European Medicines Agency - Regulatory - Regulation of medicines

3 - Specific competencies and capacity to provide export advice

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ITCC - Innovative Therapies for Children and Adolescents with Cancer
Number of peer reviewed publications in the last 5 years 15 Inotuzumab ozogamicin combined with chemotherapy in pediatric B-cell precursor CD22+ acute lymphoblastic leukemia: results of the phase IB ITCC-059 trial Edoardo Pennesi, Erica Brivio, Anneke C. J. Ammerlaan, Yilin Jiang, Vincent H. J. van der Velden, H. Berna Beverloo, Barbara Sleight, Franco Locatelli, Benoit Brethon, Claudia Rossig, Gernot Engstler, Anna Nilsson, Benedicte Bruno, Arnaud Petit, Bella Bielorai, Carmelo Rizzari, Fanny Rialland, Alba Rubio-San-Simón, Francisco J. Bautista Sirvent, Cristina Diaz-de-Heredia, Susana Rives, Christian M. Zwaan Haematologica. 2024 Oct 1; 109(10): 3157–3166. Published online 2024 Oct 4. doi: 10.3324/haematol.2023.284409 PMCID: PMC11443403 AbstractArticlePDF–2.2M Population Pharmacokinetics of Inotuzumab Ozogamicin in Pediatric Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia: Results of Study ITCC-059 Jen-Hao Wu, Edoardo Pennesi, Francisco Bautista, May Garrett, Kei Fukuhara, Erica Brivio, Anneke C. J. Ammerlaan, Franco Locatelli, Inge M. van der Sluis, Claudia Rossig, Christiane Chen-Santel, Bella Bielorai, Arnaud Petit, Jan Starý, Cristina Díaz-de-Heredia, Susana Rives, Aengus O’Marcaigh, Carmelo Rizzari, Gernot Engstler, Karsten Nysom, Alba Rubio-San-Simón, Benedicte Bruno, Yves Bertrand, Benoît Brethon, Fanny Rialland, Geneviève Plat, Uta Dirksen, Lucie Sramkova, C. Michel Zwaan, Alwin D. R. Huitema Clin Pharmacokinet. 2024; 63(7): 981–997. Published online 2024 Jun 22. doi: 10.1007/s40262-024-01386-z PMCID: PMC11271359 AbstractArticlePDF–2.0M Frontline and Relapsed Rhabdomyosarcoma (FaR-RMS) Clinical Trial: A Report from the European Paediatric Soft Tissue Sarcoma Study Group (EpSSG) Julia Chisholm, Henry Mandeville, Madeleine Adams, Veronique Minard-Collin, Timothy Rogers, Anna Kelsey, Janet Shipley, Rick R. van Rijn, Isabelle de Vries, Roelof van Ewijk, Bart de Keizer, Susanne A. Gatz, Michela Casanova, Lisa Lyngsie Hjalgrim, Charlotte Firth, Keith Wheatley, Pamela Kearns, Wenyu Liu, Amanda Kirkham, Helen Rees, Gianni Bisogno, Ajla Wasti, Sara Wakeling, Delphine Heenen, Deborah A. Tweddle, Johannes H. M. Merks, Meriel Jenney Cancers (Basel) 2024 Mar; 16(5): 998. Published online 2024 Feb 29. doi: 10.3390/cancers16050998 Correction in: Cancers (Basel). 2024 Oct; 16(19): 3427. PMCID: PMC10931395 AbstractArticlePDF–1.2M The PedAL/EuPAL Project: A Global Initiative to Address the Unmet Medical Needs of Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia Valeria Ceolin, Sae Ishimaru, Seth E. Karol, Francisco Bautista, Bianca Frederika Goemans, Gwenaëlle Gueguen, Marieke Willemse, Laura Di Laurenzio, Jennifer Lukin, Harm van Tinteren, Franco Locatelli, Arnaud Petit, Daisuke Tomizawa, Alice Norton, Gertjan Kaspers, Dirk Reinhardt, Sarah K. Tasian, Gwen Nichols, Edward Anders Kolb, Christian Michel Zwaan, Todd Michael Cooper Cancers (Basel) 2024 Jan; 16(1): 78. Published online 2023 Dec 