Relapsed malignant B-cell lymphoma - CD 20 positive disease - Entities: - Diffuse large B-cell Lymphoma - Follicular lymphoma grade IIIB - Transformed indolent lymphoma up to 20% of the patient population
Conditions
Interventions
Trade Name: GAZYVARO™
Product Name: Obinutuzumab
Product Code: RO5072759/F06-01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Obinutuzumab
CAS Number: 949142-50-1
Oth
Sponsors
University Medical Center of the Johannes Gutenberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged = 18 years - Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review) - Relapsed disease - Eastern Cooperative Oncology Group [ECOG] performance Status =2, unless tumor associated - Adequate cardiac reserve: Serum Troponin level must be consistent with no significant acute or chronic myocardial damage and there should be no evidence of symptomatic disease - No curative option available - At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration - Adequate bone marrow reserve: Platelets of at least 100.000/µl, absolute neutrophil count of at least 1000/µl. Adequate hepatic and renal function: Alanine aminotransferase 30 mL/min - Fresh tumor biopsy or archived tissue available - Ability of patients to understand nature, importance and individual consequences of clinical trial. - Signed informed consent - Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (serum or urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment. Reliable contraception comprises systematic contraceptives (oral, implant, injection) or diaphragm / condoms / intrauterine devices (IUP) with spermicide. - Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: - Lymphoma other than DLBCL, FL IIIB, transformed indolent NHL - CNS involvement (brain MRI is required only in cases of clinically suspicious involvement) - Pregnant or breast-feeding women - Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinaemia) - Myocardial infarction within the last 6 months - Active uncontrolled infections including HIV-positivity, active Hepatitis B or C - Vaccination with live vaccine within last 4 weeks - Mental status precluding patient’s compliance - Known CD20 negativity - Diagnosed or treated for a malignancy other than NHL except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, DCIS of the breast, or other solid tumors curatively treated with no evidence of disease for >3 years, or prostate cancer with a life expectancy of more than 2 years - Treatment with any approved anticancer agent within last 2 weeks. Any agents must have been stopped at least 2 weeks prior to day 1 of GOAL treatment and all treatment related adverse events must have returned to Grade 1. - Prior exposition to Obinutuzumab or Pixantrone - History of hypersensitivity to medicinal products with similar chemical structure as the trial medication - Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation. Concurrent participation in non-treatment studies is not excluded - Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the overall response rate (ORR) of the combination after completion or termination of trial treatment;Secondary Objective: - To evaluate safety/toxicity - To evaluate remission duration and survival ;Primary end point(s): The primary endpoint is the ORR of the regimen at cycle 6 or the individual treatment end.;Timepoint(s) of evaluation of this end point: Active treatment with Obinutuzumab and Pixantrone for 6 cycles will last approximately to a maximum of 24 weeks. Response will be assessed 4 weeks after completion of treatment. In patients with early termination the appropriate response evaluation will be used. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rate of adverse events / Tolerability - Progression free survival - Overall survival - ORR in separate GCB vs. non GCB-analysis is planned (GEP-profiling) ;Timepoint(s) of evaluation of this end point: Active treatment with Obinutuzumab and Pixantrone for 6 cycles will last approximately to a maximum of 24 weeks. Response will be assessed 4 weeks after completion of treatment. Patients will be followed for disease progression and or death and initiation of subsequent therapy for B-cell lymphoma for at least 2 years (if no event occurs) up to a maximum of 3 years. | — |
Countries
Germany
Contacts
Public ContactGeorg Hess
University Medical Center of the Johannes Gutenberg
Outcome results
None listed