LLPC working group

 

Composition 

Chair

Prof. M.J. Kersten (AmsterdamUMC – AMC, Amsterdam)

Vice-Chair

Dr. P Mutsaers (ErasmusMC, Rotterdam)

Secretary

Dr. M.W.M. van der Poel (MUMC, Maastricht)


Key objectives of working group

The key objectives of this working group are:

  • To contribute actively to the implementation of so-called “first-in-man” phase I-II studies in malignant diseases of the blood, bone marrow and lymph nodes, including, but not limited to Non-Hodgkin's lymphoma (B and T cell), Hodgkin's lymphoma and chronic lymphocytic leukemia (CLL). Promising new drugs can then be incorporated in phase III studies, which are executed by the HOVON Lymphoma and CLL Working Groups. This creates the perspective to operate in the front line in HOVON with regard to the treatment of lymphomas and CLL with innovative therapies.
  • By close collaboration, the turnaround time for deciding on studies, getting the protocol approved and enrolling the first patients is short.
  • For the time being, it is expected that trials performed in the context of HOVON/LLPC will mainly be industry-sponsored trials. Ultimately, the goal is also to develop investigator-initiated studies. The working group will assess the relevance and feasibility of each study offered through one of its members or by industry. If it is decided to participate in the study on behalf of HOVON/LLPC, it will be determined by mutual agreement how many and which centers will participate, making sure there is regional spread. Non-participating centers are committed to refer patients to participating centers for study opportunities.

The Lunenburg Lymphoma Phase 1 / II Consortium (LLPC) was founded in 2009 by 5 departments of Hematology of Dutch (academic) hospitals. Currently, the participating hospitals are:

  • AmsterdamUMC, locations AMC and VUMC, Amsterdam
  • Erasmus Medical Center (Erasmus MC), Rotterdam
  • University Medical Center Groningen (UMCG), Groningen
  • Radboud University Medical Center (RadboudUMC), Nijmegen
  • University Medical Center Utrecht (UMCU), Utrecht
  • Leiden University Medical Center (LUMC), Leiden
  • Maastricht University Medical Center (MUMC), Maastricht

Other centers can join the consortium if they are interested in and have the required facilities/dedicated study personnel to perform phase I/II studies.


Publication overview

Bi-specific antibodies

Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell–Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial
Catherine Thieblemont, MD, PhD; Tycel Phillips, MD; Herve Ghesquieres, MD, PhD; Chan Y. Cheah, MBBS, DMSc; Michael Roost Clausen, MD, PhD; David Cunningham, MD; Young Rok Do, MD, PhD; Tatyana Feldman, MD; Robin Gasiorowski, MBBS, PhD; Wojciech Jurczak, MD, PhD; Tae Min Kim, MD, PhD; David John Lewis, MD; Marjolein van der Poel, MD, PhD; Michelle Limei Poon, MD; Mariana Cota Stirner, MD, PhD; Nurgul Kilavuz, MSc;
Christopher Chiu, PhD; Menghui Chen, PhD; Mariana Sacchi, MD; Brian Elliott, MD; Tahamtan Ahmadi, MD, PhD; Martin Hutchings, MD, PhD; and Pieternella J. Lugtenburg, MD, PhD. JCO 2022

Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study
Martin Hutchings, Rogier Mous, Michael Roost Clausen, Peter Johnson, Kim M Linton, Martine E D Chamuleau, David John Lewis,Anna Sureda Balari, David Cunningham, Roberto S Oliveri, Brian Elliott, Dena DeMarco, Ada Azaryan, Christopher Chiu, Tommy Li, Kuo-mei Chen, Tahamtan Ahmadi, Pieternella J Lugtenburg. The Lancet. 2019

CAR T-cell

Safety and Efficacy of Axicabtagene Ciloleucel versus Standard of Care in Patients 65 Years of Age or Older with Relapsed/Refractory Large B-Cell Lymphoma
Jason R Westin, Frederick L Locke, Michael Dickinson, Armin Ghobadi, Mahmoud Elsawy, Tom van Meerten, David B Miklos, Matthew L Ulrickson, Miguel-Angel Perales, Umar Farooq, Luciano Wannesson, Lori Leslie, Marie José Kersten, Caron A Jacobson, John M Pagel, Gerald Wulf, Patrick Johnston, Aaron P Rapoport, Linqiu Du, Saran Vardhanabhuti, Simone Filosto, Jina Shah, Julia T Snider, Paul Cheng, Christina To, Olalekan O Oluwole, Anna Sureda; Clin Cancer Res. 2023

Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial.
Kamdar M, Solomon SR, Arnason J, Johnston PB, Glass B, Bachanova V, Ibrahimi S, Mielke S, Mutsaers P, Hernandez-Ilizaliturri F, Izutsu K, Morschhauser F, Lunning M, Maloney DG, Crotta A, Montheard S, Previtali A, Stepan L, Ogasawara K, Mack T, Abramson JS; Lancet. 2022

Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma
Michael R. Bishop, M.D., Michael Dickinson, M.B., B.S., D.M.Sci., Duncan Purtill, M.D., M.B., B.S., Pere Barba, M.D., Ph.D., Armando Santoro, M.D., Nada Hamad, M.B., B.S., Koji Kato, M.D., Ph.D., Anna Sureda, M.D., Ph.D., Richard Greil, M.D., Catherine Thieblemont, M.D., Ph.D., Franck Morschhauser, M.D., Ph.D., Martin Janz, M.D., Ian Flinn, M.D., Werner Rabitsch, M.D., Yok-Lam Kwong, M.D., Marie J. Kersten, M.D., Ph.D., Monique C. Minnema, M.D., Ph.D., Harald Holte, M.D., Ph.D., Esther H.L. Chan, M.B., B.S., Joaquin Martinez-Lopez, M.D., Ph.D., Antonia M.S. Müller, P.D.Dr.Med., Richard T. Maziarz, M.D., Joseph P. McGuirk, D.O., Emmanuel Bachy, M.D., Ph.D., Steven Le Gouill, M.D., Ph.D., Martin Dreyling, M.D., Hideo Harigae, M.D., Ph.D., David Bond, M.D., Charalambos Andreadis, M.D., M.S.C.E., Peter McSweeney, M.D., M.B., Ch.B., Mohamed Kharfan-Dabaja, M.D., Simon Newsome, Ph.D., Evgeny Degtyarev, M.Sc., Rakesh Awasthi, Ph.D., Christopher del Corral, Pharm.D., Giovanna Andreola, M.D., Aisha Masood, M.D., Stephen J. Schuster, M.D., Ulrich Jäger, M.D., Peter Borchmann, M.D., and Jason R. Westin, M.D. NEJM. 2022

KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma
M. Wang, J. Munoz, A. Goy, F.L. Locke, C.A. Jacobson, B.T. Hill,J.M. Timmerman, H. Holmes, S. Jaglowski, I.W. Flinn, P.A. McSweeney,D.B. Miklos, J.M. Pagel, M.-J. Kersten, N. Milpied, H. Fung, M.S. Topp,R. Houot, A. Beitinjaneh, W. Peng, L. Zheng, J.M. Rossi, R.K. Jain, A.V. Rao, and P.M. Reagan. N Engl J Med. 2020

Tisagenlecleucel cellular kinetics, dose, and immunogenicity in relation to clinical factors in relapsed/refractory DLBCL
Rakesh Awasthi, Lida Pacaud, Edward Waldron, Constantine S. Tam, Ulrich Jager,  Peter Borchmann, Samantha Jaglowski, Stephen Ronan Foley, Koen van Besien, Nina D. Wagner-Johnston, Marie Jose Kersten, Stephen J. Schuster, Gilles Salles, Richard T. Maziarz, Ozlem Anak,Christopher del Corral, Jufen Chu, Irina Gershgorin, Iulian Pruteanu-Malinici Abhijit Chakraborty,Karen Thudium Mueller,and Edmund K. Waller. Blood Advances. 2020

Kinase inhibitors and anti-apoptosis inhibitors

Durable response with single-agent acalabrutinib in patients with relapsed or refractory mantle cell lymphoma
Michael Wang,  Simon Rule, Pier Luigi Zinzani,  Andre Goy, Olivier Casasnovas, Stephen D. Smith Gandhi Damaj, Jeanette K. Doorduijn, Thierry Lamy, Franck Morschhauser, Carlos Panizo, Bijal Shah, Andrew Davies, Richard Eek, Jehan Dupuis, Eric Jacobsen, Arnon P. Kater, Steven Le Gouill, Lucie Oberic, Tadeusz Robak, Preetesh Jain, Melanie M. Frigault, Raquel Izumi, Dorothy Nguyen, Priti Patel , Ming Yin, Monika Długosz-Danecka. Leukemia. 2019