22. doi: 10.3390/cancers16010078 PMCID: PMC10778551 AbstractArticlePDF–784K Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921 Erica Brivio, Edoardo Pennesi, Marieke E. Willemse, Alwin D.R. Huitema, Yilin Jiang, Harm D.R. van Tinteren, Vincent H.J. van der Velden, Berna H. Beverloo, Monique L. den Boer, Lukas A.J. Rammeloo, Chad Hudson, Nyla Heerema, Karey Kowalski, Huadong Zhao, Luke Kuttschreuter, Francisco J. Bautista Sirvent, Andrew Bukowinski, Carmelo Rizzari, Jessica Pollard, Laura Murillo-Sanjuán, Matthew Kutny, Sara Zarnegar-Lumley, Michele Redell, Stacy Cooper, Yves Bertrand, Arnaud Petit, Julie Krystal, Markus Metzler, Donna Lancaster, Jean-Pierre Bourquin, Jayashree Motwani, Inge M. van der Sluis, Franco Locatelli, Michael E. Roth, Nobuko Hijiya, Christian M. Zwaan J Clin Oncol. 2024 Mar 1; 42(7): 821–831. Published online 2023 Nov 30. doi: 10.1200/JCO.23.00897 PMCID: PMC10906575 AbstractArticlePDF–1.2M Evaluating preclinical evidence for clinical translation in childhood brain tumours: Guidelines from the CONNECT, PNOC, and ITCC brain networks Chris Jones, Karin Straathof, Maryam Fouladi, Darren Hargrave, Michael Prados, Adam Resnick, Francois Doz, David T.W. Jones, Sabine Mueller Front Oncol. 2023; 13: 1167082. Published online 2023 Apr 5. doi: 10.3389/fonc.2023.1167082 PMCID: PMC10114612 AbstractArticlePDF–956K Combination Early-Phase Trials of Anticancer Agents in Children and Adolescents Lucas Moreno, Steven G. DuBois, Julia Glade Bender, Audrey Mauguen, Nick Bird, Vickie Buenger, Michela Casanova, François Doz, Elizabeth Fox, Lia Gore, Douglas S. Hawkins, Shai Izraeli, David T.W. Jones, Pamela R. Kearns, Jan J. Molenaar, Karsten Nysom, Stefan Pfister, Gregory Reaman, Malcolm Smith, Brenda Weigel, Gilles Vassal, Christian Michel Zwaan, Xavier Paoletti, Alexia Iasonos, Andrew D.J. Pearson J Clin Oncol. 2023 Jun 20; 41(18): 3408–3422. Published online 2023 Apr 4. doi: 10.1200/JCO.22.02430 PMCID: PMC10414747 AbstractArticlePDF–342K Cobimetinib in Pediatric and Young Adult Patients with Relapsed or Refractory Solid Tumors (iMATRIX-cobi): A Multicenter, Phase I/II Study Tanya Trippett, Helen Toledano, Quentin Campbell Hewson, Arnauld Verschuur, Anne-Marie Langevin, Isabelle Aerts, Lisa Howell, Soledad Gallego, Claudia Rossig, Amy Smith, Darshak Patel, Leonardo R. Pereira, Sravanthi Cheeti, Luna Musib, Katherine E. Hutchinson, Clare Devlin, Ronald Bernardi, Birgit Geoerger Target Oncol. 2022; 17(3): 283–293. Published online 2022 Jun 17. doi: 10.1007/s11523-022-00888-9 PMCID: PMC9217999 AbstractArticlePDF–648K Inotuzumab ozogamicin as single agent in pediatric patients with relapsed and refractory acute lymphoblastic leukemia: results from a phase II trial Edoardo Pennesi, Naomi Michels, Erica Brivio, Vincent H. J. van der Velden, Yilin Jiang, Adriana Thano, Anneke J. C. Ammerlaan, Judith M. Boer, H. Berna Beverloo, Barbara Sleight, Ying Chen, Britta Vormoor-Bürger, Susana Rives, Bella Bielorai, Claudia Rössig, Arnaud Petit, Carmelo Rizzari, Gernot Engstler, Jan Starý, Francisco J. Bautista Sirvent, Christiane Chen-Santel, Benedicte Bruno, Yves Bertrand, Fanny Rialland, Geneviève Plat, Dirk Reinhardt, Luciana Vinti, Arend Von Stackelberg, Franco Locatelli, Christian M. Zwaan Leukemia. 