diffuse large B-cell lymphoma MedDRA version: 21.0 Level: LLT Classification code 10012820 Term: Diffuse large B-cell lymphoma NOS System Organ Class: 100000004864
Conditions
Interventions
Product Name: prednisone
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product
Sponsors
HOVON Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For first randomization: - Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma (DLBCL) based upon a representative histology specimen according to the WHO classification (see appendix A) - DLBCL must be CD20 positive - Ann Arbor stages II-IV (see appendix C) - Age 18-65 years and age-adjusted IPI 1-3 OR age 66-80 years and age-adjusted IPI 0-3 - WHO performance status 0 – 2 (see appendix E) - Written informed consent For second randomization: Patients achieving a CR (or FDG-PET negative PR/CRu) after 6 (elderly) or 8 (young patients) cycles of R-CHOP14 will be randomized to maintenance treatment with rituximab or no further treatment. - Patients in complete remission or FDG-PET negative partial remission/unconfirmed complete remission at least 4 weeks after the last cycle of R-CHOP14 (including last rituximab administration) - Time interval since last cycle of R-CHOP14 (including last rituximab administration) between 4 and 8 weeks - No rituximab-related adverse event necessitating stopping of rituximab administration - No active infection - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: -Age 18-65 (inclusive) years and aa-IPI 0 (no risk factors) -Intolerance of exogenous protein administration -Severe cardiac dysfunction (NYHA classification III-IV, see appendix F) or LVEF = 30mmol/l or transaminases >= 2.5 x upper normal limit), unless related to NHL - Significant renal dysfunction (serum creatinine >= 150 umol/l or clearance <= 60 ml/min), unless related to NHL - Clinical signs of severe cerebral dysfunction - Suspected or documented Central Nervous System involvement by NHL - 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 - Testicular DLBCL - Primary mediastinal B cell lymphoma - Transformed indolent lymphoma - (EBV) post-transplant lymphoproliferative disorder - Secondary lymphoma after previous chemotherapy or radiotherapy - Major surgery, other than diagnostic surgery, within the last 4 weeks - Patients with active uncontrolled infections - Patients known to be HIV-positive - Active chronic hepatitis B or C infection - 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) - Life expectancy < 6 months - 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 - History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess in a prospective, multicenter, randomized phase III study in patients with DLBCL the effect of early intensification of rituximab combined with 2-weekly CHOP +G-CSF (CHOP14) in comparison to no intensification of rituximab on the response rate (complete remission and FDG-PET negative partial remission/unconfirmed complete remission) and time to reach response ;Secondary Objective: To assess in a prospective, multicenter, randomized phase III study in patients with DLBCL the efficacy of maintenance treatment with rituximab in comparison to no further treatment on failure free survival ;Primary end point(s): Response rate (complete remission and FDG-PET negative partial remission or unconfirmed complete remission) ;Timepoint(s) of evaluation of this end point: 200 and 400 evaluable patients and end of trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -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;Timepoint(s) of evaluation of this end point: end of trial | — |
Countries
Belgium, Denmark, Netherlands
Contacts
Public ContactHOVON Data Center
Erasmus MC
Outcome results
None listed