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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

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

Condition or disease Intervention/treatment Phase
Leukemia Stem Cell Transplantation Drug: FBTA05 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2010
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: 1 Drug: FBTA05



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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138579


Locations
Germany
3. Medizinische Klinik, Klinikum rechts der Isar der TU München
Munich, Bavaria, Germany
Sponsors and Collaborators
Technische Universität München

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01138579     History of Changes
Other Study ID Numbers: STP-LYM-01-V01
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: December 2015

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
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid
Antibodies
Immunologic Factors
Physiological Effects of Drugs