Improving survival in young patients with B-ALL using risk-based therapy
Ma-Spore ALL-Seq 2020: RNA-Seq and IgH/TCR-Seq to Improve Risk Assignment in Childhood, Adolescent and Young Adult Acute Lymphoblastic Leukaemia
This study is testing whether a tailored chemotherapy approach based on genetic risk can improve survival for children and young adults with B-ALL in Singapore and Malaysia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | N/A to 40 Years |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Kuala Lumpur and 2 other locations) |
| Trial ID | NCT06336395 on ClinicalTrials.gov |
What this trial studies
This multicenter open-label phase II trial aims to enhance the overall survival rates of children and young adults under 41 years old diagnosed with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and Malaysia. Participants will be stratified into three risk cohorts based on genetic profiles and treatment responses: Standard Risk, Intermediate Risk, and High Risk. The study will utilize commercially available chemotherapy drugs, including Prednisolone, Dexamethasone, Vincristine, Methotrexate, and L-Asparaginase, without testing any novel agents. The trial focuses on treatment-naïve patients to evaluate the effectiveness of risk-stratified therapy.
Who should consider this trial
Good fit: Ideal candidates are children and young adults under 41 years old who are newly diagnosed with B-lineage acute lymphoblastic leukemia.
Not a fit: Patients with T-lineage ALL, Down syndrome with ALL, or those with a history of previous malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for young patients diagnosed with B-ALL.
How similar studies have performed: Other studies have shown success with risk-stratified approaches in treating B-ALL, indicating potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kuala Lumpur and 2 other locations
- Subang Jaya Medical Centre — Kuala Lumpur, Malaysia (Recruiting)
- University Malaya Medical Centre — Kuala Lumpur, Malaysia (Recruiting)
- KK Women's and Children's Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Allen Eng Juh Yeoh, MBBS — Professor
- Study coordinator: Allen Eng Juh Yeoh, MBBS
- Email: paeyej@nus.edu.sg
- Phone: +65 67724406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.