[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT01409161":3,"trial-entities:NCT01409161":189,"trial-summary:NCT01409161":194},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":96,"secondary_outcomes":101,"sex":102,"minimum_age":103,"maximum_age":104,"healthy_volunteers":15,"eligibility_criteria":105,"std_ages":118,"locations":122,"central_contacts":176,"overall_officials":179,"references":181,"see_also_links":186},"NCT01409161","2010-0981","Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia","Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)","RECRUITING","2027-12-18","2026-05","2026-05-20","2011-10-05","M.D. Anderson Cancer Center","OTHER",false,"This phase II trial studies how well tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin works in treating patients with previously untreated acute promyelocytic leukemia. Drugs used in chemotherapy, such as tretinoin and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotoxins, such as gemtuzumab ozogamicin, may find certain cancer cells and kill them without harming normal cells. Giving tretinoin and arsenic trioxide together with gemtuzumab ozogamicin may kill more cancer cells.","PRIMARY OBJECTIVES:\n\nI. Assess whether a combination of all-trans retinoic acid (ATRA \\[tretinoin\\]), and arsenic trioxide (ATO) can produce long-term event-free survival in patients with low-risk untreated acute promyelocytic leukemia (APL).\n\nII. Assess whether administration of gemtuzumab ozogamicin (GO) at the diagnosis in patients with high-risk APL (white blood cell \\[WBC\\] \\> 10,000) and if the WBC rises to \\> 10,000 after start of treatment (in patients with low-risk disease) will improve complete response (CR) rate without increasing toxicity in high-risk untreated APL.\n\nOUTLINE:\n\nINDUCTION: Patients receive tretinoin orally (PO) twice daily (BID), arsenic trioxide intravenously (IV) over 1-2 hours daily, and gemtuzumab ozogamicin IV over 2 hours once at weeks 1-4.\n\nCONSOLIDATION: Patients achieving CR receive arsenic trioxide IV 5 days per week during weeks 1-4, 9-12, 17-20, and 25-28 and tretinoin PO BID for 2 weeks on and 2 weeks off. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 6-12 months.",[19],"Acute Promyelocytic Leukemia With PML-RARA",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},151,"ESTIMATED",[29,43,54,58],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Arsenic Trioxide","Given IV",[34],"Treatment (tretinoin, arsenic trioxide, gemtuzumab ozogamicin)",[36,37,38,39,40,41,42],"Arsenic (III) Oxide","Arsenic Sesquioxide","Arsenous Acid","Arsenous Acid Anhydride","Arsenous Oxide","Trisenox","White Arsenic",{"type":30,"name":44,"description":32,"armGroupLabels":45,"otherNames":46},"Gemtuzumab Ozogamicin",[34],[47,48,49,50,51,52,53],"Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody","CDP-771","CMA-676","gemtuzumab","hP67.6-Calicheamicin","Mylotarg","WAY-CMA-676",{"type":14,"name":55,"description":56,"armGroupLabels":57},"Laboratory Biomarker Analysis","Correlative studies",[34],{"type":30,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Tretinoin","Given PO",[34],[63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95],"2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-","Aberel","Airol","Aknoten","all trans-Retinoic acid","All-trans Retinoic Acid","All-trans Vitamin A Acid","all-trans-Retinoic acid","all-trans-Vitamin A acid","ATRA","Avita","beta-Retinoic Acid","Cordes Vas","Dermairol","Epi-Aberel","Eudyna","Renova","Retin-A","Retin-A MICRO","Retin-A-Micro","retinoic acid","Retisol-A","Ro 5488","Stieva-A","Stieva-A Forte","Trans Retinoic Acid","Trans Vitamin A Acid","trans-Retinoic acid","Tretinoinum","Vesanoid","vitamin A acid","Vitamin A acid, all-trans-","Vitinoin",[97],{"measure":98,"description":99,"timeFrame":100},"Event free survival","Monitored using a Bayesian time-to-event model.","The time from the start of treatment to first documentation of disease relapse or death, assessed up to 2 years",[],"ALL","10 Years",null,{"inclusion":106,"exclusion":112,"raw_text":117},[107,108,109,110,111],"A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test","Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of the study","Patients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and\u002For one dose of idarubicin due to the urgency to start therapy early)","Women of child-bearing potential must have a negative serum pregnancy test at screening; in addition to having a negative pregnancy test confirmed at screening, all female participants of childbearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug","All sexually active subjects (males and females of child-bearing potential) agree to use 2 effective methods of contraception for the duration of the study",[113,114,115,116],"Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than 480 milliseconds","Patients with creatinine \\> 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease","Patients with total bilirubin \\>= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease","Patients with alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\> 3 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease","Inclusion Criteria:\n\n* A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test\n* Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of