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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01138579
Other study ID # STP-LYM-01-V01
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date August 2010
Est. completion date June 2015

Study information

Verified date December 2015
Source Technical University of Munich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 FBTA05 in combination with donor lymphocyte infusions (DLI) for treatment of relapsed or refractory disease in CD20 positive either low- or high-grade non-Hodgkin´s lymphoma after allogeneic transplantation


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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) - 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 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
FBTA05


Locations

Country Name City State
Germany 3. Medizinische Klinik, Klinikum rechts der Isar der TU München Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase I: Determination of the maximum tolerated dose (MTD)
Primary Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI
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