Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-28 @ 5:07 AM
Study NCT ID:
NCT03286634
Status:
RECRUITING
Last Update Posted:
2022-09-28
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'C036266', 'term': 'prednylidene'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'risk stratification-directed chemotherapy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2033-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event Free Survival', 'timeFrame': 'Up to 5 years', 'description': 'Percentage of patients who are event free at 5 years.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 5 years', 'description': 'Percentage of patients who survive at 5 years.'}, {'measure': 'Disease free survival', 'timeFrame': 'Up to 5 years', 'description': 'Percentage of patients who are leukemia free at 5 years.'}, {'measure': 'Induction failure', 'timeFrame': '5 weeks', 'description': 'Percentage of patients who had failed induction.'}, {'measure': 'Complete remission rate', 'timeFrame': '5 weeks', 'description': 'Percentage of patients who had achieved complete remission at the end of induction.'}, {'measure': 'Cumulative incidence of relapse', 'timeFrame': 'Up to 5 years'}, {'measure': 'Incidence of treatment-related adverse events', 'timeFrame': 'Up to 10 years', 'description': 'Incidence of treatment-related infectious and metabolic complications (throughout various phases of study therapy) and secondary neoplasms.'}, {'measure': 'Flow MRD at day 15', 'timeFrame': 'At day 15 of induction therapy', 'description': 'To assess the prognostic value flow MRD level during induction for DS-ALL.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Down Syndrome', 'Acute Lymphoblastic Leukemia', 'Childhood Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the outcome of a prednisolone and low dose methotrexate based protocol in Down syndrome children with ALL (DS-ALL) in an Asia-wide study. The treatment protocol was modified based upon backbone of Taiwan Pediatric Oncology Group (TPOG)-ALL protocol in which risk classification will be guided by level of flow minimal residual disease (MRD) instead.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Down syndrome diagnosed clinically or cytogenetically (including Mosaic Down)\n* Newly diagnosed ALL according to WHO 2016 classification.\n* Age \\< 21 years old at time of enrollment.\n* ECOG performance status (PS) score of 0-2.\n* Written informed consent obtained from legally acceptable representatives.\n\nExclusion Criteria:\n\n* Second malignancy.\n* Philadelphia positive ALL.\n* Mature B-ALL.\n* Mixed phenotype acute leukemia.\n* 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.\n* 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.\n* Liver dysfunction with direct bilirubin \\> 5x ULN.\n* Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy, including:\n\n 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.\n 2. Ongoing uncontrolled hypertension.\n 3. Ongoing uncontrolled diabetes mellitus.\n 4. Ongoing uncontrolled infection.\n 5. History of congenital or acquired immunodeficiency including HIV infection.\n 6. History of interstitial pneumonia, pulmonary fibrosis, bronchiectasis or severe pulmonary emphysema.\n 7. CNS hemorrhage.\n 8. Psychiatric disorder.\n 9. Other concurrent active neoplasms.\n* Pregnant or lactating women.\n* Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator.'}, 'identificationModule': {'nctId': 'NCT03286634', 'briefTitle': 'ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016', 'organization': {'class': 'OTHER', 'fullName': 'National Hospital Organization Nagoya Medical Center'}, 'officialTitle': 'Asia-wide, Multicenter Open-label, Phase II Non-randomised Study Involving Children With Down Syndrome Under 21 Year-old With Newly Diagnosed, Treatment naïve Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': 'ASIA-DS-ALL-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SR', 'description': 'Standard Risk (SR) :\n\nCNS 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%\n\nSR strategy:\n\nAll 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%.\n\nDuring the first year of maintenance phase (48 weeks; 4x12 weeks blocks), cyclophosphamide and cytarabine bolus will be administered at 4 weekly interval.', 'interventionNames': ['Drug: Daunorubicin', 'Drug: Prednisolone', 'Drug: Vincristine', 'Drug: Epirubicin', 'Drug: E-coli L-asparaginase', 'Drug: 6-Mercaptopurine', 'Drug: Methotrexate', 'Drug: Hydrocortisone', 'Drug: Cytarabine', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'LR', 'description': 'Low Risk (LR):\n\nTime-point #1 (Day 15 induction) Flow MRD \\<1% AND Time-point #2 (Day 1 IDMTX/MP of Consolidation) \\<0.01% AND CNS 1 only\n\nLR strategy:\n\nFor LR patients, one dose of anthracycline and 3 doses of L-asparaginase will be omitted during induction.