A phase II study of venetoclax plus R-CHOP as first-line treatment for patients with diffuse large B-cell lymphoma
Franck Morschhauser, Pierre Feugier, Ian W. Flinn, Robin Gasiorowski, Richard Greil, Arp ´ ad Ill ´ es,  Nathalie A. Johnson, Jean-François Larouche, Pieternella J. Lugtenburg, Caterina Patti, Gilles A. Salles, Marek Trnenˇ y, Sven de Vos, Farheen Mir,Divya Samineni, Su Y. Kim, Yanwen Jiang, Elizabeth Punnoose, Arijit Sinha, Emma Clark, Nathalie Spielewoy, Kathryn Humphrey, Alexandra Bazeos, and Andrew D. Zelenetz. Blood. 2021

Durable response with single-agent acalabrutinib in patients with relapsed or refractory mantle cell lymphoma.
Michael Wang,  Simon Rule , Pier Luigi Zinzani,  Andre Goy,  Olivier Casasnovas, Stephen D. Smith, Gandhi Damaj,  Jeanette K. Doorduijn,  Thierry Lamy,  Franck Morschhauser, Carlos Panizo, Bijal Shah, Andrew Davies,  Richard Eek ,  Jehan Dupuis,  Eric Jacobsen,  Arnon P. Kater,  Steven Le Gouill, Lucie Oberic,  Tadeusz Robak,  Preetesh Jain, Melanie M. Frigault, Raquel Izumi,  Dorothy Nguyen, Priti Patel,  Ming Yin,  Monika Długosz-Danecka. Leukemia. 2019

Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. 
Michael Wang, Simon Rule, Pier Luigi Zinzani, Andre Goy, Olivier Casasnovas, Stephen D Smith, Gandhi Damaj, Jeanette Doorduijn, Thierry Lamy, Franck Morschhauser, Carlos Panizo , Bijal Shah, Andrew Davies, Richard Eek, Jehan Dupuis, Eric Jacobsen , Arnon P Kater, Steven Le Gouill, Lucie Oberic, Taduesz Robak , Todd Covey, Richa Dua, Ahmed Hamdy, Xin Huang, Raquel Izumi, Priti Patel, Wayne Rothbaum, J Greg Slatter, Wojciech Jurczak. Lancet. 2018

Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial.
Andrew D Zelenetz, Gilles Salles, Kylie D Mason, Carla Casulo, Steven Le Gouill , Laurie H Sehn, Herve Tilly, Guillaume Cartron, Martine E D Chamuleau, Andre Goy, Constantine S Tam, Pieternella J Lugtenburg, Adam M Petrich, Arijit Sinha, Divya Samineni, Sylvia Herter, Ellen Ingalla, Edith Szafer-Glusman, Christian Klein, Deepak Sampath, Martin Kornacker, Mehrdad Mobasher, Franck Morschhauser. Blood. 2019

Final results of a phase 1b study of the safety and efficacy of the PI3Kδ inhibitor acalisib (GS-9820) in relapsed/refractory lymphoid malignancies.
Arnon P Kater, Sanne H Tonino, Marjolein Spiering, Martine E D Chamuleau, Roberto Liu, Adeboye Henry Adewoye, Jie Gao, Lyndah Dreiling, Yan Xin, Jeanette K Doorduijn, Marie José Kersten, HOVON Lunenburg Lymphoma Phase I/II Consortium. Blood Cancer Journal. 2018

Antibodies and antibody-drug conjugates

Combining brentuximab vedotin with dexamethasone, high-dose cytarabine and cisplatin as salvage treatment in relapsed or refractory Hodgkin lymphoma: the phase II HOVON/LLPC Transplant BRaVE study
Marie José Kersten, Julia Driessen, Josée M. Zijlstra,Wouter J. Plattel, Franck Morschhauser, Pieternella J. Lugtenburg, Pauline Brice, Martin Hutchings, Thomas Gastinne, Roberto Liu,Coreline N. Burggraaff, Marcel Nijland, Sanne H. Tonino, Anne I.J. Arens, Roelf Valkema,Harm van Tinteren, Marta Lopez-Yurda, Arjan Diepstra, Daphne De Jong2, and Anton Hagenbeek. Haematology. 2019

