Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2026-01-02 @ 2:57 AM
Study NCT ID:
NCT05024357
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2021-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of TKI Maintenance Therapy Following Allo-HSCT in Newly Diagnosed Ph+ Adult ALL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D000069439', 'term': 'Dasatinib'}], 'ancestors': [{'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2021-08-26', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients with Measurable Residual Disease (MRD) Positivity', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.', 'description': 'MRD means the subclinical levels of residual leukemia.'}, {'measure': 'Percentage of Patients with Complete Remission (CR)', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.', 'description': 'CR means that the blood counts have returned to normal, the leukemia cannot be seen when a bone marrow sample is examined under the microscope, and the signs and symptoms of the ALL are gone.'}], 'secondaryOutcomes': [{'measure': 'Disease-free Survival (DFS), months', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.', 'description': 'The measure of time after allo-HSCT during which no sign of ALL is found.'}, {'measure': 'Overall Survival (OS), months', 'timeFrame': 'From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months.', 'description': 'The length of time from the date of allo-HSCT that Ph+ ALL patients are still alive.'}, {'measure': 'Non-relapse Mortality (NRM), rate or percentage', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.', 'description': 'NRM means death without recurrent or progressive disease after allo-HSCT.'}, {'measure': 'Incidence of graft versus host disease (GVHD), rate or percentage', 'timeFrame': 'From date of randomization until the date of GVHD occurrence or date of death from any cause, whichever came first, assessed up to 36 months.', 'description': "GVHD is a condition that might occur after allo-HSCT. In GVHD, the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body."}, {'measure': 'Adverse Effects (AE)', 'timeFrame': 'From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months.', 'description': 'An adverse effect is any untoward medical occurrence in clinical investigation subject administered dasatinib and which does not necessarily have a causal relationship with this treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Philadelphia-Positive', 'Adult Acute Lymphoblastic Leukemia', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'Tyrosine Kinase Inhibitors'], 'conditions': ['Precursor Cell Lymphoblastic Leukemia-Lymphoma', 'Philadelphia-Positive Acute Lymphoblastic Leukemia', 'ALL, Adult']}, 'descriptionModule': {'briefSummary': "This project is a key clinical research project approved by the Clinical Research Center of the First Affiliated Hospital of Xi 'an Jiaotong University.Tyrosine kinase inhibitors (TKI) combined with chemotherapy and subsequent allogeneic hematopoietic stem cell transplantation (allo-HSCT) are routinely used in patients with philadelpha-positive lymphoblastic leukemia (Ph+ALL). However, TKI maintenance therapy post-HSCT remains controversial. In this study, Ph+ALL patients are enrolled and given dasatinib combined with chemotherapy followed by allo-HSCT. Then patients in the group A continuing to use dasatinib for 1 year is compared with those in the group B receiving dasatinib for 6 months after HSCT. The measurable residual disease (MRD), complete remission (CR), overall survival (OS), disease free survival (DFS), non-relapse mortality (NRM) and the incidence of graft versus host disease (GVHD) will be observed to determine the optimal duration of TKI maintenance therapy post-HSCT.", 'detailedDescription': 'About 25% of adult patients with acute lymphoblastic leukemia (ALL) are associated with t (9; 22), positive philadelphia chromosome (Ph+ ALL), in whom BCR/ABL fusion gene can be detected in the bone marrow and peripheral blood. Although current treatment strategies using tyrosine kinase inhibitors (TKIs) such as dasatinib combined with chemotherapy have achieved high complete remission (CR) rates, the duration of remission is short, and most Ph+ ALL patients relapse within 2 years. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) bridging to CR remains the only strategy to cure Ph+ ALL. However, TKI maintenance therapy post-HSCT remains controversial. In this study, Ph+ALL patients are enrolled. The participants will receive dasatinib combined with induction and consolidation chemotherapy to obtain molecular remission and then undergo allo-HSCT. After the above treatments, the patients will be randomly divided into two groups. The subjects in the group A will continue to use dasatinib for 1 year, while the patients in the group B receive dasatinib for 6 months post-HSCT. The measurable residual disease (MRD), CR, overall survival (OS), disease free survival (DFS), non-relapse mortality (NRM) and the incidence of graft versus host disease (GVHD) will be observed to determine the optimal duration of TKI maintenance therapy post-HSCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old, newly diagnosed as Ph+ALL.\n* Sign the informed consent.\n* Have appropriate allo-HSCT donors.\n* Accept allo-HSCT.\n* Accept follow-up.\n\nExclusion Criteria:\n\n* Liver and kidney function impairment: serum transaminase \\> 2 times of the upper limit of normal value, total bilirubin \\> 1.5 times of the upper limit of normal value, serum inosine \\> the upper limit of normal value (97 umol/L).\n* Active hepatitis B, hepatitis C or tuberculosis infection.\n* Can not tolerate the adverse effects of dasatinib.\n* Pregnancy.\n* Diagnosis of mental disorders.\n* Failed to reach molecular complete remission (MCR) after the early treatment.\n* Do not accept follow-up.'}, 'identificationModule': {'nctId': 'NCT05024357', 'briefTitle': 'A Study of TKI Maintenance Therapy Following Allo-HSCT in Newly Diagnosed Ph+ Adult ALL', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'A Randomized Controlled Study of Tyrosine Kinase Inhibitor Maintenance Therapy Following Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed Philadelphia Chromesome Positive Adult Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': 'XJTU1AF-CRF-2020-002-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dasatinib for 1 year', 'description': 'After the allo-HSCT treatment, the patients in this group will continue to take dasatinib orally for 1 year.', 'interventionNames': ['Drug: Dasatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Dasatinib for 6 months', 'description': 'After the allo-HSCT treatment, the patients in this group will receive dasatinib for 6 months.', 'interventionNames': ['Drug: Dasatinib']}], 'interventions': [{'name': 'Dasatinib', 'type': 'DRUG', 'otherNames': ['Dasatinib tablet'], 'description': 'Take Dasatinib orally for 1 year or 6 months post-HSCT.', 'armGroupLabels': ['Dasatinib for 1 year', 'Dasatinib for 6 months']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pengcheng He', 'role': 'CONTACT', 'email': 'hepc@163.com', 'phone': '0086-18991232609'}, {'name': 'Xiaoyan Zheng', 'role': 'CONTACT', 'email': 'xiaoy_2008@126.com', 'phone': '0086-15829370502'}, {'name': 'Xiaoning Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Huachao Zhu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Juan Ren', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ying Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ting Fan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Affiliated Hospital of Xian Jiaotong University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Pengcheng He', 'role': 'CONTACT', 'email': 'hepc@163.com', 'phone': '0086-18991232609'}, {'name': 'Xiaoyan Zheng', 'role': 'CONTACT', 'email': 'xiaoy_2008@126.com', 'phone': '0086-15829370502'}], 'overallOfficials': [{'name': 'Pengcheng He', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Xian Jiaotong University'}, {'name': 'Xiaoning Wang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Xian Jiaotong University'}, {'name': 'Huachao Zhu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Xian Jiaotong University'}, {'name': 'Juan Ren', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Xian Jiaotong University'}, {'name': 'Ying Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Xian Jiaotong University'}, {'name': 'Ting Fan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Xian Jiaotong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}