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
60 participants
INTERVENTIONAL
2017-04-18
2033-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SR
Standard Risk (SR) :
CNS 3 or CNS 2 regardless of response OR Time-point #1 (Day 15 induction) Flow MRD ≥ 1% (treatment will not be de-escalated even MRD \<0.01% by TP#2) OR Time-point #2 (Day 1 IDMTX/MP of Consolidation) ≥0.01%
SR strategy:
All SR patient will have to receive two doses of anthracycline and 12 L-asparaginase doses during induction except those who are escalated to SR at time point 2 when MRD ≥0.01%.
During the first year of maintenance phase (48 weeks; 4x12 weeks blocks), cyclophosphamide and cytarabine bolus will be administered at 4 weekly interval.
Daunorubicin
Given IV
Prednisolone
Given PO or IV
Vincristine
Given IV
Epirubicin
Given IV
E-coli L-asparaginase
Given IM or IV
6-Mercaptopurine
Given PO
Methotrexate
Given IV, PO or IT
Hydrocortisone
Given IT
Cytarabine
Given IV, IT or SC
Cyclophosphamide
Given IV
LR
Low Risk (LR):
Time-point #1 (Day 15 induction) Flow MRD \<1% AND Time-point #2 (Day 1 IDMTX/MP of Consolidation) \<0.01% AND CNS 1 only
LR strategy:
For LR patients, one dose of anthracycline and 3 doses of L-asparaginase will be omitted during induction.
Following re-induction I, interim maintenance and additional block of re-induction ie. re-induction II prior to maintenance phase will be omitted for LR patients.
Daunorubicin
Given IV
Prednisolone
Given PO or IV
Vincristine
Given IV
Epirubicin
Given IV
E-coli L-asparaginase
Given IM or IV
6-Mercaptopurine
Given PO
Methotrexate
Given IV, PO or IT
Hydrocortisone
Given IT
Interventions
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Daunorubicin
Given IV
Prednisolone
Given PO or IV
Vincristine
Given IV
Epirubicin
Given IV
E-coli L-asparaginase
Given IM or IV
6-Mercaptopurine
Given PO
Methotrexate
Given IV, PO or IT
Hydrocortisone
Given IT
Cytarabine
Given IV, IT or SC
Cyclophosphamide
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed ALL according to WHO 2016 classification.
* Age \< 21 years old at time of enrollment.
* ECOG performance status (PS) score of 0-2.
* Written informed consent obtained from legally acceptable representatives.
Exclusion Criteria
* Philadelphia positive ALL.
* Mature B-ALL.
* Mixed phenotype acute leukemia.
* Any previous treatment with cytotoxic chemotherapy excluding treatment for TAM or radiation therapy. Patient pre-treated with short term steroid (\< 7 days of duration within last 1 month prior to treatment start) can be enrolled into this study.
* Renal dysfunction with creatinine \>2x upper limit of normal (ULN). Patients whose creatinine has improved to \<2x ULN before treatment commencement can enrol subject to discretion of site PI.
* Liver dysfunction with direct bilirubin \> 5x ULN.
* Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy, including:
1. History of coronary arterial disease, cardiomyopathy, heart failure, arrhythmia (other than sinus arrhythmia) or severe cardiac malformation which with residual abnormalities or requires further major corrective surgery within 2 years.
2. Ongoing uncontrolled hypertension.
3. Ongoing uncontrolled diabetes mellitus.
4. Ongoing uncontrolled infection.
5. History of congenital or acquired immunodeficiency including HIV infection.
6. History of interstitial pneumonia, pulmonary fibrosis, bronchiectasis or severe pulmonary emphysema.
7. CNS hemorrhage.
8. Psychiatric disorder.
9. Other concurrent active neoplasms.
* Pregnant or lactating women.
* Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator.
0 Years
20 Years
ALL
No
Sponsors
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National Hospital Organization Nagoya Medical Center
OTHER
Responsible Party
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Principal Investigators
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Allen Yeoh, MBBS
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Kagoshima University Hospital
Kagoshima, , Japan
University of Malaya Medical Centre
Kuala Lumpur, , Malaysia
Subang Jaya Medical Centre
Subang Jaya, , Malaysia
National University Hospital
Singapore, , Singapore
KK Women's and Children's Hospital
Singapore, , Singapore
National Taiwan University Children's Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Chang Gung Memorial Hopsital, Linkou
Taoyuan District, , Taiwan
Siriraj Hospital Mahidol University
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ASIA-DS-ALL-2016
Identifier Type: -
Identifier Source: org_study_id
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