2022; 36(6): 1516–1524. Published online 2022 Apr 25. doi: 10.1038/s41375-022-01576-3 PMCID: PMC9162924 AbstractArticlePDF–803K Selumetinib in combination with dexamethasone for the treatment of relapsed/refractory RAS-pathway mutated paediatric and adult acute lymphoblastic leukaemia (SeluDex): study protocol for an international, parallel-group, dose-finding with expansion phase I/II trial Tobias Menne, Daniel Slade, Joshua Savage, Sarah Johnson, Julie Irving, Pamela Kearns, Ruth Plummer, Geoff Shenton, Gareth J Veal, Britta Vormoor, Josef Vormoor, Lucinda Billingham BMJ Open. 2022; 12(3): e059872. Published online 2022 Mar 4. doi: 10.1136/bmjopen-2021-059872 PMCID: PMC8900053 AbstractArticlePDF–607K Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050)☆ N. Gaspar, Q. Campbell-Hewson, S. Gallego Melcon, F. Locatelli, R. Venkatramani, S. Hecker-Nolting, M. Gambart, F. Bautista, E. Thebaud, I. Aerts, B. Morland, C. Rossig, A. Canete Nieto, A. Longhi, C. Lervat, N. Entz-Werle, S.J. Strauss, P. Marec-Berard, C.E. Okpara, C. He, L. Dutta, M. Casanova ESMO Open. 2021 Oct; 6(5): 100250. Published online 2021 Sep 22. doi: 10.1016/j.esmoop.2021.100250 PMCID: PMC8477142 AbstractArticlePDF–451K A phase 1 study of inotuzumab ozogamicin in pediatric relapsed/refractory acute lymphoblastic leukemia (ITCC-059 study) Erica Brivio, Franco Locatelli, Marta Lopez-Yurda, Andrea Malone, Cristina Díaz-de-Heredia, Bella Bielorai, Claudia Rossig, Vincent H. J. van der Velden, Anneke C. J. Ammerlaan, Adriana Thano, Inge M. van der Sluis, Monique L. den Boer, Ying Chen, Barbara Sleight, Benoit Brethon, Karsten Nysom, Lucie Sramkova, Ingrid Øra, Luciana Vinti, Christiane Chen-Santel, Christian Michel Zwaan Blood. 2021 Mar 25; 137(12): 1582–1590. Prepublished online 2020 Oct 16. doi: 10.1182/blood.2020007848 PMCID: PMC7995290 AbstractArticle Impact of COVID-19 in paediatric early-phase cancer clinical trials in Europe: A report from the Innovative Therapies for Children with Cancer (ITCC) consortium Alba Rubio-San-Simón, Nicolas André, Maria Giuseppina Cefalo, Isabelle Aerts, Alicia Castañeda, Sarah Benezech, Guy Makin, Natasha van Eijkelenburg, Karsten Nysom, Lynley Marshall, Marion Gambart, Raquel Hladun, Claudia Rossig, Luca Bergamaschi, Franca Fagioli, Ben Carpenter, Stephane Ducassou, Cormac Owens, Ingrid Øra, Antonio Juan Ribelles, Bram De Wilde, Pilar Guerra-García, Marion Strullu, Carmelo Rizzari, Torben Ek, Simone Hettmer, Nicolas U. Gerber, Christine Rawlings, Manuel Diezi, Sauli Palmu, Antonio Ruggiero, Jaime Verdú, Teresa de Rojas, Gilles Vassal, Birgit Geoerger, Lucas Moreno, Francisco Bautista Eur J Cancer. 2020 Dec; 141: 82–91. Published online 2020 Oct 9. doi: 10.1016/j.ejca.2020.09.024 PMCID: PMC7546235 AbstractArticlePDF–558K Paediatric Strategy Forum for medicinal product development for acute myeloid leukaemia in children and adolescents Andrew. D.J. Pearson, C.Michel Zwaan, E.Anders Kolb, Dominik Karres, Julie Guillot, Su Young Kim, Lynley Marshall, Sarah K. Tasian, Malcolm Smith, Todd Cooper, Peter C. Adamson, Elly Barry, Bouchra Benettaib, Florence Binlich, Anne Borgman, Erica