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Modified risk-stratified sequential treatment (subcutaneous rituximab with or without chemotherapy) in B-cell Post-transplant lymphoproliferative disorder (PTLD) after Solid organ transplantation (SOT): the prospective multicentre phase II PTLD-2 trial
by
Dreyling, Martin H
, Zimmermann, Heiner
, Anagnostopoulos, Ioannis
, Trappe, Ralf U
, Siebert, Reiner
, Heuser, Michael
, Rummel, Mathias J
, Koenecke, Christian
, Schmidt, Christian
, Schlattmann, Peter
, Hauser, Ingeborg A
, Oschlies, Ilske
, Wolf, Dominik
, Dührsen, Ulrich
, Hahn, Dennis
, Ritgen, Matthias
, Pott, Christiane
, Meidenbauer, Norbert
in
CD20 antigen
/ Chemotherapy
/ Clinical trials
/ Immunotherapy
/ Lymphatic diseases
/ Lymphocytes
/ Lymphocytes B
/ Monoclonal antibodies
/ Patients
/ Posttransplant lymphoproliferative disorders
/ Remission
/ Risk
/ Risk groups
/ Rituximab
/ Survival
/ Thorax
/ Transplantation
/ Transplants & implants
2022
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Modified risk-stratified sequential treatment (subcutaneous rituximab with or without chemotherapy) in B-cell Post-transplant lymphoproliferative disorder (PTLD) after Solid organ transplantation (SOT): the prospective multicentre phase II PTLD-2 trial
by
Dreyling, Martin H
, Zimmermann, Heiner
, Anagnostopoulos, Ioannis
, Trappe, Ralf U
, Siebert, Reiner
, Heuser, Michael
, Rummel, Mathias J
, Koenecke, Christian
, Schmidt, Christian
, Schlattmann, Peter
, Hauser, Ingeborg A
, Oschlies, Ilske
, Wolf, Dominik
, Dührsen, Ulrich
, Hahn, Dennis
, Ritgen, Matthias
, Pott, Christiane
, Meidenbauer, Norbert
in
CD20 antigen
/ Chemotherapy
/ Clinical trials
/ Immunotherapy
/ Lymphatic diseases
/ Lymphocytes
/ Lymphocytes B
/ Monoclonal antibodies
/ Patients
/ Posttransplant lymphoproliferative disorders
/ Remission
/ Risk
/ Risk groups
/ Rituximab
/ Survival
/ Thorax
/ Transplantation
/ Transplants & implants
2022
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Modified risk-stratified sequential treatment (subcutaneous rituximab with or without chemotherapy) in B-cell Post-transplant lymphoproliferative disorder (PTLD) after Solid organ transplantation (SOT): the prospective multicentre phase II PTLD-2 trial
by
Dreyling, Martin H
, Zimmermann, Heiner
, Anagnostopoulos, Ioannis
, Trappe, Ralf U
, Siebert, Reiner
, Heuser, Michael
, Rummel, Mathias J
, Koenecke, Christian
, Schmidt, Christian
, Schlattmann, Peter
, Hauser, Ingeborg A
, Oschlies, Ilske
, Wolf, Dominik
, Dührsen, Ulrich
, Hahn, Dennis
, Ritgen, Matthias
, Pott, Christiane
, Meidenbauer, Norbert
in
CD20 antigen
/ Chemotherapy
/ Clinical trials
/ Immunotherapy
/ Lymphatic diseases
/ Lymphocytes
/ Lymphocytes B
/ Monoclonal antibodies
/ Patients
/ Posttransplant lymphoproliferative disorders
/ Remission
/ Risk
/ Risk groups
/ Rituximab
/ Survival
/ Thorax
/ Transplantation
/ Transplants & implants
2022
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Modified risk-stratified sequential treatment (subcutaneous rituximab with or without chemotherapy) in B-cell Post-transplant lymphoproliferative disorder (PTLD) after Solid organ transplantation (SOT): the prospective multicentre phase II PTLD-2 trial
Journal Article
Modified risk-stratified sequential treatment (subcutaneous rituximab with or without chemotherapy) in B-cell Post-transplant lymphoproliferative disorder (PTLD) after Solid organ transplantation (SOT): the prospective multicentre phase II PTLD-2 trial
2022
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Overview
The prospective multicentre Phase II PTLD-2 trial (NCT02042391) tested modified risk-stratification in adult SOT recipients with CD20-positive PTLD based on principles established in the PTLD-1 trials: sequential treatment and risk-stratification. After rituximab monotherapy induction, patients in complete remission as well as those in partial remission with IPI < 3 at diagnosis (low-risk) continued with rituximab monotherapy and thus chemotherapy free. Most others (high-risk) received R-CHOP-21. Thoracic SOT recipients who progressed (very-high-risk) received alternating R-CHOP-21 and modified R-DHAOx. The primary endpoint was event-free survival (EFS) in the low-risk group. The PTLD-1 trials provided historical controls. Rituximab was applied subcutaneously. Of 60 patients enrolled, 21 were low-risk, 28 high-risk and 9 very-high-risk. Overall response was 45/48 (94%, 95% CI 83–98). 2-year Kaplan–Meier estimates of time to progression and overall survival were 78% (95% CI 65–90) and 68% (95% CI 55–80) – similar to the PTLD-1 trials. Treatment-related mortality was 4/59 (7%, 95% CI 2–17). In the low-risk group, 2-year EFS was 66% (95% CI 45–86) versus 52% in the historical comparator that received CHOP (p = 0.432). 2-year OS in the low-risk group was 100%. Results with R-CHOP-21 in high-risk patients confirmed previous results. Immunochemotherapy intensification in very-high-risk patients was disappointing.
Publisher
Nature Publishing Group
Subject
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