[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04022239":3,"trial-entities:NCT04022239":242,"trial-summary:NCT04022239":246},{"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":26,"interventions":29,"primary_outcomes":178,"secondary_outcomes":190,"sex":191,"minimum_age":192,"maximum_age":193,"healthy_volunteers":15,"eligibility_criteria":194,"std_ages":211,"locations":214,"central_contacts":232,"overall_officials":235,"references":238,"see_also_links":239},"NCT04022239","2018-0972","Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant","Post-Transplant Bendamustine (PT-BEN) for GVHD Prophylaxis","RECRUITING","2027-07-31","2026-07","2026-07-16","2020-03-13","M.D. Anderson Cancer Center","OTHER",false,"This phase I\u002FII trial studies the side effects and best dose of bendamustine when given with or without cyclophosphamide in preventing graft versus host disease (GVHD) in patients undergoing stem cell transplant. Drugs used in chemotherapy, such as bendamustine and cyclophosphamide, 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. Giving chemotherapy and total body irradiation before or after a stem cell transplant helps kills cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Sometimes, the transplanted cells from a donor can attack the body's normal cells called GVHD. Giving tacrolimus, mycophenolate mofetil, and filgrastim after the transplant may stop this from happening.","PRIMARY OBJECTIVE:\n\nI. Evaluate the safety of substituting the standard post-transplant cyclophosphamide (PT-CY) given on day +3 and +4 with post-transplant bendamustine (PT-BEN) in patients undergoing HLA-mismatched hematopoietic cell transplantation.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate treatment-related mortality. II. To assess acute and chronic graft-versus-host disease (GVHD). III. To assess overall survival, progression-free survival and relapse rates. IV. To evaluate the risk of acute cystitis. V. To evaluate immune reconstitution after transplantation.\n\nOUTLINE: This is a dose-escalation study of bendamustine. Patients are assigned to 1 of 2 treatment schedules.\n\nSCHEDULE I (NON-LYMPHOMA): Patients receive fludarabine intravenously (IV) over 1 hour on days -5 to -2, melphalan IV over 30 minutes on days -5 and -4, and undergo total body irradiation (TBI) on day -1 and stem cell transplantation IV over 2-6 hours on day 0. Depending on when the trial was joined, patients receive cyclophosphamide IV over 3 hours or bendamustine IV over 30-60 minutes or cyclophosphamide IV over 3 hours and bendamustine IV over 30-60 minutes on day 3. Patients also receive bendamustine IV over 30-60 minutes on day 4. Beginning day 5, patients receive tacrolimus IV followed by orally (PO) once daily (QD) or twice daily (BID) for 6 months and mycophenolate mofetil PO thrice daily (TID) until day 100. Beginning day 7, patients receive filgrastim-sndz subcutaneously (SC) QD until blood cell levels return to normal.\n\nSCHEDULE II (LYMPHOID MALIGNANCIES): Patients receive fludarabine IV over 1 hour, bendamustine IV over 30-60 minutes on days -5 to -3 and undergo TBI on day -1 and stem cell transplantation over 2-6 hours on day 0. Depending on when the trial was joined, patients receive cyclophosphamide IV over 3 hours or bendamustine IV over 30-60 minutes or cyclophosphamide IV over 3 hours and bendamustine IV over 30-60 minutes on day 3. Patients also receive bendamustine IV over 30-60 minutes on day 4. Beginning day 5, patients receive tacrolimus IV followed by PO QD or BID for 6 months and mycophenolate mofetil PO TID until day 100. Beginning day 7, patients receive filgrastim-sndz SC QD until blood cell levels return to normal. CD20+ patients receive rituximab IV over 4-6 hours on days -13, -6, 1, and 8.