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.
Adolescent
Adult
Child
Child, Preschool
Disease-Free Survival
Humans
Infant
Infant, Newborn
Mercaptopurine
Methotrexate
Middle Aged
Precursor Cell Lymphoblastic Leukemia-Lymphoma
/ drug therapy
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
/ drug therapy
Randomized Controlled Trials as Topic
Recurrence
Risk Factors
T-Lymphocytes
Thioguanine
/ therapeutic use
Young Adult
6-mercaptopurine
6-thioguanine
Acute lymphoblastic leukemia
DNA-TG
Maintenance
Methotrexate
Thiopurines
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
02 May 2022
02 May 2022
Historique:
received:
21
01
2022
accepted:
10
04
2022
entrez:
3
5
2022
pubmed:
4
5
2022
medline:
6
5
2022
Statut:
epublish
Résumé
A critical challenge in current acute lymphoblastic leukemia (ALL) therapy is treatment intensification in order to reduce the relapse rate in the subset of patients at the highest risk of relapse. The year-long maintenance phase is essential in relapse prevention. The Thiopurine Enhanced ALL Maintenance (TEAM) trial investigates a novel strategy for ALL maintenance. TEAM is a randomized phase 3 sub-protocol to the ALLTogether1 trial, which includes patients 0-45 years of age with newly diagnosed B-cell precursor or T-cell ALL, and stratified to the intermediate risk-high (IR-high) group, in 13 European countries. In the TEAM trial, the traditional methotrexate (MTX)/6-mercaptopurine (6MP) maintenance backbone (control arm) is supplemented with low dose (2.5-12.5 mg/m TEAM provides a novel strategy for maintenance therapy in ALL with the potential of improving DFS through reducing relapse rate. Potential risk factors that have been considered include hepatic sinusoidal obstruction syndrome/nodular regenerative hyperplasia, second cancer, infection, and osteonecrosis. Metabolite monitoring can potentially increase treatment adherence in both treatment arms. EudraCT, 2018-001795-38. Registered 2020-05-15, Clinicaltrials.gov , NCT04307576 . Registered 2020-03-13, https://clinicaltrials.gov/ct2/show/NCT04307576.
Sections du résumé
BACKGROUND
BACKGROUND
A critical challenge in current acute lymphoblastic leukemia (ALL) therapy is treatment intensification in order to reduce the relapse rate in the subset of patients at the highest risk of relapse. The year-long maintenance phase is essential in relapse prevention. The Thiopurine Enhanced ALL Maintenance (TEAM) trial investigates a novel strategy for ALL maintenance.
METHODS
METHODS
TEAM is a randomized phase 3 sub-protocol to the ALLTogether1 trial, which includes patients 0-45 years of age with newly diagnosed B-cell precursor or T-cell ALL, and stratified to the intermediate risk-high (IR-high) group, in 13 European countries. In the TEAM trial, the traditional methotrexate (MTX)/6-mercaptopurine (6MP) maintenance backbone (control arm) is supplemented with low dose (2.5-12.5 mg/m
DISCUSSION
CONCLUSIONS
TEAM provides a novel strategy for maintenance therapy in ALL with the potential of improving DFS through reducing relapse rate. Potential risk factors that have been considered include hepatic sinusoidal obstruction syndrome/nodular regenerative hyperplasia, second cancer, infection, and osteonecrosis. Metabolite monitoring can potentially increase treatment adherence in both treatment arms.
TRIAL REGISTRATION
BACKGROUND
EudraCT, 2018-001795-38. Registered 2020-05-15, Clinicaltrials.gov , NCT04307576 . Registered 2020-03-13, https://clinicaltrials.gov/ct2/show/NCT04307576.
Identifiants
pubmed: 35501736
doi: 10.1186/s12885-022-09522-3
pii: 10.1186/s12885-022-09522-3
pmc: PMC9063225
doi:
Substances chimiques
Mercaptopurine
E7WED276I5
Thioguanine
FTK8U1GZNX
Methotrexate
YL5FZ2Y5U1
Banques de données
ClinicalTrials.gov
['NCT04307576']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
483Subventions
Organisme : Novo Nordisk Fonden
ID : NNF19OC0056458
Organisme : Kræftens Bekæmpelse
ID : R231-A14071-B34
Organisme : Børnecancerfonden
ID : 2017-2034
Organisme : Børnecancerfonden
ID : 2018-3705
Organisme : Barncancerfonden
ID : KP2018-0008
Informations de copyright
© 2022. The Author(s).
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