Brivio, Renaud Capdeville, David Delgado, Douglas V. Faller, Linda Fogelstrand, Paula Goodman Fraenkel, Henrik Hasle, Delphine Heenen, Gertjan Kaspers, Mark Kieran, Jan-Henning Klusmann, Giovanni Lesa, Franca Ligas, Silvia Mappa, Hesham Mohamed, Andrew Moore, Joan Morris, Kerri Nottage, Dirk Reinhardt, Nicole Scobie, Stephen Simko, Thomas Winkler, Koen Norga, Gregory Reaman, Gilles Vassal Eur J Cancer. Author manuscript; available in PMC 2021 Jan 7. Published in final edited form as: Eur J Cancer. 2020 Sep; 136: 116–129. Published online 2020 Jul 17. doi: 10.1016/j.ejca.2020.04.038 PMCID: PMC7789799 AbstractArticlePDF–372K INFORM2 NivEnt: The first trial of the INFORM2 biomarker driven phase I/II trial series: the combination of nivolumab and entinostat in children and adolescents with refractory high-risk malignancies Cornelis M. van Tilburg, Ruth Witt, Melanie Heiss, Kristian W. Pajtler, Christoph Plass, Isabel Poschke, Michael Platten, Inga Harting, Oliver Sedlaczek, Angelika Freitag, David Meyrath, Lenka Taylor, Gnana Prakash Balasubramanian, Natalie Jäger, Elke Pfaff, Barbara C. Jones, Till Milde, Stefan M. Pfister, David T. W. Jones, Annette Kopp-Schneider, Olaf Witt BMC Cancer. 2020; 20: 523. Published online 2020 Jun 5. doi: 10.1186/s12885-020-07008-8 PMCID: PMC7275428 AbstractArticlePDF–993K
Number of competitive grants obtained in the last 5 years 6 Publications constitute on one hand the contribution of the network in terms of implication in the design of studies and the recruitment conducted within ITCC, as well as research articles on innovative designs, pre-clinical evaluations and regulatory aspects and clinical trial results.
Access to expert groups Yes - ITCC is a member of the SIOPE Clinical Research Council which is a network of paediatric and adolescent oncology clinical trial groups. -The individual members of the ITCC network form a group of experts in the field of paediatric oncology/haematology and new drug development, including biology, pharmacology and methodology - The ITCC network has established joint programs and collaboration with the European paediatric tumour groups which are in charge of late phase II and phase III trials (e.g. SIOPEN, IBFM, EpSSG, SIOPE-Brain,….). Full Paediatric Investigation Plans can be designed and delivered, up to phase III.
Capacity to answer external scientific questions Yes ITCC tumour Committees provide scientific advice to academic and industry clinical trials. ITCC also has the facility to convene Advisory Boards for industry regarding their drug development in paediatric oncology. Information is available on the ITCC website. Contact by carole.lecinse@gustaveroussy.fr
Site feasibility Yes The Sponsor Network Committee evaluates the capacity of member institution to participate to ITCC trials. Site feasibility is being run by the sponsor.
Participant recruitment Yes Recruitment is performed by the sponsors. ITCC is provided on an annual basis by the sponsor with the recruitment numbers per ITCC centre.
Budget calculation for studies Yes Sponsorship agreement is currently elaborated between the coordinating sponsors within ITCC which will include recommendations for budget calculations.