Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-25 @ 12:42 PM
Study NCT ID:
NCT04505995
Status:
UNKNOWN
Last Update Posted:
2020-08-10
First Post:
2020-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Azacitidine and Homoharringtonine in JMML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D000077863', 'term': 'Homoharringtonine'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D006248', 'term': 'Harringtonines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-06', 'studyFirstSubmitDate': '2020-08-06', 'studyFirstSubmitQcDate': '2020-08-06', 'lastUpdatePostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Juvenile Myelomonocytic Leukemia (JMML) response rate at end of 4 Months', 'timeFrame': 'Up to 4 Months', 'description': 'Defined as proportion of patients with sustained clinical complete remission \\[cCR\\] or clinical partial remission \\[cPR\\] according to the International JMML response criteria in Niemeyer 2014 at 3 months (28 days cycles). Response must be sustained for at least 4 weeks either in the 4-week period preceding or succeeding 3 months (ie, sustained over the period minimum 2 months to end of 3 months, or end of 3 months to end of 4 months).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['JMML']}, 'descriptionModule': {'briefSummary': 'Juvenile myelomonocytic leukemia (JMML) has a poor prognosis in general, with hematopoietic stem cell transplant (HSCT) remaining the standard of care for cure. Azacitidine and homoharringtonine, which exhibited a anticancer mechanism and has been widely used in patients with relapse/refractory acute myeloid leukemia (AML). However, the efficacy of these agents has not been elucidated in children with JMML. The primary objective is to assess the treatment effect on response rate in this subject population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed JMML, with PB and BM confirming diagnosis prior to informed consent signature, with one of the following:\n\n 1. somatic mutation in PTPN11\n 2. somatic mutation in KRAS\n 3. somatic mutation in NRAS and HbF % \\> 5x normal value for age\n 4. clinical diagnosis of neurofibromatosis Type 1.\n\nExclusion Criteria:\n\n* 1\\. Any condition that would prevent the subject from participating in the study.\n\n 2\\. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if participated in the study.\n\n 3\\. Any condition that confounds the ability to interpret data from the study.'}, 'identificationModule': {'nctId': 'NCT04505995', 'briefTitle': 'Azacitidine and Homoharringtonine in JMML', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Efficacy of Concomitant Use of Azacitidine and Homoharringtonine in Children With Juvenile Myelomonocytic Leukemia', 'orgStudyIdInfo': {'id': 'JMML-CAMS-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Drug: Azacitidine and homoharringtonine']}], 'interventions': [{'name': 'Azacitidine and homoharringtonine', 'type': 'DRUG', 'description': 'Concommitant use of azacitidine and homoharringtonine', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao-Fan Zhu, M.D.', 'role': 'CONTACT', 'email': 'xfzhu@ihcams.ac.cn', 'phone': '+86-22-23909001'}], 'facility': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Wen-Yu Yang, M.D.', 'role': 'CONTACT', 'email': 'yangwenyu@ihcams.ac.cn', 'phone': '+86-22-23909138'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Taian City Central Hospital', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, {'name': 'The Second Hospital of Hebei Medical University', 'class': 'OTHER'}, {'name': "Children's Hospital of Hebei Province", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Lipeng Liu', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}