EUCTR2006-006694-24-DE
Active, not recruiting
Not Applicable
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
Fresenius Biotech GmbH0 sitesJanuary 2, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- relapsed or refractory Chronic Lymphocytic Leukemia
- Sponsor
- Fresenius Biotech GmbH
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \< \= 2
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
Outcomes
Primary Outcomes
Not specified
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