Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT03564704
Status:
UNKNOWN
Last Update Posted:
2018-06-21
First Post:
2018-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult T-LBL/ALL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015458', 'term': 'Leukemia, T-Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D015255', 'term': 'Idarubicin'}, {'id': 'C042705', 'term': 'pegaspargase'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D007621', 'term': 'Karyotyping'}, {'id': 'C547816', 'term': 'N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide'}, {'id': 'D000072078', 'term': 'Positron Emission Tomography Computed Tomography'}], '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': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'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': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'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': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D020732', 'term': 'Cytogenetic Analysis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2018-06-11', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-Free-Survival', 'timeFrame': '3 years', 'description': '3 years EFS of LBL/ALL patients enrolled in PDT-ALL-LBL'}], 'secondaryOutcomes': [{'measure': 'Minimum residual disease after induction', 'timeFrame': '3 months', 'description': 'MRD after induction regimen of PDT-ALL-LBL protocol'}, {'measure': 'CR after Induction Therapy', 'timeFrame': '3 months', 'description': 'CR after induction regimen of PDT-ALL-LBL protocol'}, {'measure': 'Death in induction', 'timeFrame': '3 months', 'description': 'Dearth during induction regimen of PDT-ALL-LBL'}, {'measure': 'Adverse events', 'timeFrame': '3 years', 'description': 'AE of 3 years of LBL patients enrolled in PDT-ALL-LBL'}, {'measure': 'Relapse', 'timeFrame': '3 years', 'description': 'Cumulative incidence relapse rate of 3 years of LBL patients enrolled in PDT-ALL-LBL protocol'}, {'measure': 'Relapse free survival', 'timeFrame': '3 years', 'description': '3 years RFS of LBL patients enrolled in PDT-ALL-LBL protocol'}, {'measure': 'Overall survival', 'timeFrame': '3 years', 'description': '3 years OS of LBL patients enrolled in PDT-ALL-LBL protocol'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leukemia', 'Leukemia, Acute', 'Adult Lymphoblastic Lymphoma', 'Leukemia, Lymphoblastic', 'Leukemia, T Cell', 'Adult Acute Lymphoblastic Leukemia', 'Lymphoblastic Lymphoma', 'Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, one-arm, multi-site trial PDT-ALL-LBL is aimed to evaluate the safety and effect of oral histone deacetylase inhibitor chidamide for adult T-ALL/LBL. Compared to PDT-ALL-2016 for B-ALL, HDACi chidamide will be administrated from induction therapy to maintenance therapy, along with higher dose of consolidation regimen of cytarabine, methotrexate, cyclophosphamide.', 'detailedDescription': 'T-lymphoblastic lymphoma/leukemia is a neoplasm of lymphoblasts committed to the T-cell lineage, typically composed of small to medium-sized blast with scant cytoplasm, moderately condensed to dispersed chromatin, and inconspicuous nucleoli, involving bone marrow and blood or presenting with primary involvement of the thymus or of nodal or extranodal sites. T-ALL/LBL is generally considered a higher-risk disease than B-ALL. Compared to B-ALL, T-LBL/ALL is associated with a higher risk of induction failure, early relapse, and isolated CNS relapse.\n\nChidamide is a novel oral HDACi with promising activity in non-Hodgkin lymphoma (NHL). Chidamide, a new oral isotype-selective HDACi, approved in China for the treatment of R/R PTCL in December 2014. Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, two-arm, multi-site trial PDT-ALL-LBL is aimed to evaluate the safety and effect of oral histone deacetylase inhibitor chidamide for adult T-ALL/LBL. Compared to PDT-ALL-2016 for B-ALL, HDACi chidamide will be administrated from induction therapy to maintenance therapy, along with higher dose of consolidation regimen of cytarabine, methotrexate, cyclophosphamide.