Improving survival in young patients with B-ALL using risk-based therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.