Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-26 @ 6:51 AM
Study NCT ID:
NCT01211457
Status:
UNKNOWN
Last Update Posted:
2019-07-16
First Post:
2010-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C117959', 'term': 'sapacitabine'}, {'id': 'D000077209', 'term': 'Decitabine'}, {'id': 'C579720', 'term': 'venetoclax'}], 'ancestors': [{'id': 'D001374', 'term': 'Azacitidine'}, {'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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2010-09-27', 'studyFirstSubmitQcDate': '2010-09-28', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'response duration', 'timeFrame': '2 years'}, {'measure': 'transfusion requirements', 'timeFrame': '2 years'}, {'measure': 'hospitalized days', 'timeFrame': '2 years'}, {'measure': 'overall survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sapacitabine', 'decitabine', 'venetoclax', 'elderly', 'AML', 'MDS', 'Refractory', 'relapsed', 'untreated'], 'conditions': ['Acute Myeloid Leukemia', 'Myelodysplastic Syndromes']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Pooled Analysis of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine Administered in Alternating Cycles. Farhad Ravandi, Tapan M. Kadia, Gautam Borthakur, William G. Wierda, Stuart L. Goldberg, Meir Wetzler, Parameswaran Venugopal, Karen Seiter, Judy Chiao and Hagop M. Kantarjian. Blood 2012 120:2630.'}]}, 'descriptionModule': {'briefSummary': 'This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS', 'detailedDescription': 'This is an open-label, single arm, study of sapacitabine administered in alternating cycles with decitabine in elderly patients with previously untreated AML (Part 1) or concomitantly with venetoclax in adult patients with relapsed or refractory AML or MDS (Part 2). Treatment will be administered on an outpatient basis. One treatment cycle is 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed AML based on WHO classification (Part 1) or previously treated AML or MDS (Part 2)\n* Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator (Part 1); age 18 years or older (Part 2)\n* ECOG performance status 0-2\n* Adequate renal function\n* Adequate liver function\n* Able to swallow capsules\n* Ability to understand and willingness to sign the informed consent form\n\nExclusion Criteria:\n\n* AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement\n* Known central nervous system (CNS) involvement by leukemia\n* Uncontrolled intercurrent illness including\n* Known hypersensitivity to decitabine (Part 1) or venetoclax (Part 2)\n* Known to be HIV-positive'}, 'identificationModule': {'nctId': 'NCT01211457', 'briefTitle': 'Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cyclacel Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia or Myelodysplastic Syndromes', 'orgStudyIdInfo': {'id': 'CYC682-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sapacitabine/decitabine (Part 1 - completed)', 'description': 'decitabine will be administered in alternating cycles with sapacitabine', 'interventionNames': ['Drug: sapacitabine and decitabine (Part 1 - completed)']}, {'type': 'EXPERIMENTAL', 'label': 'sapacitabine/venetoclax (Part 2 - recruiting)', 'description': 'sapacitabine will be administered concomitantly with venetoclax', 'interventionNames': ['Drug: sapacitabine and venetoclax (Part 2 - recruiting)']}], 'interventions': [{'name': 'sapacitabine and decitabine (Part 1 - completed)', 'type': 'DRUG', 'description': 'decitabine will be administered in alternating cycles with sapacitabine', 'armGroupLabels': ['Sapacitabine/decitabine (Part 1 - completed)']}, {'name': 'sapacitabine and venetoclax (Part 2 - recruiting)', 'type': 'DRUG', 'description': 'sapacitabine will be administered concomitantly with venetoclax', 'armGroupLabels': ['sapacitabine/venetoclax (Part 2 - recruiting)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '77030-3387', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debra Bull - Linderman, RN', 'role': 'CONTACT', 'email': 'DLBull@mdanderson.org', 'phone': '713-563-4303'}, {'name': 'Tapan M Kadia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Judy H Chiao, MD', 'role': 'CONTACT', 'email': 'jchiao@cyclacel.com', 'phone': '9085177330'}], 'overallOfficials': [{'name': 'Hagop M Kantarjian, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cyclacel Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}