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Randomized phase III study on the effect of early intensification of rituximab in combination with 2-weekly CHOP chemotherapy followed by rituximab maintenance in elderly patients (66-80 years) with diffuse large B-cell lymphoma


- candidate number2653
- NTR NumberNTR1014
- ISRCTNISRCTN82286322
- Date ISRCTN created23-aug-2007
- date ISRCTN requested13-aug-2007
- Date Registered NTR3-jul-2007
- Secondary IDsHO84 
- Public TitleRandomized phase III study on the effect of early intensification of rituximab in combination with 2-weekly CHOP chemotherapy followed by rituximab maintenance in elderly patients (66-80 years) with diffuse large B-cell lymphoma
- Scientific TitleRandomized phase III study on the effect of early intensification of rituximab in combination with 2-weekly CHOP chemotherapy followed by rituximab maintenance in elderly patients (66-80 years) with diffuse large B-cell lymphoma
- ACRONYMHOVON 84 NHL
- hypothesisFirst randomization: The hypothesis to be tested is that the outcome in arm B (early intensification of rituximab combined with 2 weekly CHOP) is better than in arm A (no intensification of rituximab). Second randomization: The hypothesis to be tested is that the outcome in arm 2 (maintenance treatment with Rituximab) is better than in arm 1 (no futher treatment).
- Healt Condition(s) or Problem(s) studiedDiffuse large B-cell lymphoma
- Inclusion criteria1. Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma (DLBCL) based upon a representative histology specimen according to the WHO classification 2. DLBCL must be CD20 positive 3. Ann Arbor stages II-IV 4. ≥ 66 and 80 years 5. Age WHO performance status 0 2 6. Written informed consent
- Exclusion criteria1. Intolerance of exogenous protein administration 2. Severe cardiac dysfunction (NYHA classification III-IV or LVEF < 45%. Congestive heart failure or symptomatic coronary artery disease or cardiac arrhythmias not well controlled with medication. Myocardial infarction during the last 6 months 3. Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value) unless clearly related to NHL involvement 4. Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment 5. Significant hepatic dysfunction (total bilirubin ≥30mmol/l or transaminases ≥ 2.5 x upper normal limit), unless related to NHL 6. Significant renal dysfunction (serum creatinine ≥ 150 umol/l or clearance ≤ 60 ml/min), unless related to NHL 7. Clinical signs of severe cerebral dysfunction 8. Suspected or documented Central Nervous System involvement by NHL 9. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs 10. Testicular DLBCL 11. Primary mediastinal B cell lymphoma 12. Transformed indolent lymphoma 13. (EBV) post-transplant lymphoproliferative disorder 14. Secondary lymphoma after previous chemotherapy or radiotherapy 15. Major surgery, other than diagnostic surgery, within the last 4 weeks 16. Patients with active uncontrolled infections 17. Patients known to be HIV-positive 18. Active chronic hepatitis B or C infection 19. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease) 20. Life expectancy < 6 months 21. 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 22. 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-
- Studytypeintervention
- planned startdate 1-aug-2007
- planned closingdate31-mrt-2012
- Target number of participants550
- InterventionsArm A: 8 cycles of R-CHOP14 plus G-CSF: pegfilgrastim (Neulasta) Arm B 8 cycles of R-CHOP14 plus G-CSF: pegfilgrastim (Neulasta) with intensification of rituximab (MabThera) during the first 4 cycles. Arm 1: no further treatment Arm 2: maintenance treatment with rituximab (MabThera) once every 8 weeks until relapse (for a maximum period of 24 months)
- Primary outcomeFirst randomization: - Response rate (complete remission and FDG-PET negative partial remission or unconfirmed complete remission) Second randomization: - Failure free survival (measured from the date of second randomization)
- Secondary outcomeFirst randomization: - Failure free survival measured from the date of registration. Patients still alive or lost to follow up are censored at the last day they were known to be alive - Overall survival measured from the time of registration - Time to reach response - Toxicity Second randomization: - Overall survival - Toxicity
- Timepoints
- Trial web sitehttp://www.hovon.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. P.J. Lugtenburg
- CONTACT for SCIENTIFIC QUERIESDr. P.J. Lugtenburg
- Sponsor/Initiator HOVON Data Center
- Funding
(Source(s) of Monetary or Material Support)
Amgen, Dutch Cancer Society, Novartis Pharma B.V., Johnson&Johnson-Orthobiotech, Roche Diagnostics
- Publications-
- Brief summaryStudy phase: Phase III Study objectives: To evaluate the efficacy of: - early intensification of rituximab combined with 2-weekly CHOP+G-CSF (R-CHOP14) in remission induction treatment in comparison to standard R-CHOP14; - maintenance treatment with rituximab in patients in remission after R-CHOP14 in comparison to no further treatment. Patient population: Patients with stage II-IV diffuse large B-cell lymphoma (DLBCL), CD20 positive, previously untreated, age 66-80 years and WHO performance status 0-2. Study design: Prospective, multi center, randomized. Duration of treatment: Expected duration of remission induction treatment is 16 weeks. For patients randomized to maintenance treatment the additional treatment time is 2 years
- Main changes (audit trail)
- RECORD3-jul-2007 - 27-aug-2007


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