Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2026-03-05 @ 6:04 PM
Study NCT ID:
NCT03850418
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2019-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of increase or stable donor chimerism', 'timeFrame': 'one year', 'description': 'To determine the rate of increase or stable donor chimerism when using low dose azacitidine post allogenic stem cell transplant (SCT) in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) and myeloproliferative neoplasms (MPN) with documented low or decreasing donor chimerism'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myeloid Malignancy']}, 'descriptionModule': {'briefSummary': 'Previous studies provide a rationale for administration of AZA after allo SCT for decreasing chimerism. The investigators hypothesize that azacitidine can be well tolerated after SCT and help decrease rate of decreasing donor chimerism and hence decrease relapse without increasing GVHD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with AML/MDS/MPN, CMML post Allogeneic SCT who experience any drop in total or myeloid chimerism any time after day 30, or their day 30 or day100 myeloid donor chimerism is below 98% without concurrent hematologic relapse (that is, patients with \\<5% bone marrow blasts as obtained at that time point) will be offered treatment with azacitidine\n2. \\>=30 -180 days post SCT and patients must have ANC\\> 1000, PLT \\> 50,000\n3. Age 18-75 years old\n4. Performance score of at least 70% by Karnofsky\n5. Adequate kidney and liver function as demonstrated by:\n\n 1. Creatinine clearance should be \\>60 ml/min\n 2. Total Bilirubin \\<1.5, ALT/AST/Alk Phos \\< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.\n6. Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.\n7. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.\n8. Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment\n\nExclusion Criteria:\n\n1. Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause\n2. Active or prior CNS leukemia, unless in complete remission for at least 2 months.\n3. History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.\n4. Uncontrolled infection\n5. Grade III, IV graft versus host disease (GVHD"}, 'identificationModule': {'nctId': 'NCT03850418', 'briefTitle': 'Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant', 'orgStudyIdInfo': {'id': '12592'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZA', 'description': 'azacitidine', 'interventionNames': ['Drug: azacitidine']}], 'interventions': [{'name': 'azacitidine', 'type': 'DRUG', 'description': 'azacitidine 32mg/m2 x 5 days every 28 days for minimum of 4 cycles if tolerated', 'armGroupLabels': ['AZA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'shatha farhan', 'role': 'CONTACT', 'phone': '313-916-5002'}], 'facility': 'Henry ford hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'centralContacts': [{'name': 'shatha farhan, MD', 'role': 'CONTACT', 'email': 'SFARHAN1@HFHS.ORG', 'phone': '313 916 5002'}, {'name': 'NALINI JANAKIRAMAN, MD', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shatha Farhan', 'investigatorAffiliation': 'Henry Ford Health System'}}}}