CCCG Relapsed Acute Lymphoblastic Leukemia 2017 Study in Children
Status:
Recruiting
Trial end date:
2024-08-31
Target enrollment:
Participant gender:
Summary
Relapsed acute lymphoblastic leukaemia (ALL) has a poorer outcome than newly diagnosed ALL
patients with only about 40% overall survival after re-treatment. The study CCCG Relapsed ALL
2017 study will adopt the UK R3 study stratification and treatment backbone with two new
agents added. There will be a 4-week induction, followed by two consolidation courses.
High-risk patients will receive allogeneic stem cell transplant. While intermediate and
standard risk groups will continue maintenance treatment for another 2 years or one year. New
agents will be added aiming at improving survival outcome.
1. Study of adding anti-CD20 antibody (rituximab) with chemotherapy: CD20 is found to be
expressed in 40-50% of B-lineage ALL, and rituximab has been studied in adult ALL with
superior survival (75% vs 47%,). There is little experience of using rituximab in
pediatric ALL thus a CCCG Relapsed ALL 2017 Study will perform the study assessing the
remission rate and MRD response of CD20+ ALL treated with rituximab. Six doses of
rituximab and will be monitored the week 5 MRD and relapse rate as study outcome.
(This arm was terminated in October 2020 after interim analysis showing lack of
efficacy)
2. Adding bortezomid during the induction: The very early or early bone marrow relapse has
low remission rate. Previous case studies showed that Bortezomib, a proteasome
inhibitor, may achieve remission in refractory ALL, 80% remission in B-ALL with
combination of chemotherapy and bortezomib. Thus adding bortezomib, may improve the
remission rate, thus bridging to allogeneic stem cell transplant. Adding bortezomib in
the relapsed chemotherapy protocol may increase the toxicity and even treatment related
mortality. In this protocol, we suggested to add during the induction therapy.