the study\n* Patients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and\u002For one dose of idarubicin due to the urgency to start therapy early)\n* Women of child-bearing potential must have a negative serum pregnancy test at screening; in addition to having a negative pregnancy test confirmed at screening, all female participants of childbearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug\n* All sexually active subjects (males and females of child-bearing potential) agree to use 2 effective methods of contraception for the duration of the study\n\nExclusion Criteria:\n\n* Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than 480 milliseconds\n* Patients with creatinine \\> 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease\n* Patients with total bilirubin \\>= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease\n* Patients with alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\> 3 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease",[119,120,121],"CHILD","ADULT","OLDER_ADULT",[123,139,146,156,166],{"facility":124,"status":8,"city":125,"state":126,"zip":127,"country":128,"contacts":129,"geoPoint":136},"M D Anderson Cancer Center","Houston","Texas","77030","United States",[130,134],{"name":131,"role":132,"phone":133},"Farhad Ravandi-Kashani","CONTACT","713-745-0394",{"name":131,"role":135},"PRINCIPAL_INVESTIGATOR",{"lat":137,"lon":138},29.76328,-95.36327,{"facility":140,"status":8,"city":125,"state":126,"zip":141,"country":128,"contacts":142,"geoPoint":145},"MD Anderson Regional Care Center-Katy","77094",[143,144],{"name":131,"role":132,"phone":133},{"name":131,"role":135},{"lat":137,"lon":138},{"facility":147,"status":8,"city":148,"state":126,"zip":149,"country":128,"contacts":150,"geoPoint":153},"MD Anderson Regional Care Center-Bay Area","Nassau Bay","77058",[151,152],{"name":131,"role":132,"phone":133},{"name":131,"role":135},{"lat":154,"lon":155},29.54468,-95.09104,{"facility":157,"status":8,"city":158,"state":126,"zip":159,"country":128,"contacts":160,"geoPoint":163},"MD Anderson Regional Care Center-Sugar Land","Sugar Land","77478",[161,162],{"name":131,"role":132,"phone":133},{"name":131,"role":135},{"lat":164,"lon":165},29.61968,-95.63495,{"facility":167,"status":8,"city":168,"state":126,"zip":169,"country":128,"contacts":170,"geoPoint":173},"MD Anderson Regional Care Center-The Woodlands","The Woodlands","77384",[171,172],{"name":131,"role":132,"phone":133},{"name":131,"role":135},{"lat":174,"lon":175},30.15799,-95.48938,[177],{"name":131,"role":132,"phone":133,"email":178},"fravandi@mdanderson.org",[180],{"name":131,"affiliation":13,"role":135},[182],{"pmid":183,"type":184,"citation":185},"39584789","DERIVED","Jen WY, Marvin-Peek J, Kantarjian HM, Alvarado Y, Borthakur G, Jabbour E, Wierda W, Kadia TM, Daver NG, DiNardo CD, Short NJ, Jain N, Ferrajoli A, Kornblau S, Yilmaz M, Ohanian M, McCue D, Burger J, Hammond D, Patel K, Issa GC, Pemmaraju N, Sasaki K, Maiti A, Abbas HA, Chien K, Takahashi K, Haddad F, Bose P, Masarova L, Montalban-Bravo G, Swaminathan M, Brandt M, Pierce S, Garcia-Manero G, Ravandi F. Long-term follow-up of a phase 2 study of all-trans retinoic acid, arsenic trioxide, and gemtuzumab ozogamicin in acute promyelocytic leukemia. Cancer. 2025 Jan 1;131(1):e35662. doi: 10.1002\u002Fcncr.35662. Epub 2024 Nov 25.",[187],{"label":124,"url":188},"http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":190,"biomarkers":192},[191],"Acute Promyelocytic Leukemia",[193],"PML\u002FRARA Fusion Gene",{"nct_id":4,"found":195,"summary":196,"prompt_version":206},true,{"design":197,"status":198,"heading":199,"summary":200,"follow_up":201,"word_count":202,"commitments":203,"compensation":204,"drugs_mentioned":205},"This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 151 participants.","completed","Tretinoin and Arsenic Trioxide for Acute Promyelocytic Leukemia","This study is looking at how well a combination of drugs works for people with newly diagnosed acute promyelocytic leukemia (APL). The drugs being tested are tretinoin (a form of vitamin A), arsenic trioxide, and gemtuzumab ozogamicin. Tretinoin and arsenic trioxide are chemotherapy drugs that stop cancer cells from growing. Gemtuzumab ozogamicin is an immunotoxin that targets and kills cancer cells. Researchers want to see if adding gemtuzumab ozogamicin to tretinoin and arsenic trioxide can kill more cancer cells. To join, you must have an APL diagnosis confirmed by a specific genetic test (PML-RAR-alpha fusion gene). The main goal is to see how long people live without their disease coming back or getting worse. This study is currently unclear on its recruitment status and plans to enroll 151 participants.","After treatment, participants will be followed up every 6-12 months. The main goal of the study is measured up to 2 years after treatment starts.",129,"Participants will receive tretinoin by mouth and arsenic trioxide by IV daily for four weeks during induction. Some participants will also receive gemtuzumab ozogamicin by IV once during induction. After induction, participants will receive consolidation treatment for up to four courses.","Not stated in the trial record.",[31,44,59],"v2"]