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Randomized phase III study of Rituximab with intensified CHOP chemotherapy vs. Rituximab with High-Dose Sequential Therapy and Autologous Stem Cell Transplantation in Adult Patients (18-65 yrs) with Stage II-IV High-intermediate or High Risk DLBCL.


- candidate number0
- NTR NumberNTR556
- ISRCTNISRCTN46136861
- Date ISRCTN created13-jan-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR13-sep-2005
- Secondary IDsHO63 
- Public TitleRandomized phase III study of Rituximab with intensified CHOP chemotherapy vs. Rituximab with High-Dose Sequential Therapy and Autologous Stem Cell Transplantation in Adult Patients (18-65 yrs) with Stage II-IV High-intermediate or High Risk DLBCL.
- Scientific TitleRandomized phase III study of Rituximab with intensified CHOP chemotherapy (R-iCHOP-14) versus Rituximab with High-Dose Sequential Therapy and Autologous Stem Cell Transplantation (R-HDT+ASCT) in Adult Patients (18-65 yrs) with Stage II-IV High-intermediate or High Risk Diffuse Large B-Cell Lymphoma.
- ACRONYMHOVON 63 NHL
- hypothesisThe hypothesis to be tested is that the outcome in arm B is better than in arm A.
- Healt Condition(s) or Problem(s) studiedNon Hodkin's lymfoma (NHL)
- Inclusion criteria1. 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.
- Exclusion criteria1. Intolerance of exogenous protein administration; 2. Severe cardiac dysfunction (NYHA classification II-IV, Appendix F) 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 anticonception (all men and pre-menopausal women); 13. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of prednisone (< 1 wk) and/or cyclophosphamide (< 1 wk 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 28-okt-2005
- planned closingdate1-jan-2009
- Target number of participants250
- InterventionsPatients will be randomized between: - Arm A: 6 cycles of rituximab-iCHOP q 2 weeks plus G-CSF: pegfilgrastim (Neulasta®) - Arm B: 3 cycles of rituximab-iCHOP q 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.
- Primary outcomeEvent-free survival (i.e. time from registration to induction failure (i.e. 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 outcome1. 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).
- Timepoints
- Trial web sitehttp://www.hovon.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES G.W. Imhoff, van
- CONTACT for SCIENTIFIC QUERIES G.W. Imhoff, van
- Sponsor/Initiator Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Funding
(Source(s) of Monetary or Material Support)
Amgen, Dutch Cancer Society, Roche Nederland BV, Novartis Pharma B.V., Johnson&Johnson-Orthobiotech
- PublicationsN/A
- Brief summarySTUDY PHASE: phase III STUDY OBJECTIVE: evaluation of the effect of 6 x intensified CHOP + 8 x rituximab (R-iCHOP-14) v. 3 x intensified CHOP + 8 x rituximab + High-dose sequential therapy with up-front Autologous Stem Cell Transplantation (R-HDT+ASCT) PATIENT POPULATION: patients with stage II-IV high-intermediate or high risk (age-adjusted IPI:2-3) diffuse large B-cell lymphoma (DLBCL), CD20 positive, previously untreated, age 18-65 years inclusive and WHO performance status 0-2 STUDY DESIGN: prospective, multicenter, randomized DURATION OF TREATMENT: expected duration of treatment is 12 weeks (Arm A) v. 16 weeks (Arm B).
- Main changes (audit trail)
- RECORD11-jan-2006 - 31-mrt-2008


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