drugset / Trial / NCT04307576
A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
Phase 3
Recruiting
6430 enrolled
Mats Heyman
Aamu Pediatric Cancer Foundation · collabAcreditar - Associação de Pais e Amigos das Crianças com Cancro · collabAmgen · collabAssistance Publique - Hôpitaux de Paris · collabBelgium Health Care Knowledge Centre · collabCancer Research UK · collabClinical Trial Center North (CTC North GmbH & Co. KG) · collabDanish Cancer Society · collabDanish Child Cancer Foundation · collabDirection Générale de l'Offre de Soins · collabFundação Rui Osório de Castro · collabGerman Society for Pediatric Oncology and Hematology GPOH gGmbH · collabGrupo Português De Leucemias Pediátricas · collabKarolinska Institutet · collabNordForsk · collabNova Laboratories Limited · collabPfizer · collabServier · collabSwedish Cancer Society · collabThe Novo Nordic Foundation · collabThe Swedish Childhood Cancer Foundation · collabThe Swedish Research Council · collab
RandomizedSequentialOpen-labelTreatment
Summary
ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design.
Timeline
- Start
- 2020-07-13
- Primary completion
- 2033-06
- Completion
- 2033-06
Publications
- Background Toft N, Birgens H, Abrahamsson J, Griskevicius L, Hallbook H, Heyman M, Klausen TW, Jonsson OG, Palk K, Pruunsild K, Quist-Paulsen P, Vaitkeviciene G, Vettenranta K, Asberg A, Frandsen TL, Marquart HV, Madsen HO, Noren-Nystrom U, Schmiegelow K. Results of NOPHO ALL2008 treatment for patients aged 1-45 years with acute lymphoblastic leukemia. Leukemia. 2018 Mar;32(3):606-615. doi: 10.1038/leu.2017.265. Epub 2017 Aug 18.
- Background Schramm F, Zimmermann M, Jorch N, Pekrun A, Borkhardt A, Imschweiler T, Christiansen H, Faber J, Feuchtinger T, Schmid I, Beron G, Horstmann MA, Escherich G. Daunorubicin during delayed intensification decreases the incidence of infectious complications - a randomized comparison in trial CoALL 08-09. Leuk Lymphoma. 2019 Jan;60(1):60-68. doi: 10.1080/10428194.2018.1473575. Epub 2018 Jul 3.
- Background Mondelaers V, Suciu S, De Moerloose B, Ferster A, Mazingue F, Plat G, Yakouben K, Uyttebroeck A, Lutz P, Costa V, Sirvent N, Plouvier E, Munzer M, Poiree M, Minckes O, Millot F, Plantaz D, Maes P, Hoyoux C, Cave H, Rohrlich P, Bertrand Y, Benoit Y; Children-s Leukemia Group (CLG) of the European Organization for Research and Treatment of Cancer (EORTC). Prolonged versus standard native E. coli asparaginase therapy in childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma: final results of the EORTC-CLG randomized phase III trial 58951. Haematologica. 2017 Oct;102(10):1727-1738. doi: 10.3324/haematol.2017.165845. Epub 2017 Jul 27.
- Background Vora A, Goulden N, Wade R, Mitchell C, Hancock J, Hough R, Rowntree C, Richards S. Treatment reduction for children and young adults with low-risk acute lymphoblastic leukaemia defined by minimal residual disease (UKALL 2003): a randomised controlled trial. Lancet Oncol. 2013 Mar;14(3):199-209. doi: 10.1016/S1470-2045(12)70600-9. Epub 2013 Feb 7.
- Background Pieters R, de Groot-Kruseman H, Van der Velden V, Fiocco M, van den Berg H, de Bont E, Egeler RM, Hoogerbrugge P, Kaspers G, Van der Schoot E, De Haas V, Van Dongen J. Successful Therapy Reduction and Intensification for Childhood Acute Lymphoblastic Leukemia Based on Minimal Residual Disease Monitoring: Study ALL10 From the Dutch Childhood Oncology Group. J Clin Oncol. 2016 Aug 1;34(22):2591-601. doi: 10.1200/JCO.2015.64.6364. Epub 2016 Jun 6.
- Toksvang LN, Als-Nielsen B, Bacon C, Bertasiute R, Duarte X, Escherich G, Helgadottir EA, Johannsdottir IR, Jonsson OG, Kozlowski P, Langenskjold C, Lepik K, Niinimaki R, Overgaard UM, Punab M, Raty R, Segers H, van der Sluis I, Smith OP, Strullu M, Vaitkeviciene G, Wik HS, Heyman M, Schmiegelow K. Thiopurine Enhanced ALL Maintenance (TEAM): study protocol for a randomized study to evaluate the improvement in disease-free survival by adding very low dose 6-thioguanine to 6-mercaptopurine/methotrexate-based maintenance therapy in pediatric and adult patients (0-45 years) with newly diagnosed B-cell precursor or T-cell acute lymphoblastic leukemia treated according to the intermediate risk-high group of the ALLTogether1 protocol. BMC Cancer. 2022 May 2;22(1):483. doi: 10.1186/s12885-022-09522-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 6-tioguanine | Unknown | 2.5 mg/m2 | Oral |
| Subject | 6-tioguanine | Unknown | 12.5 mg/m2 | Oral |
| Subject | Blinatumomab | Monoclonal antibody | 5 ug/m2 | Intravenous |
| Subject | Blinatumomab | Monoclonal antibody | 28 ug | Intravenous |
| Subject | Imatinib | Small molecule | 340 mg/m2 | Oral |
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | 0.5 mg/m2 | Intravenous |