\n\nFollowing 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.', 'interventionNames': ['Drug: Daunorubicin', 'Drug: Prednisolone', 'Drug: Vincristine', 'Drug: Epirubicin', 'Drug: E-coli L-asparaginase', 'Drug: 6-Mercaptopurine', 'Drug: Methotrexate', 'Drug: Hydrocortisone']}], 'interventions': [{'name': 'Daunorubicin', 'type': 'DRUG', 'otherNames': ['DNR'], 'description': 'Given IV', 'armGroupLabels': ['LR', 'SR']}, {'name': 'Prednisolone', 'type': 'DRUG', 'otherNames': ['Pred'], 'description': 'Given PO or IV', 'armGroupLabels': ['LR', 'SR']}, {'name': 'Vincristine', 'type': 'DRUG', 'otherNames': ['VCR'], 'description': 'Given IV', 'armGroupLabels': ['LR', 'SR']}, {'name': 'Epirubicin', 'type': 'DRUG', 'otherNames': ['EPI'], 'description': 'Given IV', 'armGroupLabels': ['LR', 'SR']}, {'name': 'E-coli L-asparaginase', 'type': 'DRUG', 'otherNames': ['E-coli L-Asp'], 'description': 'Given IM or IV', 'armGroupLabels': ['LR', 'SR']}, {'name': '6-Mercaptopurine', 'type': 'DRUG', 'otherNames': ['6-MP'], 'description': 'Given PO', 'armGroupLabels': ['LR', 'SR']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['MTX'], 'description': 'Given IV, PO or IT', 'armGroupLabels': ['LR', 'SR']}, {'name': 'Hydrocortisone', 'type': 'DRUG', 'description': 'Given IT', 'armGroupLabels': ['LR', 'SR']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['Ara-C'], 'description': 'Given IV, IT or SC', 'armGroupLabels': ['SR']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cy'], 'description': 'Given IV', 'armGroupLabels': ['SR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'state': 'New Territories', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Chi Kong Li, MBBS', 'role': 'CONTACT', 'email': 'ckli@cuhk.edu.hk'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'zip': '890-8544', 'city': 'Kagoshima', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yasuhiro Okamoto', 'role': 'CONTACT', 'email': 'okamoto@m2.kufm.kagoshima-u.ac.jp'}], 'facility': 'Kagoshima University Hospital', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '59100', 'city': 'Kuala Lumpur', 'status': 'NOT_YET_RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Hany Arrifin, MBBS', 'role': 'CONTACT', 'email': 'hany@ummc.edu.my'}], 'facility': 'University of Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '47500', 'city': 'Subang Jaya', 'status': 'NOT_YET_RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Hai Peng Lin, MBBS', 'role': 'CONTACT', 'email': 'flslhp@gmail.com'}, {'name': 'Lee Lee Chan, MBBS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Subang Jaya Medical Centre', 'geoPoint': {'lat': 3.04384, 'lon': 101.58062}}, {'zip': '119074', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Allen Yeoh, MBBS', 'role': 'CONTACT', 'email': 'allen_yeoh@nuhs.edu.sg'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '229899', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Ah Moy Tan, MBBS', 'role': 'CONTACT', 'email': 'tan.ah.moy01@singhealth.com.sg'}], 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '100', 'city': 'Taipei', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Tsamn Lin Dong, MD', 'role': 'CONTACT', 'email': 'dtlin@ntuh.gov.tw'}], 'facility': "National Taiwan University Children's Hospital", 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10449', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsi-Che Liu, MD', 'role': 'CONTACT', 'email': 'hsiche@mmh.org.tw'}], 'facility': 'Mackay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shih-Hsiang Chen, MD', 'role': 'CONTACT', 'email': 'samechen@cgmh.org.tw'}], 'facility': 'Chang Gung Memorial Hopsital, Linkou', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': '10700', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Jassada Buaboonnam, MD', 'role': 'CONTACT', 'email': 'onco008@yahoo.com'}], 'facility': 'Siriraj Hospital Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Allen Yeoh, MBBS', 'role': 'CONTACT', 'email': 'paeyej@nus.edu.sg', 'phone': '(65) 67724406'}], 'overallOfficials': [{'name': 'Allen Yeoh, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Hospital Organization Nagoya Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}