[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100172212":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":64,"collaborators":47,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":47,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":47,"enrollmentInfo":75,"targetDuration":47,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":52,"whyStopped":47,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cladribine + Cytarabine Alt. with Decitabine","EXPERIMENTAL","Induction cycle: Cladribine intravenous (IV) over approximately 1 to 2 hours, daily on days 1-5 combined with Cytarabine subcutaneous (SQ) twice daily on days 1-10. Cytarabine should be administered approximately 3-6 hours following the start of the cladribine infusion.\n\nConsolidation cycle: Cladribine IV over 1 to 2 hours, daily on days 1-3 combined with Cytarabine SQ twice daily on days 1-10. Cytarabine should be administered 3-6 hours following the start of the cladribine infusion.\n\nAlternating with: Decitabine IV over 1 to 2 hours, daily on days 1-5.",[13,14,15],"Drug: Cladribine","Drug: Cytarabine","Drug: Decitabine",[17,25,33],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Cladribine","Induction cycle: 5 mg\u002Fm2 by vein on days 1 - 5 for up to 2, 28 day cycles.\n\nConsolidation cycle: 5 mg\u002Fm2 by vein on days 1 - 3 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18.",[9],[23,24],"Leustatin","2-CdA",{"type":18,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Cytarabine","Induction cycle: 20 mg subcutaneously twice daily on days 1-10 for up to 2, 28 day cycles.\n\nConsolidation cycle: 20 mg subcutaneously twice daily on days 1 - 10 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18.",[9],[30,31,32],"Ara-C","Cytosar DepoCyt","Cytosine Arabinosine Hydrochloride",{"type":18,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Decitabine","Consolidation cycle: 20 mg\u002Fm2 by vein over 1 to 2 hours on days 1-5 of cycles 3, 4, 7, 8, 11, 12, 15, and 16.",[9],[38],"Dacogen",[40],{"name":41,"affiliation":5,"role":42},"Tapan Kadia, MD","PRINCIPAL_INVESTIGATOR",[44],{"name":41,"role":45,"phone":46,"phoneExt":47,"email":48},"CONTACT","713-563-3534",null,"tkadia@mdanderson.org",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":47},"University of Texas MD Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-95.36327,29.76328,{"lat":62,"lon":61},{"type":65,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100172212","phase-2-cladribine-plus-low-dose-cytarabine-ldac-alternating-with-decitabine-in-patients-with-acute-myeloid-leukemia-aml-or-high-risk-myelodysplastic-syndrome-mds-100172212",false,"NCT01515527","Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)","Phase II Study of Cladribine Plus Low Dose Cytarabine (LDAC) Induction Followed By Consolidation With Cladribine Plus LDAC Alternating With Decitabine in Patients With Untreated Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)","Cohort 1\n\nInclusion Criteria:\n\n1. Patients with previously untreated AML or high risk MDS (\\>\u002F= 10 % blasts or IPSS \\>\u002F= intermediate-2). Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, ATRA, or total dose of cytarabine up to 2g is allowed. Patients with history of MDS transformed to AML are eligible regardless of their prior therapy for MDS provided this will be their first induction therapy for AML.\n2. Age \\>\u002F= 60 years. Patients aged \\\u003C 60 years who are unsuitable for standard induction therapy may be eligible after discussion with PI\n3. Adequate organ function as defined below:\n\n   * liver function (bilirubin \\\u003C 2mg\u002FdL, AST and\u002For ALT \\\u003C3 x ULN)\n   * kidney function (creatinine \\\u003C 1.5 x ULN ).\n4. ECOG performance status of ≤ 2.\n5. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol.\n7. Prior therapy with decitabine will be allowed unless the patient experienced progression to AML while being treated with decitabine.\n\nExclusion Criteria:\n\n1. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.\n2. Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n3. Patient with documented hypersensitivity to any of the components of the chemotherapy program.\n4. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.\n\nCohort 2\n\nInclusion Criteria:\n\n8\\. Patients with previously untreated AML who are not currently eligible for other frontline clinical trials of AML therapy. Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, ATRA, or total dose of cytarabine up to 2g is allowed. Patients with history of MDS transformed to AML are eligible regardless of their prior therapy for MDS provided this will be their first induction therapy for AML.\n\n9\\. Age \\>\u002F= 18 years who are unsuitable for standard induction therapy are eligible after discussion with PI 10. Patients must have one of the following:\n\n* Creatinine \\>\u002F= 2 mg\u002FdL\n* Total bilirubin \\>\u002F= 2 mg\u002FdL\n* ECOG Performance Status equal to 3 or 4\n* Is ineligible for participation in a protocol of higher priority 11. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n\n  12\\. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol.\n\n  13\\. Prior therapy with decitabine will be allowed unless the patient experienced progression to AML while being treated with decitabine.\n\nExclusion Criteria:\n\n5\\. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.\n\n6\\. Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, unless these illnesses are judged to be related to the underlying leukemia.\n\n7\\. Patient with documented hypersensitivity to any of the components of the chemotherapy program.\n\n8\\. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.\n\nCohort 3\n\nInclusion Criteria:\n\n1. Patients with relapsed and or refractory AML who have received at least one prior therapy for their AML.\n2. Age \\>\u002F= 18 years.\n3. Adequate organ function as defined below:\n\n   * liver function (bilirubin \\\u003C 2mg\u002FdL, AST and\u002For ALT \\\u003C3 x ULN)\n   * kidney function (creatinine \\\u003C 1.5 x ULN ).\n4. ECOG performance status of ≤ 2.\n5. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol.\n7. Prior therapy with venetoclax will be allowed.\n\n   Exclusion Criteria\n8. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.\n9. Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n10. Patient with documented hypersensitivity to any of the components of the chemotherapy program.\n\nMen and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation","ALL","60 Years",{"count":76,"type":77},160,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","The goal of this clinical research study is to learn if cladribine given in combination with low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML or MDS. The safety of this drug combination will also be studied.\n\nCladribine is designed to interfere with the cell's ability to process DNA (the genetic material of cells). It can also insert itself into the DNA of cancer cells to stop them from growing and repairing themselves.\n\nCytarabine is designed to insert itself into DNA of cancer cells to stop them from growing and repairing themselves.\n\nDecitabine is designed to damage the DNA of cells, which may cause cancer cells to die.\n\nThis is an investigational study. Cladribine is FDA approved and commercially available for use in patients with hairy cell leukemia. Its use in patients with AML is investigational.\n\nCytarabine is FDA approved and commercially available for use in patients with AML.\n\nDecitabine is FDA approved and commercially available for use in patients with MDS. Its use for patients with AML is investigational.\n\nUp to 160 patients will take part in this study. All will be enrolled at MD Anderson.",[83],"Leukemia",[83,85,86,87,88,26,30,89,90,32,34,38,19,23,24],"Acute myeloid leukemia","AML","myelodysplastic syndrome","MDS","Cytosar","DepoCyt","2026-07-15",{"date":93,"type":94},"2026-07-16","ACTUAL",{"date":96,"type":94},"2012-02-07",{"date":98,"type":77},"2028-02-01",{"name":5,"class":6},1]