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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Stem Cell Transplantation

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Determination of the maximum tolerated dose (MTD)

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

STP-LYM-01-V01

NCT ID:

NCT01138579

Start Date:

August 2010

Completion Date:

Related Keywords:

  • Leukemia
  • Stem Cell Transplantation
  • 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
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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