Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT06955858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-02
First Post:
2025-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of rhTPO in Hematopoietic Stem Cell Mobilization for Autologous Transplantation in Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total CD34+ cell count', 'timeFrame': 'two weeks', 'description': 'Median total number of CD34+ cells collected'}], 'secondaryOutcomes': [{'measure': 'the proportion of patients collecting more than or equal to 2*10^6 CD34+ cells/kg', 'timeFrame': 'two weeks'}, {'measure': 'the proportion of patients collecting more than or equal to 5*10^6 CD34+ cells/kg', 'timeFrame': 'two weeks'}, {'measure': 'total mononuclear cell count', 'timeFrame': 'two weeks', 'description': 'Median total number of mononuclear cells collected'}, {'measure': 'time of platelet engraftment', 'timeFrame': 'eight weeks', 'description': 'defined as platelet count \\>20×109 platelets/L for seven consecutive days without platelet transfusion'}, {'measure': 'time of neutrophil engraftment', 'timeFrame': 'four weeks', 'description': 'defined as the absolute value of neutrophils \\>0.5×109 cells/L for three consecutive days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recombinant Human Thrombopoietin'], 'conditions': ['Hematopoietic Stem Cell Mobilization']}, 'descriptionModule': {'briefSummary': 'Evaluation of the efficacy and safety of recombinant human thrombopoietin (rhTPO) at 300 U/kg/day for hematopoietic stem cell mobilization in autologous transplantation among acute leukemia patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18～65 years, regardless of gender.\n2. Histopathologically confirmed acute leukemia with immunohistochemical validation\n3. Sustained complete hematologic remission with documented minimal residual disease (MRD) negativity.\n4. Eastern Cooperative Oncology Group (ECOG) performance status smaller than 2 and a life expectancy of more than 6 months\n5. No active infectious disease; no severe organ failure.\n6. Willingness to participate with written informed consent for study enrollment.\n\nExclusion Criteria:\n\n1. Liver dysfunction (alanine aminotransferase or bilirubin greater than two times the normal upper limit).\n2. Renal dysfunction (creatinine or urea higher than 1.5 times the normal upper limit).\n3. Any disease that could put patients at high risk, including but not limited to unstable cardiac disease, uncontrolled atrial fibrillation or hypertension, severe diabetic retinopathy\n4. rhTPO aller- gies.\n5. Severe prior thrombosis-event.\n6. History of other malignancy, unless cured for more than 3 years\n7. Pregnant or lactating women\n8. Severe infectious disease (uncured tuberculosis, pulmonary aspergillosis)\n9. Epilepsia, dementia or any mental disease requiring treatment.\n10. Other conditions deemed inappropriate for study participation by the investigator.'}, 'identificationModule': {'nctId': 'NCT06955858', 'briefTitle': 'Clinical Study of rhTPO in Hematopoietic Stem Cell Mobilization for Autologous Transplantation in Acute Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'Recombinant Human Thrombopoietin for Autologous Hematopoietic Stem Cell Mobilization in Acute Leukemia: A Single-Arm Prospective Study', 'orgStudyIdInfo': {'id': 'IIT2025002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The group of rhTPO', 'interventionNames': ['Drug: Recombinant Human Thrombopoietin（rhTPO）']}], 'interventions': [{'name': 'Recombinant Human Thrombopoietin（rhTPO）', 'type': 'DRUG', 'description': 'G-CSF will be administered at a dose of 10 μg/kg/day subcutaneously for 7-10 days post-chemotherapy.\n\nrhTPO is started on the same day as G-CSF at 300 U/kg/d and injected subcutaneously until the stem cell collection was completed.', 'armGroupLabels': ['The group of rhTPO']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'country': 'China', 'facility': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}