GOAL: GA101 Plus Pixantrone for Relapsed Aggressive Lymphoma
Sponsored by Johannes Gutenberg University Mainz
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 4 years ago
What is this trial about?
What are the participation requirements?
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.