Immunotherapy with the trifunctional anti-CD20 x anti-CD3 antibody FBTA05 (Lymphomun) in paediatric high-risk patients with recurrent CD20-positive B cell malignancies

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Immunotherapy with the trifunctional anti-CD20 x anti-CD3 antibody FBTA05 (Lymphomun) in paediatric high-risk patients with recurrent CD20-positive B cell malignancies. / Schuster, Friedhelm R; Stanglmaier, Michael; Woessmann, Wilhelm; Winkler, Beate; Siepermann, Meinolf; Meisel, Roland; Schlegel, Paul G; Hess, Jürgen; Lindhofer, Horst; Borkhardt, Arndt; Buhmann, Raymund.

in: BRIT J HAEMATOL, Jahrgang 169, Nr. 1, 04.2015, S. 90-102.

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@article{0bc042e694854210a1f3d3f29137bf79,
title = "Immunotherapy with the trifunctional anti-CD20 x anti-CD3 antibody FBTA05 (Lymphomun) in paediatric high-risk patients with recurrent CD20-positive B cell malignancies",
abstract = "Children with B cell malignancies refractory to standard therapy are known to have a poor prognosis and very limited treatment options. Here, we report on the treatment and follow-up of ten patients diagnosed with relapsed or refractory mature B-cell Non Hodgkin Lymphoma (B-NHL), Burkitt leukaemia (B-AL) or pre B-acute lymphoblastic leukaemia (pre B-ALL). All children were treated with FBTA05 (now designated Lymphomun), an anti-CD3 x anti-CD20 trifunctional bispecific antibody (trAb) in compassionate use. Within individual treatment schedules, Lymphomun was applied (a) after allogeneic stem cell transplantation (allo-SCT, n = 6) to induce sustained long-term remission, or (b) stand alone prior to subsequent chemotherapy to eradicate residual disease before allo-SCT (n = 4). Nine of ten children displayed a clinical response: three stable diseases (SD), one partial remission (PR) and five induced or sustained complete remissions (CR). Five of these nine responders died during follow-up. The other patients still maintain CR with a current overall survival of 874-1424 days (median: 1150 days). In conclusion, despite the dismal clinical prognosis of children refractory to standard therapy, immunotherapy with Lymphomun resulted in a favourable clinical outcome in this cohort of refractory paediatric patients.",
keywords = "Adolescent, Allografts, Antibodies, Bispecific/administration & dosage, Burkitt Lymphoma/mortality, Child, Child, Preschool, Disease-Free Survival, Female, Follow-Up Studies, Humans, Immunotherapy, Male, Neoplasm, Residual, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma/mortality, Stem Cell Transplantation, Survival Rate",
author = "Schuster, {Friedhelm R} and Michael Stanglmaier and Wilhelm Woessmann and Beate Winkler and Meinolf Siepermann and Roland Meisel and Schlegel, {Paul G} and J{\"u}rgen Hess and Horst Lindhofer and Arndt Borkhardt and Raymund Buhmann",
note = "{\textcopyright} 2014 John Wiley & Sons Ltd.",
year = "2015",
month = apr,
doi = "10.1111/bjh.13242",
language = "English",
volume = "169",
pages = "90--102",
journal = "BRIT J HAEMATOL",
issn = "0007-1048",
publisher = "Wiley-Blackwell",
number = "1",

}

RIS

TY - JOUR

T1 - Immunotherapy with the trifunctional anti-CD20 x anti-CD3 antibody FBTA05 (Lymphomun) in paediatric high-risk patients with recurrent CD20-positive B cell malignancies

AU - Schuster, Friedhelm R

AU - Stanglmaier, Michael

AU - Woessmann, Wilhelm

AU - Winkler, Beate

AU - Siepermann, Meinolf

AU - Meisel, Roland

AU - Schlegel, Paul G

AU - Hess, Jürgen

AU - Lindhofer, Horst

AU - Borkhardt, Arndt

AU - Buhmann, Raymund

N1 - © 2014 John Wiley & Sons Ltd.

PY - 2015/4

Y1 - 2015/4

N2 - Children with B cell malignancies refractory to standard therapy are known to have a poor prognosis and very limited treatment options. Here, we report on the treatment and follow-up of ten patients diagnosed with relapsed or refractory mature B-cell Non Hodgkin Lymphoma (B-NHL), Burkitt leukaemia (B-AL) or pre B-acute lymphoblastic leukaemia (pre B-ALL). All children were treated with FBTA05 (now designated Lymphomun), an anti-CD3 x anti-CD20 trifunctional bispecific antibody (trAb) in compassionate use. Within individual treatment schedules, Lymphomun was applied (a) after allogeneic stem cell transplantation (allo-SCT, n = 6) to induce sustained long-term remission, or (b) stand alone prior to subsequent chemotherapy to eradicate residual disease before allo-SCT (n = 4). Nine of ten children displayed a clinical response: three stable diseases (SD), one partial remission (PR) and five induced or sustained complete remissions (CR). Five of these nine responders died during follow-up. The other patients still maintain CR with a current overall survival of 874-1424 days (median: 1150 days). In conclusion, despite the dismal clinical prognosis of children refractory to standard therapy, immunotherapy with Lymphomun resulted in a favourable clinical outcome in this cohort of refractory paediatric patients.

AB - Children with B cell malignancies refractory to standard therapy are known to have a poor prognosis and very limited treatment options. Here, we report on the treatment and follow-up of ten patients diagnosed with relapsed or refractory mature B-cell Non Hodgkin Lymphoma (B-NHL), Burkitt leukaemia (B-AL) or pre B-acute lymphoblastic leukaemia (pre B-ALL). All children were treated with FBTA05 (now designated Lymphomun), an anti-CD3 x anti-CD20 trifunctional bispecific antibody (trAb) in compassionate use. Within individual treatment schedules, Lymphomun was applied (a) after allogeneic stem cell transplantation (allo-SCT, n = 6) to induce sustained long-term remission, or (b) stand alone prior to subsequent chemotherapy to eradicate residual disease before allo-SCT (n = 4). Nine of ten children displayed a clinical response: three stable diseases (SD), one partial remission (PR) and five induced or sustained complete remissions (CR). Five of these nine responders died during follow-up. The other patients still maintain CR with a current overall survival of 874-1424 days (median: 1150 days). In conclusion, despite the dismal clinical prognosis of children refractory to standard therapy, immunotherapy with Lymphomun resulted in a favourable clinical outcome in this cohort of refractory paediatric patients.

KW - Adolescent

KW - Allografts

KW - Antibodies, Bispecific/administration & dosage

KW - Burkitt Lymphoma/mortality

KW - Child

KW - Child, Preschool

KW - Disease-Free Survival

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Immunotherapy

KW - Male

KW - Neoplasm, Residual

KW - Precursor B-Cell Lymphoblastic Leukemia-Lymphoma/mortality

KW - Stem Cell Transplantation

KW - Survival Rate

U2 - 10.1111/bjh.13242

DO - 10.1111/bjh.13242

M3 - SCORING: Journal article

C2 - 25495919

VL - 169

SP - 90

EP - 102

JO - BRIT J HAEMATOL

JF - BRIT J HAEMATOL

SN - 0007-1048

IS - 1

ER -