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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form obtained from patient or legally acceptable representative (LAR) Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Prednisolone

Oral

DRUG

Dexamethasone

Oral

DRUG

Vincristine

Intravenous

DRUG

Methotrexate

Oral/ intrathecal/intravenous/subcutaneous

DRUG

L-Asparaginase

Intramuscular

DRUG

Pegylated asparaginase

Intravenous

DRUG

Erwinase

Optional for those allergic to E.coli/PEG L-asparaginase (intravenous)

DRUG

Dasatinib

Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)

DRUG

Imatinib

Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)

DRUG

Cyclophosphamide

Intravenous

DRUG

Cytarabine

Subcutaneous/ Intravenous

DRUG

Mercaptopurine

Oral

DRUG

Thioguanine

Oral

DRUG

Rituximab

Intravenous

DRUG

Doxorubicin

Intravenous

DRUG

Fludarabine

Intravenous

Locations (3)

Subang Jaya Medical Centre
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
KK Women's and Children's Hospital
Singapore, Singapore