Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-27 @ 10:41 PM
Study NCT ID:
NCT06336395
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ma-Spore ALL 2020 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D001215', 'term': 'Asparaginase'}, {'id': 'C042705', 'term': 'pegaspargase'}, {'id': 'D000069439', 'term': 'Dasatinib'}, {'id': 'D000068877', 'term': 'Imatinib Mesylate'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D013866', 'term': 'Thioguanine'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'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': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'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'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cumulative incidence (CI) of relapse for all treated cohorts', 'timeFrame': '5 years from diagnosis'}, {'measure': 'Cumulative incidence (CI) of therapy-related mortality (TRM) for all treated subjects', 'timeFrame': '5 years from diagnosis'}], 'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '5 years from diagnosis', 'description': 'OS is calculated from the date of diagnosis to the date of last follow-up or any death'}], 'secondaryOutcomes': [{'measure': 'Event free survival (EFS)', 'timeFrame': '5 years from diagnosis', 'description': 'EFS will be calculated from the date of diagnosis of ALL to date of last follow-up or to the first event, including relapse, resistant disease, second malignancy and death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "This is a multicenter open-label phase II study involving children and young adult (\\< 41 years old) who are newly diagnosed with B-ALL and treatment naïve. There will be 3 parallel cohorts whose risk to be stratified based upon leukemia genetics profiles and patient's treatment response:\n\n1. Standard Risk (SR)\n2. Intermediate Risk (IR)\n3. High Risk (HR)\n\nAll drugs being used are commercially available chemotherapy drugs. There will be no novel chemotherapeutic agent without marketing authorization being tested in this trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has been diagnosed with B-lineage ALL as evidenced by:\n\n 1. BMA blasts \\> 20% AND\n 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\n2. Age \\< 41 years of age at enrolment\n3. Written informed consent obtained from patient or legally acceptable representative (LAR)\n\nExclusion Criteria:\n\n1. T-lineage ALL\n2. Down syndrome with ALL\n3. History of previous malignancies or this ALL is a second malignancy\n4. Mixed phenotype acute leukemia (MPAL) or undifferentiated leukemia\n5. Mature B-cell leukemia/lymphoma\n6. 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.\n7. 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.\n8. Liver dysfunction with direct bilirubin \\> 10x upper normal limit for age.\n9. Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy\n10. 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': 'NCT06336395', 'briefTitle': 'Ma-Spore ALL 2020 Study', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Ma-Spore ALL-Seq 2020: RNA-Seq and IgH/TCR-Seq to Improve Risk Assignment in Childhood, Adolescent and Young Adult Acute Lymphoblastic Leukaemia', 'orgStudyIdInfo': {'id': '2019/00888'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard risk (SR)', 'description': '1. No anthracycline throughout the treatment.\n2. CNS consolidation using "Capizzi type" low dose methotrexate (LDMTX) x 2 courses to replace pre-existing high dose methotrexate (HDMTX) 2.5g #3/4', 'interventionNames': ['Drug: Prednisolone', 'Drug: Dexamethasone', 'Drug: Vincristine', 'Drug: Methotrexate', 'Drug: L-Asparaginase', 'Drug: Pegylated asparaginase', 'Drug: Erwinase', 'Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Mercaptopurine', 'Drug: Thioguanine']}, {'type': 'EXPERIMENTAL', 'label': 'Intermediate risk (IR)', 'description': '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', 'interventionNames': ['Drug: Prednisolone', 'Drug: Dexamethasone', 'Drug: Vincristine', 'Drug: Methotrexate', 'Drug: L-Asparaginase', 'Drug: Pegylated asparaginase', 'Drug: Erwinase', 'Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Mercaptopurine', 'Drug: Thioguanine', 'Drug: Rituximab', 'Drug: Doxorubicin']}, {'type': 'EXPERIMENTAL', 'label': 'High risk (HR)', 'description': 'Provisional HR patients will be offered CAR-T cell immunotherapy or HSCT', 'interventionNames': ['Drug: Prednisolone', 'Drug: Dexamethasone', 'Drug: Vincristine', 'Drug: Methotrexate', 'Drug: L-Asparaginase', 'Drug: Pegylated asparaginase', 'Drug: Erwinase', 'Drug: Dasatinib', 'Drug: Imatinib', 'Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Mercaptopurine', 'Drug: Thioguanine', 'Drug: Doxorubicin', 'Drug: Fludarabine']}], 'interventions': [{'name': 'Prednisolone', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['High risk (HR)', 'Intermediate risk (IR)', 'Standard risk (SR)']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['High risk (HR)', 'Intermediate risk (IR)', 'Standard risk (SR)']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': 'Intravenous', 'armGroupLabels': ['High risk (HR)', 'Intermediate risk (IR)', 'Standard risk (SR)']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Oral/ intrathecal/intravenous/subcutaneous', 'armGroupLabels': ['High risk (HR)', 'Intermediate risk (IR)', 'Standard risk (SR)']}, {'name': 'L-Asparaginase', 'type': 'DRUG', 'description': 'Intramuscular', 'armGroupLabels': ['High risk (HR)', 'Intermediate risk (IR)', 'Standard risk (SR)']}, {'name': 'Pegylated asparaginase', 'type': 'DRUG', 'description': 'Intravenous', 'armGroupLabels': ['High risk (HR)', 'Intermediate risk (IR)', 'Standard risk (SR)']}, {'name': 'Erwinase', 'type': 'DRUG', 'description': 'Optional for those allergic to E.coli/PEG L-asparaginase (intravenous)', 'armGroupLabels': ['High risk (HR)', 'Intermediate risk (IR)', 'Standard risk (SR)']}, {'name': 'Dasatinib', 'type': 'DRUG', 'description': 'Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)', 'armGroupLabels': ['High risk (HR)']}, {'name': 'Imatinib', 'type': 'DRUG', 'description': 'Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)', 'armGroupLabels': ['High risk (HR)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Intravenous', 'armGroupLabels': ['High risk (HR)', 'Intermediate risk (IR)', 'Standard risk (SR)']}, {'name': 'Cytarabine', 'type': 'DRUG', 'description': 'Subcutaneous/ Intravenous', 'armGroupLabels': ['High risk (HR)', 'Intermediate risk (IR)', 'Standard risk (SR)']}, {'name': 'Mercaptopurine', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['High risk (HR)', 'Intermediate risk (IR)', 'Standard risk (SR)']}, {'name': 'Thioguanine', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['High risk (HR)', 'Intermediate risk (IR)', 'Standard risk (SR)']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': 'Intravenous', 'armGroupLabels': ['Intermediate risk (IR)']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Intravenous', 'armGroupLabels': ['High risk (HR)', 'Intermediate risk (IR)']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Intravenous', 'armGroupLabels': ['High risk (HR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47500', 'city': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Hai Peng Lin', 'role': 'CONTACT', 'email': 'flslhp@gmail.com', 'phone': '+603 56391621'}, {'name': 'Lee Lee Chan, MBBS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Subang Jaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '59100', 'city': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Hany Arrifin, MBBS', 'role': 'CONTACT', 'email': 'hany@ummc.edu.my', 'phone': '+603 79492065'}], 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '229899', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Ah Moy Tan, MBBS', 'role': 'CONTACT', 'email': 'tan.ah.moy01@singhealth.com.sg', 'phone': '+65 63941039'}], 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Allen Eng Juh Yeoh, MBBS', 'role': 'CONTACT', 'email': 'paeyej@nus.edu.sg', 'phone': '+65 67724406'}], 'overallOfficials': [{'name': 'Allen Eng Juh Yeoh, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}