Diffuse large B-cell lymphoma MedDRA version: 20.0 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: Marqibo
Product Code: L01CA02
Pharmaceutical Form: Dispersion for infusion
INN or Proposed INN: vincristine sulphate
CAS Number: N/A
Other descriptive name: vincristine sulphate, liposom
Sponsors
Universität des Saarlandes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Elderly patients (61-80 years) with newly diagnosed aggressive CD20+ B-NHL. All risk groups with good general condition (ECOG 0-2) without majour accompanying diseases after patient's information and written patient's informed consent Please note: only favourable patients (IPI = 1 (age)) without bulk can be included as recruitment goal for less favourable patients has been reached. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1152
Exclusion criteria
Exclusion criteria: Already initiated lymphoma therapy ; Serious accompanying disorder or impaired organ function; Platelets <75 000/mm3, leukocytes <2 500/mm3; Known hypersensitivity to the medications to be used; Known HIV-positivity; Chronic active hepatitis; Poor patient compliance; Simultaneous participation in other treatment studies or in another clinical trial; Prior chemo- or radiotherapy, long-term use of corticosteroids or anti-neoplastic drugs for previous disorder; CNS involvement of lymphoma; Persistent neuropathy grade =2 (unless due to lymphoma involvement) ;Pregnancy or breast-feeding women Persons depending on sponsor or investigator Persons from highly protected groups.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Patients with less favourable prognosis: 1:To test whether progression-free survival (PFS) can be improved by substituting conventional by liposomal vincristine; 2:To test whether PFS can be improved by 12 optimised applications instead of 8 2-week applications of rituximab Patients with favourable pro¬gnosis: 3:Comparison of neurotoxicity of conventional and liposomal vincristine; 4:Determination of PFS for the treatment strategy of reducing treatment in patients with negative FDG-PET after 4 x R-CHOP/CHLIP-14 (PET-4) and comparison with the corresponding patient population in RICOVER-60. ;Secondary Objective: Comparison of the efficacy and toxicity of the individualised (post-induction therapy FDG-PET-based) treatment strategy in OPTIMAL>60 with the fixed (pre-defined) treatment strategy in RICOVER-60. Estimation of the vincristine related neurotoxicity (less favourable patients only) and other toxicities in the favourable and less favourable group Determination of the therapeutic efficacy of a vitamin D substitution comparing the first cohort of patients without vitamin D substitution with those patients who receive a vitamin D substitution. This shall be investigated for Vit D levels at baseline and longitudinally according to substitution and gender Comparison of the vincristine related neurotoxicity before and after amendment Comparison of CNS events before and after amendment #4 including toxicity For further secondary objectives, please refer to chapter 16.1 of the protocol;Primary end point(s): Progression free survival. PFS is defined by the time between the day of randomisation until one of the following events occurs, whichever comes first: -Disease progression (PD) -Relapse after achieving CR -Progression after PR, NC or unknown -Death due to any cause. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment ;Timepoint(s) of evaluation of this end point: | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): for efficacy: rate of complete remissions (CR rate), rate of partial responses (PR rate), rate of primary progressions, relapse rate, event-free survival (EFS) and overall survival (OS); rate and CTC grades of polyneuropathy. Prognostic value of the FDG-PET derived imaging biomarkers for lymphoma load: SUV (standardized uptake value), SUR (standardized uptake ratio), metabolic tumor volume (MTV), total lesion glycolysis (TLG), SUR-derived TLG (TLGSUR). Different reference pathology biomarkers from tumor tissue and circulating tumor DNA in the plasma for detailed information cf chapter 4.3.1;Timepoint(s) of evaluation of this end point: for efficacy and FDG-PET derived Imaging biomarkers: during the restagings and the follow-up assessments as planned in the protocol (cf. chapter 8.11 of the protocol). The incidence and rates of polyneuropathy will additionally be assessed before each cycle of chemotherapy. Assessment of ctDNA: before each cycle of CHOP/CHLIP, at restaging after completion of therapy, and at each follow-up during the first two years after the end of treatment. | — |
Countries
Germany
Contacts
Public ContactCentral Study Office
Universität des Saarlandes
Outcome results
None listed