Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT02499003
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥ 18 years
* Histologically proven diagnosis of diffuse large cell B-cell lymphoma (DLBCL), follicular lymphoma (FL) 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 (BM) 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
Exclusion Criteria:
* Lymphoma other than DLBCL, FL IIIB, transformed indolent Non-Hodgkin's lymphoma (NHL)
* Central nervous System (CNS) involvement (brain MRI (Magnetic resonance Imaging) 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, Ductal Carcinoma in Situ (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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02499003
Study Brief:
Protocol Section:
NCT02499003