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New treatment option for B Lymphoblastic Leukemia
Official title Ma-Spore ALL 2020 Study
ClinicalTrials.gov ID: NCT06336395
What this study is testing
What is Prednisolone?
Prednisolone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for b lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 40
You may be able to join if
- 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...
- Age \< 41 years of age at enrolment
- Written informed consent obtained from patient or legally acceptable representative (LAR)
You likely can't join if
- T-lineage ALL
- Down syndrome with ALL
- History of previous malignancies or this ALL is a second malignancy
- Mixed phenotype acute leukemia (MPAL) or undifferentiated leukemia
- Mature B-cell leukemia/lymphoma
- Any previous cytotoxic therapy (chemotherapy/radiotherapy/immunotherapy). Patient pre-treated with short term steroid (\< 7 days of duration within...
See the full eligibility criteria
- 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)
- T-lineage ALL
- Down syndrome with ALL
- History of previous malignancies or this ALL is a second malignancy
- Mixed phenotype acute leukemia (MPAL) or undifferentiated leukemia
- Mature B-cell leukemia/lymphoma
- 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...
- 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.
- Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy
- Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator
The study team makes the final eligibility decision.
Where it's taking place
- Kuala Lumpur, Malaysia
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kuala Lumpur, Malaysia; Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.