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Study of the Trifunctional Antibody FBTA05 and Donor Lymphocyte Infusion in B-cell Lymphoma After Allogeneic Stem Cell Transplantation (STP-LYM-01)

This study has been terminated.
(Recruitment delayed, trial medication no loner available)
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01138579
First received: June 4, 2010
Last updated: April 25, 2016
Last verified: December 2015

June 4, 2010
April 25, 2016
August 2010
May 2016   (final data collection date for primary outcome measure)
  • Phase I: Determination of the maximum tolerated dose (MTD) [ Designated as safety issue: Yes ]
  • Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI [ Designated as safety issue: No ]
  • Phase I: Determination of the maximum tolerated dose (MTD)
  • Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI
Complete list of historical versions of study NCT01138579 on ClinicalTrials.gov Archive Site
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Study of the Trifunctional Antibody FBTA05 and Donor Lymphocyte Infusion in B-cell Lymphoma After Allogeneic Stem Cell Transplantation
Phase I/II Dose-escalation Study of the Investigational Trifunctional Bispecific Anti-CD20 x Anti-CD3 Antibody FBTA05 in Combination With Donor Lymphocyte Infusion (DLI) in Patients With CD20 Positive Chronic Lymphocytic Leukemia (CLL), Low and High Grade Non-Hodgkin´s Lymphoma (NHL) After Allogeneic Stem Cell Transplantation
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
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Stem Cell Transplantation
Drug: FBTA05
Experimental: 1
Intervention: Drug: FBTA05
Buhmann R, Michael S, Juergen H, Horst L, Peschel C, Kolb HJ. Immunotherapy with FBTA05 (Bi20), a trifunctional bispecific anti-CD3 x anti-CD20 antibody and donor lymphocyte infusion (DLI) in relapsed or refractory B-cell lymphoma after allogeneic stem cell transplantation: study protocol of an investigator-driven, open-label, non-randomized, uncontrolled, dose-escalating Phase I/II-trial. J Transl Med. 2013 Jul 2;11:160. doi: 10.1186/1479-5876-11-160.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
June 2016
May 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01138579
STP-LYM-01-V01
Yes
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Technische Universität München
Technische Universität München
Not Provided
Not Provided
Technische Universität München
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP