relapsed or refractory Chronic Lymphocytic Leukemia MedDRA version: 9.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia
Conditions
Interventions
Product Name: FBTA05
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: FBTA05
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration
Sponsors
Fresenius Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be enrolled in this study only if they meet all of the following criteria: • Signed and dated informed consent form. • Male or female • > = 18 years of age • Confirmed B-CLL based on standard histological or immunophenotypical criteria described in the WHO classification of lymphoid malignancies • CD20+ (if not already confirmed) • Relapsed/refractory active disease after at least two prior treatments requiring further therapy • Eastern Cooperative Oncology Group (ECOG) performance score of = 25,000/mm³ (= 25 x 10^9/l) • Serum glutamic oxaloacetic transaminase (SGOT/aspartate aminotransferase [AST]) and serum glutamic pyruvate transaminase [SGPT]/alanine aminotransferase [ALT]) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will not be enrolled in this study if they meet any of the following criteria: • Women who are pregnant or breast feeding. • Known active HIV infection. • AIDS related lymphoma • Leptomeningeal involvement • Unable or unwilling to comply fully with the protocol • History of allogeneic stem cell transplantation • Second active malignant disease, currently requiring treatment (not including basal cell carcinoma or curative surgery treated tumor) • Documented acute or chronic infection or other concurrent non-malignant co-morbidities that are uncontrolled • Known or suspected hypersensitivity to recombinant/murine proteins • Any autoimmune disease • History of respiratory insufficiency • Patients participating in a concurrent clinical trial or treated with experimental therapy within 30 days prior to the first administration of FBTA05 • Clinical conditions equal to protocol definitions of DLT • Any condition which in the judgment of the Investigator would place the subject at undue risk or interfere with the results of the study • Patients put into an institution by the authorities of judicial court
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Evaluation of safety and pharmacokinetic and pharmacodynamic relationship of the drug, and determination of further efficacy data in terms of time to progression (TTP), duration of response and clinical benefit.;Primary end point(s): The primary endpoint in Phase I, dose escalation, is the incidence of dose limiting toxicities (DLTs). The primary endpoint in Phase II, efficacy, is the objective response rate (ORR). ;Main Objective: Phase I, Dose escalation • determination of the maximum tolerated dose (MTD) of FBTA05 in patients with relapsed or refractory chronic lymphocytic leukemia (B-CLL). Phase II, Efficacy • evaluation of the preliminary efficacy of FBTA05 in patients with relapsed or refractory chronic lymphocytic leukemia with regard to objective response rate (CR, PR) | — |
Countries
Germany
Outcome results
None listed