Status:
WITHDRAWN
Study of the Trifunctional Antibody FBTA05 and Donor Lymphocyte Infusion in B-cell Lymphoma After Allogeneic Stem Cell Transplantation
Lead Sponsor:
Technical University of Munich
Conditions:
Leukemia
Stem Cell Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is an investigator driven, open-label, non-randomized, uncontrolled, dose escalating Phase I/II study evaluating the safety and preliminary efficacy of the trifunctional bispecific antibody...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01138579
Start Date
August 1 2010
End Date
June 1 2015
Last Update
December 7 2022
Active Locations (1)
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1
3. Medizinische Klinik, Klinikum rechts der Isar der TU München
Munich, Bavaria, Germany