Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
500 participants
INTERVENTIONAL
2020-03-04
2030-03-31
Brief Summary
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Detailed Description
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1. Standard Risk (SR)
2. Intermediate Risk (IR)
3. High Risk (HR)
All drugs being used are commercially available chemotherapy drugs. There will be no novel chemotherapeutic agent without marketing authorization being tested in this trial.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard risk (SR)
1. No anthracycline throughout the treatment.
2. CNS consolidation using "Capizzi type" low dose methotrexate (LDMTX) x 2 courses to replace pre-existing high dose methotrexate (HDMTX) 2.5g #3/4
Prednisolone
Oral
Dexamethasone
Oral
Vincristine
Intravenous
Methotrexate
Oral/ intrathecal/intravenous/subcutaneous
L-Asparaginase
Intramuscular
Pegylated asparaginase
Intravenous
Erwinase
Optional for those allergic to E.coli/PEG L-asparaginase (intravenous)
Cyclophosphamide
Intravenous
Cytarabine
Subcutaneous/ Intravenous
Mercaptopurine
Oral
Thioguanine
Oral
Intermediate risk (IR)
Those with CD20 ≥ 20% expression on diagnostic blasts by flow immunophenotyping will receive additional dose of rituximab on day 1 of each delayed intensification (DI) phases: phase III (2 courses) and V (1 course) for total 3 infusions
Prednisolone
Oral
Dexamethasone
Oral
Vincristine
Intravenous
Methotrexate
Oral/ intrathecal/intravenous/subcutaneous
L-Asparaginase
Intramuscular
Pegylated asparaginase
Intravenous
Erwinase
Optional for those allergic to E.coli/PEG L-asparaginase (intravenous)
Cyclophosphamide
Intravenous
Cytarabine
Subcutaneous/ Intravenous
Mercaptopurine
Oral
Thioguanine
Oral
Rituximab
Intravenous
Doxorubicin
Intravenous
High risk (HR)
Provisional HR patients will be offered CAR-T cell immunotherapy or HSCT
Prednisolone
Oral
Dexamethasone
Oral
Vincristine
Intravenous
Methotrexate
Oral/ intrathecal/intravenous/subcutaneous
L-Asparaginase
Intramuscular
Pegylated asparaginase
Intravenous
Erwinase
Optional for those allergic to E.coli/PEG L-asparaginase (intravenous)
Dasatinib
Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)
Imatinib
Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)
Cyclophosphamide
Intravenous
Cytarabine
Subcutaneous/ Intravenous
Mercaptopurine
Oral
Thioguanine
Oral
Doxorubicin
Intravenous
Fludarabine
Intravenous
Interventions
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Prednisolone
Oral
Dexamethasone
Oral
Vincristine
Intravenous
Methotrexate
Oral/ intrathecal/intravenous/subcutaneous
L-Asparaginase
Intramuscular
Pegylated asparaginase
Intravenous
Erwinase
Optional for those allergic to E.coli/PEG L-asparaginase (intravenous)
Dasatinib
Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)
Imatinib
Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)
Cyclophosphamide
Intravenous
Cytarabine
Subcutaneous/ Intravenous
Mercaptopurine
Oral
Thioguanine
Oral
Rituximab
Intravenous
Doxorubicin
Intravenous
Fludarabine
Intravenous
Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
ALL
No
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Allen Eng Juh Yeoh, MBBS
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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Subang Jaya Medical Centre
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
KK Women's and Children's Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019/00888
Identifier Type: -
Identifier Source: org_study_id
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