[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03850366":3,"trial-entities:NCT03850366":90,"trial-summary:NCT03850366":94},{"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":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":65,"locations":68,"central_contacts":83,"overall_officials":87,"references":88,"see_also_links":89},"NCT03850366","10313","HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib","HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib Following Fludarbine\u002FMelphalan\u002FTotal Body Irradiation Conditioning Regimen","RECRUITING","2028-01-01","2026-02","2026-02-24","2016-03-08","Henry Ford Health System","OTHER",null,"Now haplo stem cell transplant using bone marrow or peripheral blood is becoming more feasible with better regimens to prevent graft versus host disease (GVHD) like post transplant cyclophosphamide , tacrolimus, mycophenolate . Recently Bortezomib has also been shown to inhibit dendritic cells maturation and function and possesses a number of other favorable immunomodulatory effect that can prevent GVHD and help enhance immune reconstitution. this study is to assess the engraftment rate in patients with hematologic malignancies who need allogeneic stem cell transplant but do not have a suitable matched related or unrelated stem cell donor and will get T-cell replete HLA-Haploidentical allogeneic peripheral stem cell transplantation using post transplant Cyclophosphamide and bortezomib",[18],"Hematological Malignancy",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE2",{"count":25,"type":26},15,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Bortezomib","GVHD prophylaxis",[30],[34],"cyclophosphamide",[36],{"measure":37,"description":38,"timeFrame":39},"engraftment rate","rate of neutrophil and platelet engraftment post stem cell transplant","within 30 days post transplant",[],"ALL","18 Years","65 Years",false,{"inclusion":46,"exclusion":56,"raw_text":64},[47,48,49,50,51,52,53,54,55],"18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (\\\u003C\u002F= 7\u002F8 allele match at the A, B, C, DR loci with a minimum match of 5\u002F10 is required) is identified","Candidate for stem cell transplant in a malignant hematological condition","Karnofsky Performance Scale 0-1","Available donor able to undergo a Peripheral blood stem cells collection","Bilirubin \\\u003C\u002F= 1.5 mg\u002Fdl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\\u003C\u002F= 200 IU\u002Fml for adults.","Serum creatinine clearance \\>\u002F=60 ml\u002Fmin (calculated with Cockroft-Gault formula)","Diffusing capacity for carbon monoxide (DLCO) \\>\u002F= 45% predicted corrected for hemoglobin.","Left ventricle ejection fraction \\> 40%.","Patient or patient's legal representative, parent(s) or guardian should provide written informed consent.",[57,58,59,60,61,62,63],"Adult who has a suitable related or unrelated donor or cord units available for transplant. Suitable donors include 8\u002F8 (HLA-A,B,C and DR, with all loci high-resolution typing) or 7\u002F8 related or unrelated donor available within 42 days of search initiation","HIV positive; active hepatitis B or C","Patients with active uncontrolled infections.","Liver cirrhosis","Uncontrolled central nervous system involvement by tumor cells","Positive Beta Human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.","Inability to comply with medical therapy or follow-up","Inclusion Criteria:\n\n* 18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (\\\u003C\u002F= 7\u002F8 allele match at the A, B, C, DR loci with a minimum match of 5\u002F10 is required) is identified\n* Candidate for stem cell transplant in a malignant hematological condition\n* Karnofsky Performance Scale 0-1\n* Available donor able to undergo a Peripheral blood stem cells collection\n* Bilirubin \\\u003C\u002F= 1.5 mg\u002Fdl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\\u003C\u002F= 200 IU\u002Fml for adults.\n* Serum creatinine clearance \\>\u002F=60 ml\u002Fmin (calculated with Cockroft-Gault formula)\n* Diffusing capacity for carbon monoxide (DLCO) \\>\u002F= 45% predicted corrected for hemoglobin.\n* Left ventricle ejection fraction \\> 40%.\n* Patient or patient's legal representative, parent(s) or guardian should provide written informed consent.\n\nExclusion Criteria:\n\n* Adult who has a suitable related or unrelated donor or cord units available for transplant. Suitable donors include 8\u002F8 (HLA-A,B,C and DR, with all loci high-resolution typing) or 7\u002F8 related or unrelated donor available within 42 days of search initiation\n* HIV positive; active hepatitis B or C\n* Patients with active uncontrolled infections.\n* Liver cirrhosis\n* Uncontrolled central nervous system involvement by tumor cells\n* Positive Beta Human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.\n* Inability to comply with medical therapy or follow-up",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":80},"Henry Ford hospital","Detroit","Michigan","48202","United States",[76],{"name":77,"role":78,"phone":79},"shatha farhan","CONTACT","313-916-5002",{"lat":81,"lon":82},42.33143,-83.04575,[84],{"name":77,"role":78,"phone":85,"email":86},"313 713 3910","sfarhan1@hfhs.org",[],[],[],{"nct_id":4,"conditions":91,"biomarkers":93},[92],"Hematologic Neoplasm",[],{"nct_id":4,"found":95,"summary":96,"prompt_version":106},true,{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 15 participants.","completed","Haploidentical Stem Cell Transplant with Bortezomib for Blood Cancers","This study is looking at a type of stem cell transplant called a haploidentical transplant for people with blood cancers (hematological malignancies) who don't have a fully matched donor. It's testing if adding the drug Bortezomib to the usual treatment (post-transplant cyclophosphamide) can help prevent graft-versus-host disease (GVHD), a common complication where the donor cells attack your body. The study aims to see how well the new stem cells engraft (start growing) in your body within 30 days after the transplant. You might be able to join if you are 18-65 years old, have a blood cancer, and have a partially matched family donor. The study is currently unclear on its recruitment status and plans to enroll 15 participants.","The primary goal is measured within 30 days post-transplant, focusing on engraftment rate.",119,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]