time of achievement of CR (including CRu) after protocol treatment to day of relapse or death from any cause (whichever occurs first) |
| Overall study start date | 28/10/2005 |
| Overall study end date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 250 |
| Participant inclusion criteria | 1. Patients with a confirmed histologic diagnosis of DLBCL according to the WHO classification 2. Ann Arbor stage II-IV 3. High-intermediate or high risk NHL according to age-adjusted IPI score (aa IPI = 2-3) 4. DLBCL must be CD20 positive 5. Age 18-65 years inclusive 6. WHO performance status </= 2 7. Negative pregnancy test (if applicable) 8. Written informed consent |
| Participant exclusion criteria | 1. Intolerance of exogenous protein administration 2. Severe cardiac dysfunction (NYHA classification II-IV) or LVEF <45% 3. Significant renal dysfunction (serum creatinine >/= 150 mumol/l), unless related to NHL 4. Significant hepatic dysfunction (total bilirubin >/= 30 mumol/l or transaminases >/= 2.5 times normal level), unless related to NHL 5. Suspected or documented Central Nervous System involvement by NHL 6. Testicular DLBCL 7. Primary mediastinal B cell lymphoma 8. Patients known to be HIV-positive 9. Patients with active, uncontrolled infections 10. Patients with uncontrolled asthma or allergy, requiring steroid treatment 11. Patient is a lactating woman 12. Unwillingness or not capable to use effective means of contraconception (all men and pre-menopausal women) 13. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of prednisone (<1 week) and/or cyclophosphamide (<1 week and not in excess of 900 mg/m2 cumulative) or local radiotherapy in order to control life threatening tumor related symptoms 14. History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma |
| Recruitment start date | 28/10/2005 |
| Recruitment end date | 01/01/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)
Research organisation
Research organisation
HOVON Data Center
Erasmus MC - Daniel den Hoed
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
| Phone | +31 (0)10 4391568 |
|---|---|
| hdc@erasmusmc.nl | |
| Website | http://www.hovon.nl/ |
"ROR" |
https://ror.org/056kpdx27 |
Funders
Funder type
Industry
Amgen, Johnson & Johnson - Orthobiotech, Dutch Cancer Society, Novartis Pharma B.V., Roche Nederland BV
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 |
