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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)

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ClinicalTrials.gov Identifier: NCT01138579
Recruitment Status : Terminated (Recruitment delayed, trial medication no loner available)
First Posted : June 7, 2010
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Tracking Information
First Submitted Date  ICMJE June 4, 2010
First Posted Date  ICMJE June 7, 2010
Last Update Posted Date April 26, 2016
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2010)
  • Phase I: Determination of the maximum tolerated dose (MTD)
  • Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01138579 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Trifunctional Antibody FBTA05 and Donor Lymphocyte Infusion in B-cell Lymphoma After Allogeneic Stem Cell Transplantation
Official Title  ICMJE 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
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 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • Stem Cell Transplantation
Intervention  ICMJE Drug: FBTA05
Study Arms  ICMJE Experimental: 1
Intervention: Drug: FBTA05
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 2, 2015)
9
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01138579
Other Study ID Numbers  ICMJE STP-LYM-01-V01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Technische Universität München
Study Sponsor  ICMJE Technische Universität München
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Technische Universität München
Verification Date December 2015

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