[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07053020":3,"trial-entities:NCT07053020":86,"trial-summary:NCT07053020":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":14,"eligibility_criteria":48,"std_ages":55,"locations":58,"central_contacts":76,"overall_officials":79,"references":81,"see_also_links":82},"NCT07053020","2024-1896","A Phase 1 Open-Label, Dose-Ranging Safety and Pharmacokinetics Study of Oral Cladribine in Patients With Acute Myeloid Leukemia (AML)","NOT_YET_RECRUITING","2030-06-30","2026-08","2026-08-25","2027-12-01","M.D. Anderson Cancer Center","OTHER",false,"The goal of Part 1 of this clinical research study is to find the highest tolerable dose of cladribine that can be given in combination with low dose cytarabine (LDAC) and venetoclax to patients who have AML.\n\nThe goal of Part 2 of this clinical research study is to learn if the dose of cladribine found in Part 1, when combined with LDAC and venetoclax, can help to control the disease.","Primary Objective:\n\nThe primary objective of Phase 1 is to determine safety and tolerability of oral cladribine in patients with AML and to identify a RP2D.\n\nSecondary Objective:\n\nThe secondary objectives of Phase 1 are to provide a qualitative assessment of systemic exposure based on plasma cladribine concentrations after administration of oral cladribine to patients with AML and to explore the activity of cladribine\u002FLDAC\u002Fvenetoclax in patients with relapsed or refractory AML.",[18],"Acute Myeloid Leukemia (AML)",[],"INTERVENTIONAL","TREATMENT",[23,24],"PHASE1","PHASE2",{"count":26,"type":27},58,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Cytarabine","Given by intravenous adminstration",[34],"Part 1\u002F2 Treatment with Oral Cladribine in Patients with Acute Myeloid Leukemia",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Oral Cladribine","Given Orally",[34],[40],{"measure":41,"description":42,"timeFrame":43},"Safety and Adverse Events (AEs)","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0","Through study completion; an average of 1 year",[],"ALL","18 Years",null,{"inclusion":49,"exclusion":53,"raw_text":54},[50,51,52],"Serum creatinine . 2.0xupper limit of normal (ULN)","Serum total bilirubin .2xULN (with the exception of patients with known Gilbert's syndrome: serum total bilirubin must be \\\u003C3xULN in these patients)","Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvic transaminase) .2.5xULN or .5xULN if due to leukemic involvement) 4. Adequate cardiac function with a left ventricular ejection fraction .50% 5. Female participants are eligible to enter and participate in the study if they are of nonchildbearing potential. Female participants of childbearing age must use at least 2 forms of effective birth control during the study treatment period and for at least 90 days after the last dose of investigational product. 6. Male participants are eligible to enter and participate in the study if they agree to use effective methods of contraception during the study treatment period and for at least 90 days after the last dose of investigational product.",[],"Inclusion Criteria:\n\n1. Provision of written informed consent prior to any study related procedures.\n2. Disease characteristics, defined as:\n\n   Part 1:\n\n   Dose-escalation cohorts: Patients with relapsed and\u002For refractory AML.\n\n   Part 2:\n\n   Cohort A: Patients aged .18 years with newly diagnosed ts-AML, defined as patients with prior diagnosis of MDS, treated with hypomethylating agents who have then progressed to AML. Prior therapy with hydroxyurea, hematopoietic growth factors, HMA, ATRA, or a total dose of cytarabine up to 2g (for emergency use for stabilization) is allowed.\n\n   Cohort B: Patients aged . 60 years with newly diagnosed AML with monocytic phenotype, defined as AML-M5 by FAB or flow cytometry, and\u002For patients . 60 years with newly diagnosed AML with RAS mutations. Patients aged \\\u003C 60 years who are unsuitable for standard induction therapy may be eligible after discussion with primary investigator.\n3. Adequate renal and hepatic organ function as indicated by the following laboratory values:\n\n   * Serum creatinine . 2.0xupper limit of normal (ULN)\n   * Serum total bilirubin .2xULN (with the exception of patients with known Gilbert's syndrome: serum total bilirubin must be \\\u003C3xULN in these patients)\n   * Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvic transaminase) .2.5xULN or .5xULN if due to leukemic involvement)\n4. Adequate cardiac function with a left ventricular ejection fraction .50%\n5. Female participants are eligible to enter and participate in the study if they are of nonchildbearing potential. Female participants of childbearing age must use at least 2 forms of effective birth control during the study treatment period and for at least 90 days after the last dose of investigational product.\n6. Male participants are eligible to enter and participate in the study if they agree to use effective methods of contraception during the study treatment period and for at least 90 days after the last dose of investigational product.\n\nExclusion Criteria:\n\n1. 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.\n2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the compounds in the study.\n3. Legal incapacity or limited legal capacity.\n4. Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation.\n5. Patients unwilling to comply with protocol requirements related to the assigned part.\n6. Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. 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 chemotherapy agents, breastfeeding should also be avoided.",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":60,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":73},"The University of Texas M. D. Anderson Cancer Center","Houston","Texas","77030","United States",[66,71],{"name":67,"role":68,"phone":69,"email":70},"Gautam Borthakur, MBBS","CONTACT","713-563-1586","gborthak@mdanderson.org",{"name":67,"role":72},"PRINCIPAL_INVESTIGATOR",{"lat":74,"lon":75},29.76328,-95.36327,[77],{"name":67,"role":68,"phone":78,"email":70},"(713) 563-1586",[80],{"name":67,"affiliation":12,"role":72},[],[83],{"label":84,"url":85},"MD Anderson Cancer Center Website","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Acute Myeloid Leukemia",[90],"RAS Family Oncogene",{"nct_id":4,"found":92,"summary":93,"prompt_version":103},true,{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an open-label study, meaning you and your doctors will know which treatments you are receiving. It is a dose-ranging study, starting with finding the right dose and then testing its effectiveness.","completed","Phase 1b\u002F2 Study of Oral Cladribine for Acute Myeloid Leukemia (AML)","This study is testing a new combination of medicines for Acute Myeloid Leukemia (AML), a type of blood cancer. It involves oral cladribine, cytarabine, and venetoclax. The first part of the study aims to find the safest and most effective dose of oral cladribine when given with these other drugs. The second part will then see if this dose helps control the disease in patients with newly diagnosed AML. You may be able to join if you are 18 or older and have relapsed (returned) or refractory (not responding to treatment) AML, or newly diagnosed AML after a prior diagnosis of Myelodysplastic Syndromes (MDS). The study is looking to enroll about 58 participants, but its current recruitment status is unclear.","Your safety and any side effects will be monitored throughout the study, which is expected to last an average of one year.",120,"Not specified in the trial record.","Not stated in the trial record.",[31,36],"v2"]