marginal zone B-cell lymphomas (MZL) MedDRA version: 14.1 Level: PT Classification code 10029463 Term: Nodal marginal zone B-cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10029464 Term: Nodal marginal zone B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Arzerra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
SENDO TECH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 18 2. Histologically proven diagnosis of marginal zone B-cell lymphoma relapsing/refractory following at least 1 prior systemic treatment (chemotherapy and/or monoclonal antibodies) 3. Any stage (Ann Arbor I-IV) 3. Life expectancy of at least 6 months and ECOG performance status 0-1 4. No evidence of histological transformation to diffuse large cells lymphoma 5. Adeguate bone marrow function, renal function or liver function 6. Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment 2. Treatment with anti-CD20 monoclonal antibody or alemtuzumab within 8 weeks prior to the enrollment 3. Treatment with corticosteroids during the last 4 weeks 4.Other past or current malignancy 5. Previous organ transplantation 6.Clinically significant cardiac or pulmonary disease 7.History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequele 8. Concomitant infectious diseases, HIV positive, Hepatitis B or C positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy (Overall Remission Rate) of ofatumumab and bendamustine in relapsed or refractory marginal zone B-cell lymphomas;Secondary Objective: - Duration of antitumor activity - Safety profile - Feasibility of the combination;Primary end point(s): Overall response rate (CR+PR), defined according to Cheson criteria (Cheson et al 2007). For patients with splenic MZL response is defined according to Matutes et al. 2008 and for patients with gastric lymphomas histological response is evaluated according to GELA scoring system (Copie-Bergman et al 2003);Timepoint(s) of evaluation of this end point: CT-scan at the end of cycle 2 and at F-up 1 (4 mos), F-up 2 (8 mos) e F-up 3 (24 mos) after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Two years Progression Free Survival (PFS) - Time to next treatment - Adverse events according to NCI-CTC V3;Timepoint(s) of evaluation of this end point: - PFS: 2 years after the end of the treatment. - Time to next treatment. - Time to relapse. - Continuous evaluation of AE. | — |
Countries
Italy, Switzerland
Contacts
Public ContactDirezione Scientifica
SENDO-TECH Srl
Outcome results
None listed