\n\nAfter completion of study treatment, patients are followed weekly for 3 months, every 3 months in year 1, and every 6 months in year 2.",[19],"Hematopoietic and Lymphoid System Neoplasm",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},25,"ESTIMATED",[30,44,51,89,97,102,119,126,157,167],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":37},"PROCEDURE","Allogeneic Hematopoietic Stem Cell Transplantation","Undergo stem cell transplantation",[35,36],"Schedule I (non-lymphoma)","Schedule II (lymphoid malignancies)",[38,39,40,41,42,43],"Allogeneic","Allogeneic Hematopoietic Cell Transplantation","Allogeneic Stem Cell Transplantation","HSC","HSCT","Stem Cell Transplantation, Allogeneic",{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","Bendamustine","Given IV",[35,36],[50],"SDX-105",{"type":45,"name":52,"description":47,"armGroupLabels":53,"otherNames":54},"Cyclophosphamide",[35,36],[55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"(-)-Cyclophosphamide","2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate","Carloxan","Ciclofosfamida","Ciclofosfamide","Cicloxal","Clafen","Claphene","CP monohydrate","CTX","CYCLO-cell","Cycloblastin","Cycloblastine","Cyclophospham","Cyclophosphamid monohydrate","Cyclophosphamide Monohydrate","Cyclophosphamidum","Cyclophosphan","Cyclophosphane","Cyclophosphanum","Cyclostin","Cyclostine","Cytophosphan","Cytophosphane","Cytoxan","Fosfaseron","Genoxal","Genuxal","Ledoxina","Mitoxan","Neosar","Revimmune","Syklofosfamid","WR- 138719",{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":94},"BIOLOGICAL","Filgrastim-sndz","Given SC",[35,36],[95,96],"Filgrastim Biosimilar Filgrastim-sndz","Zarxio",{"type":45,"name":98,"description":47,"armGroupLabels":99,"otherNames":100},"Fludarabine",[35,36],[101],"Fluradosa",{"type":45,"name":103,"description":47,"armGroupLabels":104,"otherNames":105},"Melphalan",[35],[106,107,108,109,110,111,112,113,114,115,116,117,118],"Alanine Nitrogen Mustard","CB-3025","L-PAM","L-Phenylalanine Mustard","L-Sarcolysin","L-Sarcolysin Phenylalanine mustard","L-Sarcolysine","Melphalanum","Phenylalanine Mustard","Phenylalanine Nitrogen Mustard","Sarcoclorin","Sarkolysin","WR-19813",{"type":45,"name":120,"description":121,"armGroupLabels":122,"otherNames":123},"Mycophenolate Mofetil","Given PO",[35,36],[124,125],"CellCept","MMF",{"type":90,"name":127,"description":47,"armGroupLabels":128,"otherNames":129},"Rituximab",[36],[130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156],"ABP 798","BI 695500","C2B8 Monoclonal Antibody","Chimeric Anti-CD20 Antibody","CT-P10","IDEC-102","IDEC-C2B8","IDEC-C2B8 Monoclonal Antibody","MabThera","Monoclonal Antibody IDEC-C2B8","PF-05280586","Rituxan","Rituximab ABBS","Rituximab Biosimilar ABP 798","Rituximab Biosimilar BI 695500","Rituximab Biosimilar CT-P10","Rituximab Biosimilar GB241","Rituximab Biosimilar IBI301","Rituximab Biosimilar JHL1101","Rituximab Biosimilar PF-05280586","Rituximab Biosimilar RTXM83","Rituximab Biosimilar SAIT101","Rituximab Biosimilar SIBP-02","rituximab biosimilar TQB2303","rituximab-abbs","RTXM83","Truxima",{"type":45,"name":158,"description":159,"armGroupLabels":160,"otherNames":161},"Tacrolimus","Given IV and PO",[35,36],[162,163,164,165,166],"FK 506","Fujimycin","Hecoria","Prograf","Protopic",{"type":168,"name":169,"description":170,"armGroupLabels":171,"otherNames":172},"RADIATION","Total-Body Irradiation","Undergo TBI",[35,36],[173,174,175,176,177],"SCT_TBI","TBI","Total Body Irradiation","Whole Body Irradiation","Whole-Body Irradiation",[179,183,186],{"measure":180,"description":181,"timeFrame":182},"Maximum tolerated dose level (MTDL) (Phase I)","Will employ the time-to-event Bayesian optimal interval design to find the MTDL. After the trial is completed, the MTDL will be selected based on isotonic regression as specified in Yuan et al. Specifically, MTDL will be selected as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there are ties, the higher dose level when the isotonic estimate is lower than the target toxicity rate will be selected and the lower dose level when the isotonic estimate is greater than or equal to the target toxicity rate will be selected.","Up to 30 days",{"measure":184,"timeFrame":185},"Dose-limiting toxicity (Phase I)","Up to 100 days",{"measure":187,"description":188,"timeFrame":189},"Incidence of adverse events (Phase II)","The trial is continuously monitored for toxicity per the statistical design.","Up to 2 years",[],"ALL","18 Years","70 Years",{"inclusion":195,"exclusion":201,"raw_text":210},[196,197,198,199,200],"Patient with hematologic malignancies.","Donor: Matched sibling, matched unrelated, mismatched or haploidentical","Zubrod performance 0 to 2 or Karnofsky of at least 60.","Adequate organ function at time of study entry:","Female patients of childbearing potential must agree to use an effective method of birth control while on study and for 6 months after the last dose of bendamustine. Male patients with female partners of childbearing potential must agree to use an effective method of birth control while on study and