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. (see Contacts and Locations)
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
  Purpose

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


Condition Intervention Phase
Leukemia
Stem Cell Transplantation
Drug: FBTA05
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Phase I: Determination of the maximum tolerated dose (MTD)
  • Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI

Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: FBTA05

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138579

Contacts
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

Locations
Germany
3. Medizinische Klinik, Klinikum rechts der Isar der TU München Recruiting
Munich, Bavaria, Germany
Contact: Christian Peschel, Prof. Dr. med.    +49 (0)89-4140 ext 4111    christian.peschel@lrz.tu-muenchen.de   
Principal Investigator: Christian Peschel, Prof. Dr. med.         
Sub-Investigator: Raymund Buhmann, Dr. med.         
Sponsors and Collaborators
Technische Universität München
  More Information

No publications provided by Technische Universität München

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01138579     History of Changes
Other Study ID Numbers: STP-LYM-01-V01
Study First Received: June 4, 2010
Last Updated: November 27, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Technische Universität München:
FBTA05
CD20
CLL
NHL
DLI
allogeneic transplantation
CD20 positive chronic lymphocytic leukemia (CLL)
low and high grade non-Hodgkin´s lymphoma (NHL) after allogeneic stem cell transplantation with active disease

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on October 19, 2014