| NCT ID | NCT06336395 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National University Hospital, Singapore |
| Condition | B Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-03-04 |
| Primary Completion | 2030-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 500 participants in total. It began in 2020-03-04 with a primary completion date of 2030-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Allen Eng Juh Yeoh, MBBS
PRINCIPAL INVESTIGATOR
Professor
Frequently Asked Questions
Who can join the NCT06336395 clinical trial?
This trial is open to participants of all sexes, up to 40 Years, studying B Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06336395 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06336395 currently recruiting?
Yes, NCT06336395 is actively recruiting participants. Contact the research team at paeyej@nus.edu.sg for enrollment information.
Where is the NCT06336395 trial being conducted?
This trial is being conducted at Kuala Lumpur, Malaysia, Kuala Lumpur, Malaysia, Singapore, Singapore.
Who is sponsoring the NCT06336395 clinical trial?
NCT06336395 is sponsored by National University Hospital, Singapore. The principal investigator is Allen Eng Juh Yeoh, MBBS at Professor. The trial plans to enroll 500 participants.
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