Obinutuzumab (GA101) in combination with PixantrOne for the treatment of patients with relapsed Aggressive B-cell Lymphoma
- Conditions
- 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 populationTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-004780-21-DE
- Lead Sponsor
- niversity Medical Center of the Johannes Gutenberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- 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, 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
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
-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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method