Rescue treatment with the monoclonal anti CD20-antibody Obinutuzumab (GA101) in combination with PixantrOne for the treatment of patients with relapsed Aggressive B-cell Lymphoma
- Conditions
- C85.1C83.3C82.4Diffuse large B-cell lymphomaFollicular lymphoma grade IIIbB-cell lymphoma, unspecified
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 70
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 (in case of extensive BM-infiltration 75.000/µl may be acceptable after discussion with the coordinating investigator), absolute neutrophil count of at least 1000/µl. Adequate hepatic and renal function: Alanine aminotransferase <2.5 x upper limit of normal (ULN); Aspartate aminotransferase <2.5 x ULN, total bilirubin <1.5 x ULN
-No active Hepatitis B or C or HIV-infection
-Measured or calculated creatinine clearance >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
-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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the ORR of the regimen at cycle 6 or the individual treatment end tested in the entire cohort of patients (30 weeks). <br>The response to treatment is measured by results of computer tomography (CT) for measurable lesions and evaluation for non-measurable lesions after cycle 6 or at the individual end of treatment.
- Secondary Outcome Measures
Name Time Method -Safety of the combination treatment as measured by the rate of adverse events, which reflects tolerability of the treatment (30 weeks)<br>- Percentage of patients completing the entire trial treatment (30 weeks)<br>- Evaluation of best response to trial treatment as measured as best response either during or post the entire treatment (up to 3 years)<br>-Progression free survival (up to 3 years)<br>-Overall survival (up to 3 years)<br>-ORR in separate GCB vs. non GCB-analysis is planned (GEP-profiling) (30 weeks)<br>