Tests risk-based treatment in children and young adults with B-cell acute lymphoblastic leukemia
Tests risk-based chemotherapy in children and young adults with B-lineage acute lymphoblastic leukemia.
Plain-language title generated from the registry record
Registry title: Ma-Spore ALL 2020 Study
Key facts
- Where
- Kuala Lumpur, MalaysiaSee the 2 sites
- Phase
- Phase 2
Where in Malaysia
- Subang Jaya Medical CentreKuala Lumpur, MalaysiaTaking people
- University Malaya Medical CentreKuala Lumpur, MalaysiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National University Hospital, Singapore
- Trial code
- NCT06336395
- Record updated
- 28 March 2024
- Original description
The primary objective of this trial is to improve the overall survival rate of children and young adult with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and Malaysia in the context of a multicenter cooperative trial using a risk-stratified therapy.Read full original descriptionShow less
Ma-Spore ALL-Seq 2020: RNA-Seq and IgH/TCR-Seq to Improve Risk Assignment in Childhood, Adolescent and Young Adult Acute Lymphoblastic Leukaemia
The primary objective of this trial is to improve the overall survival rate of children and young adult with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and Malaysia in the context of a multicenter cooperative trial using a risk-stratified therapy.
Inclusion: Has been diagnosed with B-lineage ALL as evidenced by:; BMA blasts > 20% AND; Leukemic process in the bone marrow, peripheral blood or any extra medullary tissue with confirmation of B-lymphoid differentiation by flow immunophenotyping or histopathologically; Age < 41 years of age at enrolment; Written informed consent obtained from patient or legally acceptable representative (LAR).
Exclusion: Any previous cytotoxic therapy (chemotherapy/radiotherapy/immunotherapy). Patient pre-treated with short term steroid (< 7 days of duration within last 1 month prior to ALL treatment start) may be enrolled after discussion and written approval from PI. These patients should be treated on at least intermediate arm; Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator; Down syndrome with ALL; History of previous malignancies or this ALL is a second malignancy; Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy; Persistent renal dysfunction with creatinine more than upper limit of normal for age before start of induction therapy. Patients requiring temporary dialysis without persistent renal dysfunction can qualify; Liver dysfunction with direct bilirubin > 10x upper normal limit for age; T-lineage ALL; Mixed phenotype acute leukemia (MPAL) or undifferentiated leukemia; Mature B-cell leukemia/lymphoma.