Clinical trial · Interventional
Ma-Spore ALL 2020 Study
Ma-Spore ALL-Seq 2020: RNA-Seq and IgH/TCR-Seq to Improve Risk Assignment in Childhood, Adolescent and Young Adult Acute Lymphoblastic Leukaemia
NCT06336395CI-TRIAL-00075503recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (16)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dasatinib | Drug | Dasatinib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Erwinase | Drug | Asparaginase | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Standard risk (SR)
- description
- 1. No anthracycline throughout the treatment. 2. CNS consolidation using "Capizzi type" low dose methotrexate (LDMTX) x 2 courses to replace pre-existing high dose methotrexate (HDMTX) 2.5g #3/4
- interventionNames
- Drug: Prednisolone
- Drug: Dexamethasone
- Drug: Vincristine
- Drug: Methotrexate
- Drug: L-Asparaginase
- Drug: Pegylated asparaginase
- Drug: Erwinase
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Mercaptopurine
- Drug: Thioguanine
- type
- EXPERIMENTAL
- label
- Intermediate risk (IR)
- description
- Those with CD20 ≥ 20% expression on diagnostic blasts by flow immunophenotyping will receive additional dose of rituximab on day 1 of each delayed intensification (DI) phases: phase III (2 courses) and V (1 course) for total 3 infusions
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has been diagnosed with B-lineage ALL as evidenced by: 1. BMA blasts \> 20% AND 2. Leukemic process in the bone marrow, peripheral blood or any extra medullary tissue with confirmation of B-lymphoid differentiation by flow immunophenotyping or histopathologically 2. Age \< 41 years of age at enrolment 3. Written informed consent obtained from patient or legally acceptable representative (LAR) Exclusion Criteria: 1. T-lineage ALL 2. Down syndrome with ALL 3. History of previous malignancies or this ALL is a second malignancy 4. Mixed phenotype acute leukemia (MPAL) or undifferentiated leukemia 5. Mature B-cell leukemia/lymphoma 6. 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. 7. 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. 8. Liver dysfunction with direct bilirubin \> 10x upper normal limit for age. 9. Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy 10. Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator
References
Publications (0)
Data not yet available
No reference posted for this study.