CD20 positive chronic lymphocytic leukemia (CLL) low and high grade non-Hodgkin´s lymphoma (NHL)
Conditions
Interventions
Product Code: FBTA05
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: FBTA05
Concentration unit: µg microgram(s)
Concentration type: up to
Concentration number: 10-300
Sponsors
Medizinische Fakultaet der Technischen Universitaet Muenchen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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); - Patients with relapsed / refractory disease that survived at least 60 days after allogeneic transplantation; - Eastern Cooperative Oncology Group (ECOG) performance status > 2 - Negative pregnancy test (no more than 2 days before enrolment) and adequate contraception during the study in women of child bearing potential (pre-menopausal, =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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; - Any condition which in the judgement of the Investigator would place the subject at undue risk or interfere with the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I, Dose escalation - Determination of the maximum tolerated dose (MTD) of FBTA05 in combination with DLI in patients with CLL/low grade NHL and high grade NHL. Phase II, Efficacy - Evaluation of preliminary efficacy of FBTA05 in combination with DLI in patients with CLL/low grade NHL and high grade NHL with regard to objective response rates (CR, PR, SD).;Secondary Objective: Evaluation of safety and pharmacodynamic relationship of FBTA05 in context with DLI, the induction of cellular immunity in terms of Graft vs. Leukemia / Lymphoma effects (GvL) or Graft vs. Host disease (GvHD) and the determination of further efficacy data in terms of time to progression (TTP), duration of response and clinical benefit.;Primary end point(s): Phase I, Dose escalation - Determination of the maximum tolerated dose (MTD) of FBTA05 in combination with DLI in patients with CLL/low grade NHL and high grade NHL. Phase II, Efficacy - Evaluation of preliminary efficacy of FBTA05 in combination with DLI in patients with CLL/low grade NHL and high grade NHL with regard to objective response rates (CR, PR, SD). | — |
Countries
Germany
Outcome results
None listed