Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Megadott ok: Study discontinued as DSMB determined it was futile. No safety concerns were noted.
A legfontosabb adatok
- Hol
- Atlanta, Aurora, Baltimore, Birmingham, Boston, Buffalo, Charlotte, Charlottesville, Columbus, Dallas, Duarte, Gainesville, Hackensack, Indianapolis, Kansas City, Los Angeles, Maywood, Milwaukee, Minneapolis, New Haven, New York, Palo Alto, Philadelphia, Portland, Richmond, Salt Lake City, San Francisco, Scottsdale, Seattle, St Louis, Stony Brook, Tampa és Washington D.C. (Egyesült Államok)Mind a 35 helyszín megnézése
- Fázis
- 2/3. fázis
Helyszínek itt: Egyesült Államok
- Northside HospitalAtlanta, Egyesült ÁllamokNo longer taking part
- University of Colorado HospitalAurora, Egyesült ÁllamokNo longer taking part
- University of MarylandBaltimore, Egyesült ÁllamokNo longer taking part
- University of Alabama at Birmingham, Children's of AlabamaBirmingham, Egyesült ÁllamokNo longer taking part
- Dana-Farber Cancer InstituteBoston, Egyesült ÁllamokNo longer taking part
- Roswell Park Cancer InstituteBuffalo, Egyesült ÁllamokNo longer taking part
- Carolinas Medical Center/LevineCharlotte, Egyesült ÁllamokNo longer taking part
- University of VirginiaCharlottesville, Egyesült ÁllamokNo longer taking part
- Nationwide Children's HospitalColumbus, Egyesült ÁllamokNo longer taking part
- Children's Medical Center DallasDallas, Egyesült ÁllamokNo longer taking part
- City of HopeDuarte, Egyesült ÁllamokNo longer taking part
- University of Florida (UF) - GainesvilleGainesville, Egyesült ÁllamokNo longer taking part
- Hackensack University Medical CenterHackensack, Egyesült ÁllamokNo longer taking part
- Indiana University Hospital Simon Comprehensive Cancer CenterIndianapolis, Egyesült ÁllamokNo longer taking part
- Children's Mercy HospitalKansas City, Egyesült ÁllamokNo longer taking part
- University of Kansas HospitalKansas City, Egyesült ÁllamokNo longer taking part
- University of California Los Angeles (UCLA).Los Angeles, Egyesült ÁllamokNo longer taking part
- Loyola University Medical CenterMaywood, Egyesült ÁllamokNo longer taking part
- Froedtert Hospital and the Medical College of WisconsinMilwaukee, Egyesült ÁllamokNo longer taking part
- University of MinnesotaMinneapolis, Egyesült ÁllamokNo longer taking part
- Yale University School of Medicine - Yale Cancer CenterNew Haven, Egyesült ÁllamokNo longer taking part
- Columbia UniversityNew York, Egyesült ÁllamokNo longer taking part
- Weill Cornell Medical CollegeNew York, Egyesült ÁllamokNo longer taking part
- Stanford UniversityPalo Alto, Egyesült ÁllamokNo longer taking part
- University of PennsylvaniaPhiladelphia, Egyesült ÁllamokNo longer taking part
- Oregon Health Science UniversityPortland, Egyesült ÁllamokNo longer taking part
- Virginia Commonwealth UniversityRichmond, Egyesült ÁllamokNo longer taking part
- University of Utah/Primary Childrens HospitalSalt Lake City, Egyesült ÁllamokNo longer taking part
- University of California San Francisco-Benioff Children's HospitalSan Francisco, Egyesült ÁllamokNo longer taking part
- Honor Health Research InstituteScottsdale, Egyesült ÁllamokNo longer taking part
- Fred Hutchinson Cancer Research CenterSeattle, Egyesült ÁllamokNo longer taking part
- Washington University School of MedicineSt Louis, Egyesült ÁllamokNo longer taking part
- Stony Brook University Hospital Cancer CenterStony Brook, Egyesült ÁllamokNo longer taking part
- Moffitt Cancer CenterTampa, Egyesült ÁllamokNo longer taking part
- Childrens National Health SystemWashington D.C., Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- AlloVir
- Azonosító
- NCT05305040
- A regiszteradat frissítve
- 2024. május 16.
- Eredeti leírás
This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.A teljes eredeti leírásKevesebb
Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (ALVR105,Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.
Bevonási feltételek: Any age at the day of screening visit; No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV; Within 25 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment at time of dosing; Meet one or more of the following criteria at the time of randomization:; Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR; Haploidentical donor; Matched or Mismatched unrelated donor; Use of umbilical cord blood as stem cell source; Ex vivo graft manipulation resulting in T cell depletion; Received anti-thymocyte globulin or alemtuzumab (Campath-1H).
Kizáró feltételek: History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization; Known history or current (suspected) diagnosis of Grade ≥3 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies; Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >1.0 mg/kg/day) within 24 hours prior to dosing; Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections; Relapse of primary malignancy other than minimal residual disease; Note: Other protocol defined Inclusion/Exclusion criteria may apply; Evidence of active Grade >2 acute GVHD.