[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06240754":3,"trial-entities:NCT06240754":113,"trial-summary:NCT06240754":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":37,"secondary_outcomes":42,"sex":54,"minimum_age":55,"maximum_age":17,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":84,"locations":87,"central_contacts":104,"overall_officials":106,"references":108,"see_also_links":109},"NCT06240754","202405007","Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial","A Pilot Study of Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2: A Decentralized Trial","RECRUITING","2029-06-30","2026-08","2026-08-10","2024-10-10","Washington University School of Medicine","OTHER",true,"Study researchers think that a drug called enasidenib may help people with clonal cytopenia of undetermined significance (CCUS) because the drug blocks the mutated IDH2 protein, which may improve blood cell counts. The purpose of this study is to find out whether enasidenib is a safe and effective treatment for CCUS.",null,[19,20],"Clonal Cytopenia of Undetermined Significance","CCUS Clonal Cytopenia of Undetermined Significance",[19,22,23,24],"CCUS","IDH2","Enasidenib","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},15,"ESTIMATED",[33],{"type":34,"name":24,"description":35,"armGroupLabels":36},"DRUG","Provided by BMS.",[24],[38],{"measure":39,"description":40,"timeFrame":41},"Best hematologic response","Hematologic response to enasidenib will be evaluated according to a modified version of the IWG 2006 Criteria for Hematologic Improvement for patients with MDS on clinical trials","Up to 18 cycles (each cycle is 28 days) of treatment (up to approximately 17 months)",[43,47,51],{"measure":44,"description":45,"timeFrame":46},"Toxicity as measured by the number of adverse events experienced by participant","Measured by CTCAE v 5.0","From start of treatment through 30 days after the last day of treatment (up to approximately 18 months)",{"measure":48,"description":49,"timeFrame":50},"Change in mutant IDH2 variant allele fraction","The IDH2 variant allele fraction reflects the clonal dominance in the blood. Blood samples will be drawn at various time points throughout the study to determine the IDH2 variant allele fraction. The lower the IDH2 variant allele fraction the better the outcome.","Baseline, day 1 of cycles 3\u002F6\u002F9\u002F12\u002F15 (each cycle is 28 days), and end of treatment (up to approximately 17 months)",{"measure":52,"timeFrame":53},"Duration of hematologic improvement","From start of treatment through completion of treatment (estimated to be 17 months)","ALL","18 Years",false,{"inclusion":58,"exclusion":72,"raw_text":83},[59,60,61,62,63,64,65,66,67,68,69,70,71],"Unexplained cytopenia for at least 6 months. Cytopenia is defined as the presence of ≥1 blood count indexes below the following thresholds:","Hgb \\\u003C10 g\u002FdL","ANC \\\u003C1.8 × 109\u002FL","Platelets \\\u003C100 × 109\u002FL","IDH2 gene mutation (R140 or R172), performed locally, at a frequency ≥ 2%.","At least 18 years of age.","ECOG performance status 0-2","Adequate organ function as defined below:","AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN","Serum total bilirubin \\\u003C 1.5 x IULN (un upper limit of bilirubin 5 mg\u002FdL is acceptable if it can be attributed to Gilbert's syndrome or erythropoiesis)","Creatinine clearance \\> 50 mL\u002Fmin by Cockcroft-Gault glomerular filtration rate estimation or serum creatinine ≤ 2 x IULN","The effects of enasidenib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 24 months after the last dose of enasidenib. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and for 4 months after the last dose of enasidenib.","Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.",[73,74,75,76,77,78,79,80,81,82],"Indication of hematologic disease by bone marrow biopsy within 6 months of study entry.","Evidence of disease progression from time of bone marrow biopsy to enrollment based on investigator review of symptoms and complete blood counts","Active malignancy (defined as \\> 1 cm disease on most recent CT scan in the past 6 months).","Currently receiving therapy for solid tumor malignancy or received within the last 6 months.","Currently receiving any other investigational agents.","Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.","A history of allergic reactions attributed to compounds of similar chemical or biologic composition to enasidenib or other agents used in the study.","Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.","Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 72 hours of study entry.","Positive direct Coombs test.","Inclusion Criteria:\n\n* Unexplained cytopenia for at least 6 months. Cytopenia is defined as the presence of ≥1 blood count indexes below the following thresholds:\n\n  * Hgb \\\u003C10 g\u002FdL\n  * ANC \\\u003C1.8 × 109\u002FL\n  * Platelets \\\u003C100 × 109\u002FL\n* IDH2 gene mutation (R140 or R172), performed locally, at a frequency ≥ 2%.\n* At least 18 years of age.\n* ECOG performance status 0-2\n* Adequate organ function as defined below:\n\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Serum total bilirubin \\\u003C 1.5 x IULN (un upper limit of bilirubin 5 mg\u002FdL is acceptable if it can be attributed to Gilbert's syndrome or erythropoiesis)\n  * Creatinine clearance \\> 50 mL\u002Fmin by Cockcroft-Gault glomerular filtration rate estimation or serum creatinine ≤ 2 x IULN\n* The effects of enasidenib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 24 months after the last dose of enasidenib. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and for 4 months after the last dose of enasidenib.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Indication of hematologic disease by bone marrow biopsy within 6 months of study entry.\n\n  * Evidence of disease progression from time of bone marrow biopsy to enrollment based on investigator review of symptoms and complete blood counts\n* Active malignancy (defined as \\> 1 cm disease on most recent CT scan in the past 6 months).\n* Currently receiving therapy for solid tumor malignancy or received within the last 6 months.\n* Currently receiving any other investigational agents.\n* Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to enasidenib or other agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 72 hours of study entry.\n* Positive direct Coombs test.",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":13,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":101},"St Louis","Missouri","63110","United States",[94,99],{"name":95,"role":96,"phone":97,"email":98},"Giulia Petrone, M.D.","CONTACT","314-362-6826","gpetrone@wustl.edu",{"name":95,"role":100},"PRINCIPAL_INVESTIGATOR",{"lat":102,"lon":103},38.62727,-90.19789,[105],{"name":95,"role":96,"phone":97,"email":98},[107],{"name":95,"affiliation":13,"role":100},[],[110],{"label":111,"url":112},"Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine","http:\u002F\u002Fwww.siteman.wustl.edu",{"nct_id":4,"conditions":114,"biomarkers":115},[19],[116],"IDH2 Gene",{"nct_id":4,"found":15,"summary":118,"prompt_version":128},{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This is an interventional study, meaning participants will receive a specific treatment. It is designed to enroll about 15 participants.","completed","Enasidenib for Clonal Cytopenia of Undetermined Significance with IDH2 Mutation","This study is looking into whether enasidenib is a safe and effective treatment for people with clonal cytopenia of undetermined significance (CCUS). CCUS is a condition where you have low blood cell counts (cytopenia) for at least six months without a clear cause. Researchers believe enasidenib may help because it blocks a specific mutated protein called IDH2, which could improve blood cell counts. To join, you must be at least 18 years old, have unexplained low blood counts, and have a specific IDH2 gene mutation. The main goal is to see if enasidenib improves your blood counts over approximately 17 months. This study is currently recruiting about 15 participants.","The primary endpoint measures best hematologic response for up to approximately 17 months.",109,"Participants will receive enasidenib for up to 18 cycles, with each cycle lasting 28 days, for a total of approximately 17 months.","Not stated in the trial record.",[24],"v2"]