Phase I/II dose-escalation study of the investigational trifunctional bispecific anti-CD20 x anti-CD3 antibody FBTA05 in relapsed or refractory chronic lymphocytic leukemia
- Conditions
- relapsed or refractory Chronic Lymphocytic LeukemiaMedDRA version: 9.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemia
- Registration Number
- EUCTR2006-006694-24-DE
- Lead Sponsor
- Fresenius Biotech GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 < = 2
•Adequate hematological, liver and kidney function:
•Platelet count > = 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]) < = 2.5 x upper limit of normal (ULN)
•Total bilirubin < = 1.5 x ULN
•Creatinine < = 1.5 x ULN
•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)
In addition, the following therapies must be discontinued at the given time points:
•Alemtuzumab, Rituximab or autologous stem transplantation must be
discontinued at least 3 months prior to Visit 1
•Any anti-cancer therapy must have been discontinued at least 4 weeks prior to
Visit 1
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).<br><br>The primary endpoint in Phase II, efficacy, is the objective response rate (ORR).<br>;Main Objective: Phase I, Dose escalation<br>•determination of the maximum tolerated dose (MTD) of FBTA05 in patients with relapsed or refractory chronic lymphocytic leukemia (B-CLL).<br>Phase II, Efficacy<br>•evaluation of the preliminary efficacy of FBTA05 in patients with relapsed or refractory chronic lymphocytic leukemia with regard to objective response rate (CR, PR)<br>
- Secondary Outcome Measures
Name Time Method