for 3 months after the last dose of bendamustine.",[202,203,204,205,206,207,208,209],"Pregnant or nursing women.","Known to be HIV positive","Active and uncontrolled disease\u002Finfection","Unable or unwilling to sign consent","Current active hepatic or biliary disease (with exception of Gilbert's syndrome)","Active hepatitis B or C.","Toxicities (grade \\> 1) unresolved from prior treatment (including chemotherapy, targeted therapy, immunotherapy, experimental agents radiation, or surgery.","Patients with standard risk acute leukemia in first complete remission and patients with chronic myeloid leukemia in first chronic will be excluded during escalated phase.","Inclusion Criteria:\n\n* Patient with hematologic malignancies.\n* Donor: Matched sibling, matched unrelated, mismatched or haploidentical\n* Zubrod performance 0 to 2 or Karnofsky of at least 60.\n* Adequate organ function at time of study entry:\n\n  1. Creatinine less than or equal to 1.6 mg\u002FdL and creatinine clearance \\>\u002F= 30 ml\u002Fmin. Creatinine clearance will be calculated using the Cockcroft-Gault equation\n  2. Total bilirubin less than \\\u003C 1.5 x UNL\n  3. SGPT \\\u003C 2.5 x ULN\n  4. Ejection fraction \\>\u002F= 40%\n  5. FEV1, FVC and DLCO \\>\u002F= 40%\n* Female patients of childbearing potential must agree to use an effective method of birth control while on study and for 6 months after the last dose of bendamustine. Male patients with female partners of childbearing potential must agree to use an effective method of birth control while on study and for 3 months after the last dose of bendamustine.\n\nExclusion Criteria:\n\n* Pregnant or nursing women.\n* Known to be HIV positive\n* Active and uncontrolled disease\u002Finfection\n* Unable or unwilling to sign consent\n* Current active hepatic or biliary disease (with exception of Gilbert's syndrome)\n* Active hepatitis B or C.\n* Toxicities (grade \\> 1) unresolved from prior treatment (including chemotherapy, targeted therapy, immunotherapy, experimental agents radiation, or surgery.\n* Patients with standard risk acute leukemia in first complete remission and patients with chronic myeloid leukemia in first chronic will be excluded during escalated phase.",[212,213],"ADULT","OLDER_ADULT",[215],{"facility":216,"status":8,"city":217,"state":218,"zip":219,"country":220,"contacts":221,"geoPoint":229},"M D Anderson Cancer Center","Houston","Texas","77030","United States",[222,227],{"name":223,"role":224,"phone":225,"email":226},"Issa F. Khouri","CONTACT","713-745-0049","ikhouri@mdanderson.org",{"name":223,"role":228},"PRINCIPAL_INVESTIGATOR",{"lat":230,"lon":231},29.76328,-95.36327,[233],{"name":234,"role":224,"phone":225,"email":226},"Issa F. Khouri, M D",[236],{"name":237,"affiliation":13,"role":228},"Issa F Khouri",[],[240],{"label":216,"url":241},"http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":243,"biomarkers":245},[244],"Hematologic Neoplasm",[],{"nct_id":4,"found":247,"summary":248,"prompt_version":258},true,{"design":249,"status":250,"heading":251,"summary":252,"follow_up":253,"word_count":254,"commitments":255,"compensation":256,"drugs_mentioned":257},"This is a dose-escalation study with 25 planned participants. Patients will be assigned to one of two treatment schedules.","completed","Bendamustine with or without Cyclophosphamide for GVHD Prevention in Stem Cell Transplant","This study is looking at the safety and best dose of bendamustine, with or without cyclophosphamide, to prevent graft-versus-host disease (GVHD) in patients having a stem cell transplant. GVHD happens when the new donor cells attack your body's healthy cells. The study aims to see if bendamustine can be used instead of or with cyclophosphamide after your transplant. You might be eligible if you are 18-70 years old, have a blood cancer, and meet certain health requirements. Researchers will measure side effects for up to two years to understand how well the treatments are tolerated and how they affect your recovery and survival.","Researchers will monitor you for adverse events for up to two years after treatment.",103,"You will receive several intravenous (IV) medications, including fludarabine, melphalan, and bendamustine or cyclophosphamide, around the time of your stem cell transplant. You will also undergo total body irradiation and the stem cell transplant procedure itself.","Not stated in the trial record.",[46,52],"v2"]