Avadomide plus obinutuzumab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (CC-122-NHL-001): a multicentre, dose escalation and expansion phase 1 study
Jean-Marie Michot, Reda Bouabdallah, Umberto Vitolo, Jeanette K Doorduijn*, Gilles Salles, Annalisa Chiappella, Pier Luigi Zinzani, Fontanet Bijou, Marie José Kersten*, Rafael Sarmiento, Silvia Mosulen, Cristina Mendez, Shailaja Uttamsingh, Michael Pourdehnad, Kristen Hege, Tianlei Chen, Klein, Patrick R Hagner, Zariana Nikolova, Vincent Ribrag. Lancet Haematol. 2020

Phase I dose-escalation study of brentuximab-vedotin combined with dexamethasone, high-dose cytarabine and cisplatin, as salvage treatment in relapsed/refractory classical Hodgkin lymphoma: The HOVON/LLPC Transplant BRaVE study.
Anton Hagenbeek, Hans Mooij , Josée Zijlstra, Pieternella Lugtenburg, Gustaaf van Imhoff, Marcel Nijland, Sanne Tonino, Martin Hutchings, Marjolein Spiering, Roberto Liu, Harm van Tinteren, Marie José Kersten. Haematologica. 2018

Phase 2 Study of Daratumumab in Relapsed/Refractory Mantle-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma.
Gilles Salles, Ajay K Gopal, Monique C Minnema, Karen Wakamiya, Huaibao Feng, Jordan M Schecter, Michael Wang. Clinical Lymphoma, Myeloma & Leukemia. 2018

European phase II study of mogamulizumab, an anti-CCR4 monoclonal antibody, in relapsed/refractory peripheral T-cell lymphoma.
Pier Luigi Zinzani , Lionel Karlin, John Radford, Dolores Caballero, Paul Fields, Martine E D Chamuleau, Francesco d'Amore, Corinne Haioun, Catherine Thieblemont, Eva González-Barca, Carlos Grande García, Peter W Johnson, Gustaaf W van Imhoff, Thomas Ng, Karen Dwyer, Franck Morschhauser. Haematologica. 2016

Checkpoint inhibitors

A phase 1/2, open-label, multicenter study of isatuximab in combination with cemiplimab in patients with lymphoma
Carmelo Carlo-Stella, Pier Luigi Luigi Zinzani, Anna Sureda, Luís Francisco Araújo, Olivier Casasnovas, Cecilia Carpio, Su-Peng Yeh, Krimo Bouabdallah, Guillaume Cartron, Won Seog Kim, Raul Cordoba, Youngil Koh, Alessandro Re, Daniela Alves, Martine E.D Chamuleau, Steven Le Gouill, Armando Lopez-Guillermo, Maria Ilidia Moreira, Marjolein W.M. Van Der Poel, Giovanni Abbadessa, Robin Meng, Ran Ji, Lucie Lepine, Rao Saleem, Vincent Ribrag. Blood 2021

Nivolumab for Relapsed/Refractory Classic Hodgkin Lymphoma After Failure of Autologous Hematopoietic Cell Transplantation: Extended Follow-Up of the Multicohort Single-Arm Phase II CheckMate 205 Trial.
Philippe Armand, Andreas Engert, Anas Younes, Michelle Fanale, Armando Santoro, Pier Luigi Zinzani, John M Timmerman, Graham P Collins, Radhakrishnan Ramchandren, Jonathon B Cohen, Jan Paul De Boer, John Kuruvilla, Kerry J Savage, Marek Trneny, Margaret A Shipp, Kazunobu Kato, Anne Sumbul, Benedetto Farsaci, Stephen M Ansell. J Clin Oncol. 2018

Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study.
Stephen M Ansell, Monique C Minnema, Peter Johnson, John M Timmerman, Philippe Armand, Margaret A Shipp, Scott J Rodig, Azra H Ligon, Margaretha G M Roemer, Nishitha Reddy, Jonathon B Cohen, Sarit Assouline, Michelle Poon, Manish Sharma, Kazunobu Kato, Selda Samakoglu, Anne Sumbul, Andrew Grigg. J Clin Oncol. 2019


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