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

This study is currently recruiting participants.
Verified November 2013 by Technische Universität München
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01138579
First received: June 4, 2010
Last updated: November 27, 2013
Last verified: November 2013

June 4, 2010
November 27, 2013
August 2010
December 2014   (final data collection date for primary outcome measure)
  • Phase I: Determination of the maximum tolerated dose (MTD)
  • Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI
Same as current
Complete list of historical versions of study NCT01138579 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
 
Recruiting
30
Not Provided
December 2014   (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
No
Contact: Elisabeth Lindner-Pöppl, MSc +49 (0)89-4140 ext 6328 elisabeth.lindner-poeppl@mri.tum.de
Contact: Elisabeth André, Dr. +49 (0)89-4140 ext 6326 elisabeth.andre@mri.tum.de
Germany
 
NCT01138579
STP-LYM-01-V01
Yes
Not Provided
Technische Universität München
Not Provided
Not Provided
Technische Universität München
November 2013

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