\n\nThe intervention of PDT-ALL-LBL consists of diagnostic test (bone marrow aspiration, flow immunophenotyping, karyotyping，FISH, NGS, Flow-MRD), induction regimen (chidamide, dexamethasone, vincristine, cyclophosphamide, Idarubicin, pegaspargase), consolidation regimen (chidamide, prednisone, cytarabine, methotrexate, cyclophosphamide, etoposide, adriamycin, 6-mercaptopurine, pegaspargase), MRD assessment (MRD1/d14, MRD2/d24, MRD3/d45, MRD4/pre-allo-HSCT) and maintenance regimen (chidamide, vincristine, methotrexate, 6-mercaptopurine), intrathecal injection, radiation therapy (for mediastinum- and/or central nervous system-involved lymphoma/leukemia) and allogeneic hematopoietic stem cell transplantation for patients with donor.\n\nInduction Regimen-Pretreatment: dexamethasone, -3d to 0d; Induction regimen VICLD: VCR: d1, d8, d15, d22; IDA: d1, d8; CTX: 1g/m2, 1; PEG-asp: 2000-2500IU/m2, 1, 15; dexamethasone: 1-24; chidamide: 10mg/d, po, qd. Flow-based MRD assessment: d14, d24 during induction regimen, d45, and pre-HSCT. Salvage regimen VLCAM (MRD1/d24\\>1%): CTX, d25; AraC 50mg/m2, d25-31; 6-MP: 25-31, PEG-asp: 2500IU/m2, d26. Consolidation Module (CM)-CM1: AraC 3g/m2, q12h, d1-2, Dex: 10mg/m2, d1-2, PEG-asp: 2, 6-MP: d1-7, chidamide, po qd; CM2: MTX 5g/m2, 1, Dex: 10mg/m2, 1-2, PEG-asp: d2, 6-MP: 1-7, chidamide, po qd; CM3: CTX 1g/m2, 1-3, PEG-asp: 2, 6-MP: 1-7, chidamide, po qd. CM4-6: repeat CM 1-3. Re-Induction: VICLD after CM6. CM7-9: repeat CM1-3. Allo-HSCT: after CM3 when matched-related-donor (MRD), haploidentical related donor (HRD) or matched-unrelated-donor (MUD) available. Non-allo-HSCT: finish CM4-9 and CPOMP maintenance. Maintenance Module-CPOMP: chidamide, po qd for 24 months; Pred: for 12 months; VCR for 12 months; MTX: for 24m months; 6-MP for 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 14-55 years old;\n* LBL/ALL newly diagnosed;\n* signed written informed consent.\n\nExclusion Criteria:\n\n* Pregnant women;\n* History of pancreatitis;\n* History of diabetes;\n* History of active peptic ulcer disease in the past 6 months;\n* History of arteriovenous thrombosis in the past 6 months;\n* Severe active infection;\n* Allergic to any drugs in PDT-ALL-LBL protocol.'}, 'identificationModule': {'nctId': 'NCT03564704', 'briefTitle': 'Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult T-LBL/ALL', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Total Therapy for Adult T-lymphoblastic Lymphoma/Leukemia', 'orgStudyIdInfo': {'id': 'PDT-ALL-LBL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PDT-ALL-LBL', 'description': 'The intervention of PDT-ALL-LBL consists of diagnostic test (bone marrow aspiration, flow immunophenotyping, karyotyping，FISH, NGS, Flow-MRD, PET-CT scan), induction regimen (chidamide, dexamethasone, vincristine, cyclophosphamide, idarubicin, pegaspargase), consolidation regimen (chidamide, prednisone, cytarabine, methotrexate, cyclophosphamide, etoposide, adriamycin, 6-mercaptopurine, pegaspargase), MRD assessment and maintenance regimen (chidamide, prednisone, vincristine, methotrexate, 6-mercaptopurine), intrathecal injection chemotherapy (methotrexate, cytarabine, dexamethasone), radiation therapy (for mediastinum- and/or central nervous system-involved lymphoma/leukemia) and allogeneic hematopoietic stem cell transplantation for patients with donor.', 'interventionNames': ['Drug: Dexamethasone', 'Drug: vincristine', 'Drug: Cyclophosphamide', 'Drug: Idarubicin', 'Drug: Pegaspargase', 'Drug: Adriamycin', 'Drug: Methotrexate', 'Drug: 6-mercaptopurine.', 'Drug: Etoposide', 'Drug: Cytarabine', 'Procedure: Bone marrow aspiration', 'Procedure: Intrathecal injection', 'Radiation: Radiation therapy', 'Genetic: NGS', 'Procedure: allogeneic hematopoietic stem cell transplantation', 'Diagnostic Test: Flow-MRD', 'Diagnostic Test: FISH', 'Diagnostic Test: Flow immunophenotyping', 'Diagnostic Test: Karyotyping', 'Drug: Chidamide', 'Diagnostic Test: PET-CT scan']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['DXM'], 'description': 'Dexamethasone will be added in Pre-phase Regimen, Induction-Regimen, Consolidation-Module of PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'vincristine', 