{ "FullStudy":{ "Rank":217888, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515527", "OrgStudyIdInfo":{ "OrgStudyId":"2011-0987" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"NCI-2012-00145", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"NCI CTRP" } ] }, "Organization":{ "OrgFullName":"M.D. Anderson Cancer Center", "OrgClass":"OTHER" }, "BriefTitle":"Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)", "OfficialTitle":"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)" }, "StatusModule":{ "StatusVerifiedDate":"April 2020", "OverallStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 7, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 1, 2021", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"February 1, 2021", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"April 16, 2020", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 17, 2020", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"M.D. Anderson Cancer Center", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No", "IsFDARegulatedDrug":"Yes", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"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.", "DetailedDescription":"Study Drug Administration:\n\nIf you are eligible to take part in this study, you will receive 1 or 2 cycles of induction therapy followed by up to 17 cycles of consolidation therapy. Each study cycle is 4 weeks.\n\nInduction Cycles:\n\nOn Days 1-5, you will receive cladribine by vein over 1-2 hours.\n\nOn Days 1-10, you will give yourself the cytarabine by injection twice a day about 12 hours apart. You will receive instructions on how give yourself the injections.\n\nYou may receive up to 2 cycles at this dose and schedule.\n\nConsolidation Cycles:\n\nConsolidation cycles will begin on Cycle 2 regardless of how many cycles you received of induction therapy.\n\nDuring Cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18:\n\nOn Days 1-3, you will receive cladribine by vein over 1-2 hours.\nOn Days 1-10, you will give yourself cytarabine by injection twice daily starting 3 to 6 hours after the start of the cladribine infusion.\n\nCycles 3, 4, 7, 8, 11, 12, 15, and 16:\n\n°On Days 1-5, you will receive decitabine by vein over 1-2 hours each day.\n\nLength of Treatment:\n\nYou may continue taking the study drugs for up to 18 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.\n\nYour participation on the study will be over when you have completed follow-up.\n\nStudy Visits:\n\nOn Day 1 of every cycle:\n\nYou will have a physical exam, including measurement of your weight and vital signs.\nYour performance status will be recorded.\n\nOn Day 21 (+/- 7days) of the induction cycle, you may have a bone marrow aspirate to check the status of the disease. After that, you will have a bone marrow aspirate every 2 weeks (or more often if your doctor feels it is necessary). If your routine blood tests show that there is still leukemia, you may not need to have the bone marrow samples collected.\n\nBlood (about 1-2 teaspoons) will be drawn for routine tests at least 1 time weekly until remission, then every 2-4 weeks during treatment, the every 4-8 weeks while you are on the study.\n\nFollow-Up Visits:\n\nWhen you are off treatment, every 6 -12 months you will be contacted by a member of the study staff. You will be asked about any side effects you may be having. The phone calls will take about 5-10 minutes. You will continue to be called for as long as possible." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Leukemia" ] }, "KeywordList":{ "Keyword":[ "Leukemia", "Acute myeloid leukemia", "AML", "myelodysplastic syndrome", "MDS", "Cytarabine", "Ara-C", "Cytosar", "DepoCyt", "Cytosine Arabinosine Hydrochloride", "Decitabine", "Dacogen", "Cladribine", "Leustatin", "2-CdA" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"160", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Cladribine + Cytarabine Alt. with Decitabine", "ArmGroupType":"Experimental", "ArmGroupDescription":"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.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Cladribine", "Drug: Cytarabine", "Drug: Decitabine" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Cladribine", "InterventionDescription":"Induction cycle: 5 mg/m2 by vein on days 1 - 5 for up to 2, 28 day cycles.\n\nConsolidation cycle: 5 mg/m2 by vein on days 1 - 3 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Cladribine + Cytarabine Alt. with Decitabine" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Leustatin", "2-CdA" ] } },{ "InterventionType":"Drug", "InterventionName":"Cytarabine", "InterventionDescription":"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.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Cladribine + Cytarabine Alt. with Decitabine" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Ara-C", "Cytosar DepoCyt", "Cytosine Arabinosine Hydrochloride" ] } },{ "InterventionType":"Drug", "InterventionName":"Decitabine", "InterventionDescription":"Consolidation cycle: 20 mg/m2 by vein over 1 to 2 hours on days 1-5 of cycles 3, 4, 7, 8, 11, 12, 15, and 16.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Cladribine + Cytarabine Alt. with Decitabine" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Dacogen" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Disease-Free Survival (DFS)", "PrimaryOutcomeDescription":"Disease-free survival (DFS) defined as the time interval from treatment start until clinically significant disease progression or death, whichever occurred first. Participants followed for survival every 6 to 12 months after completion of active treatment. Study continuously monitored for primary endpoint, DFS using the method of Thall, Wooten, and Tannir.", "PrimaryOutcomeTimeFrame":"Day 21" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with previously untreated AML or high risk MDS (>/= 10 % blasts or IPSS >/= intermediate-2). Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, ATRA, or an isolated 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.\nAge >/= 60 years. Patients aged < 60 years who are unsuitable for standard induction therapy may be eligible after discussion with PI\nAdequate organ function as defined below: liver function (bilirubin