[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04014374":3,"trial-entities:NCT04014374":70,"trial-summary:NCT04014374":75},{"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":21,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":34,"minimum_age":35,"maximum_age":14,"healthy_volunteers":36,"eligibility_criteria":37,"std_ages":44,"locations":47,"central_contacts":57,"overall_officials":67,"references":68,"see_also_links":69},"NCT04014374","SC18-09","Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab","RECRUITING","2030-02","2024-07","2024-07-24","2019-09-10","Kyowa Kirin, Inc.","INDUSTRY",null,"This is a non-interventional cohort study evaluating non-relapse mortality and toxicities in patients with CTCL or ATLL treated with mogamulizumab pre- or post- alloHCT for patients transplanted beginning January 1, 2012 until accrual is complete.","This is an observational, retrospective and prospective study where subjects who have received mogamulizumab either within one year before or within 18 months after transplantation will be followed for data collection. Data will be collected at baseline (retrospectively), 100 days post alloHCT, 6-months, 1 year and at 2 years post alloHCT (retrospectively and prospectively).\n\nA cut-off time limit of 18 months post alloHCT exposure will allow at least 6 months of follow-up within the 2 years post-alloHCT follow-up period.",[18,19,20],"Leukemia\u002FLymphoma","Cutaneous T Cell Lymphoma","ATLL",[],"OBSERVATIONAL",[],{"count":25,"type":26},150,"ESTIMATED",[],[29],{"measure":30,"description":31,"timeFrame":32},"Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination","This study will utilize comprehensive report form (CRF) data, modified transplant essential data (TED) and supplemental data. In patients with only TED data the supplemental data will provide the required additional information for data analyses to meet the objectives of the study.","one year prior to alloHCT to within 18 months after alloHCT",[],"ALL","18 Years",false,{"inclusion":38,"exclusion":42,"raw_text":43},[39,40,41],"Patients registered to the Center for International Blood and Marrow Transplant Research (CIBMTR)","Adults ≥18 years of age with either CTCL or ATLL;","AlloHCT performed from January 2012 onward.",[],"Inclusion Criteria:\n\n* Patients registered to the Center for International Blood and Marrow Transplant Research (CIBMTR)\n* Adults ≥18 years of age with either CTCL or ATLL;\n* AlloHCT performed from January 2012 onward.\n\nExclusion Criteria:\n\n• Patients without consent for research.",[45,46],"ADULT","OLDER_ADULT",[48],{"facility":49,"status":7,"city":50,"state":51,"zip":52,"country":53,"geoPoint":54},"CIBMTR","Milwaukee","Wisconsin","53226","United States",{"lat":55,"lon":56},43.0389,-87.90647,[58,63],{"name":59,"role":60,"phone":61,"email":62},"Linda J Burns, MD","CONTACT","414-805-0714","lburns@mcw.edu",{"name":64,"role":60,"phone":65,"email":66},"Jatin Jadwani, BDS, MSc Clinical Research","+49 15114861167","jatin.jadwani@kyowakirin.com",[],[],[],{"nct_id":4,"conditions":71,"biomarkers":74},[72,73],"Adult T-Cell Leukemia\u002FLymphoma","Primary Cutaneous T-Cell Non-Hodgkin Lymphoma",[],{"nct_id":4,"found":76,"summary":77,"prompt_version":87},true,{"design":78,"status":79,"heading":80,"summary":81,"follow_up":82,"word_count":83,"commitments":84,"compensation":85,"drugs_mentioned":86},"This is an observational study, meaning researchers will collect information about your health without giving you a specific treatment. It is a retrospective and prospective study, looking at past and future data, and plans to include 150 participants.","completed","Observational Study of Mogamulizumab and Stem Cell Transplant for Leukemia\u002FLymphoma","This study is looking at the safety and side effects of allogeneic hematopoietic stem cell transplantation (alloHCT), also known as a stem cell transplant, in people who have been treated with a medicine called mogamulizumab. Mogamulizumab is used for certain types of leukemia and lymphoma, specifically Cutaneous T-Cell Lymphoma (CTCL) or Adult T-Cell Leukemia\u002FLymphoma (ATLL). Researchers want to understand if there are any toxicities (harmful effects) or complications from the transplant in patients who received mogamulizumab either before or after their transplant. You might be able to join if you are an adult (18 or older) with CTCL or ATLL, have had an alloHCT since January 2012, and are registered with the CIBMTR (Center for International Blood and Marrow Transplant Research). The study is ongoing, but the current recruitment status is unclear.","Participants will be followed for data collection up to 2 years after their stem cell transplant.",132,"Data will be collected at the start of the study (looking back at your history), and then at 100 days, 6 months, 1 year, and 2 years after your stem cell transplant.","Not stated in the trial record.",[],"v2"]