Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Technical University of Munich
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient´s written informed consent
≥ 18 years of age; male and female
Confirmed CLL, low grade NHL or high grade NHL on standard histological or immunophenotypical criteria described in the WHO classification of lymphoid malignancies
CD20 positivity (if not already confirmed)
Adequate haematological, liver and kidney functions
Platelet count ≥25,000mm³ (=25 x 10\^9/l)
Patients with active disease (relapsed/refractory) that survived at least 60 days after allogeneic transplantation
Eastern Cooperative Oncology Group (ECOG) performance status \<=2 (Appendix IV)
Negative pregnancy test (no more than 2 days before enrolment) and adequate contraception during the study in women of child bearing potential (pre- menopausal, \<2 years post-menopausal or not surgically sterile)
You may not be if
Any anti-CD20 and / or any other anti-T cell directed antibody treatments \< 3 months before application of FBTA05
Positivity for human anti-mouse antibodies (HAMAs)
History of GvHD ° III or IV, or GvHD requiring steroid therapy with more than 10 mg/day
Known or suspected hypersensitivity to recombinant, murine or rat proteins
AST/SGOT greater than 10 x ULN (grade 3, CTCAE)
Bilirubin greater than 5 x ULN (grade 3, CTCAE)
Creatinine greater than 3.5 mg/dl (grade 3, CTCAE)
Acute or uncontrolled chronic infections, viral infections at risk of reactivation (e.g.HCV, HBV, HIV)
Unable or unwilling to comply fully with the protocol
Any condition which in the judgement of the Investigator would place the subject at undue risk or interfere with the results of the study