'type': 'DRUG', 'otherNames': ['VCR'], 'description': 'Vincristine will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['CTX'], 'description': 'CTX will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Idarubicin', 'type': 'DRUG', 'otherNames': ['IDA'], 'description': 'IDA will be added to Induction-Regimen and Consolidation-Module of PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Pegaspargase', 'type': 'DRUG', 'otherNames': ['PEG-ASP'], 'description': 'PEG-ASP will be added to Induction-Regimen and Consolidation-Module of PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Adriamycin', 'type': 'DRUG', 'otherNames': ['ADR'], 'description': 'Adriamycin will be added to Consolidation-Module of PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['MTX'], 'description': 'Methotrexate will be added to Consolidation-Module of PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': '6-mercaptopurine.', 'type': 'DRUG', 'otherNames': ['6-MP'], 'description': 'Mercaptopurine will be added to Consolidation-Module and Maintenance-Module of PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['VP-16'], 'description': 'VP-16 will be added to Consolidation-Module of PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['AraC'], 'description': 'AraC will be added to Consolidation-Module of PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Bone marrow aspiration', 'type': 'PROCEDURE', 'otherNames': ['BM smear'], 'description': 'Bone marrow aspiration and additional tests will be performed in all module of PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Intrathecal injection', 'type': 'PROCEDURE', 'otherNames': ['IT'], 'description': 'Intrathecal injection of chemotherapy will be performed in PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Radiation therapy', 'type': 'RADIATION', 'otherNames': ['RT'], 'description': 'Radiation therapy will be performed for mediastinum and/or central nervous system leukemia/lymphoma in PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'NGS', 'type': 'GENETIC', 'description': 'Next-Generation-Sequencing (NGS) will be performed in PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'allogeneic hematopoietic stem cell transplantation', 'type': 'PROCEDURE', 'otherNames': ['Allo-HSCT'], 'description': 'Allo-HSCT will be added to LBL patients with available donor in PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Flow-MRD', 'type': 'DIAGNOSTIC_TEST', 'description': 'Flow-MRD will be added to PDT-ALL-LBL for bone marrow and cerebrospinal fluid samples.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'FISH', 'type': 'DIAGNOSTIC_TEST', 'description': 'FISH will be added to PDT-ALL-LBL for bone marrow samples.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Flow immunophenotyping', 'type': 'DIAGNOSTIC_TEST', 'description': 'Flow immunophenotyping will be performed in PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Karyotyping', 'type': 'DIAGNOSTIC_TEST', 'description': 'Karyotyping will be performed in PDT-ALL-LBL protocol.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'Chidamide', 'type': 'DRUG', 'otherNames': ['HDACi Chidamide'], 'description': 'HDACi chidamide will be added to induction regimen, consolidation and maintenance module of PDT-ALL-LBL.', 'armGroupLabels': ['PDT-ALL-LBL']}, {'name': 'PET-CT scan', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['PET-CT'], 'description': 'PET-scan will be performed for T-LBL patients for MRD assessment in PDT-ALL-LBL.', 'armGroupLabels': ['PDT-ALL-LBL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongsheng Zhou', 'role': 'CONTACT', 'email': 'zhs1@i.smu.edu.cn', 'phone': '+862062787349'}], 'facility': 'Department of Hematology, Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Hongsheng Zhou', 'role': 'CONTACT', 'email': 'zhs1@i.smu.edu.cn', 'phone': '+862062787349'}], 'overallOfficials': [{'name': 'Qifa Liu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Hematology Nanfang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Professor', 'investigatorFullName': 'Qifa Liu', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}