Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology 
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  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Trial completion date, Trial primary completion date:  Study of E7777 Prior to Kymriah for R/R DLBCL (clinicaltrials.gov) -  Jan 9, 2025   
    P1/2,  N=30, Recruiting, 
    These results indicate that the presence of ADAs decreased E7777 exposure over time but did not adversely impact efficacy and safety in patients with CTCL. Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    MECHANISMS OF T CELL TOLERANCE AFTER PT-CY HAPLOTRANSPLANTATION (North Hall / Virtual Hall 6) -  Jan 30, 2022 - Abstract #EBMT2022EBMT_924;    
    We found Treg, Tr1 activity, or T-cell exhaustion to be insignificant as their removal or blocking antibodies did not lead to ‘flare’ in T-cell reactivity against patient DC. T-cell clonal deletion appears to be the dominant mechanism explaining the in vitro hyporeactive proliferation, cytokine secretion, and alloreactive TCR clonotype attrition.
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Trial completion:  study-302: A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov) -  Jan 18, 2022   
    P3,  N=115, Completed, 
    T-cell clonal deletion appears to be the dominant mechanism explaining the in vitro hyporeactive proliferation, cytokine secretion, and alloreactive TCR clonotype attrition. Active, not recruiting --> Completed
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, I/ONTAK (denileukin diftitox purified) / Citius, Eisai
    Mechanisms of T Cell Tolerance after Ptcy Haplotransplantation (Salt Palace Convention Center Ballroom J) -  Dec 3, 2021 - Abstract #TCTASTCTCIBMTR2022TCT_ASTCT_CIBMTR_372;    
    All received Flu+TBI (+/- Cy) pre-conditioning and haplo-HSCT with post-transplant Cytoxan (PTCy) and FK506 as GvHD prophylaxis...To test the involvement of Tregs, we depleted them from purified T cells with Denileukin Diftitox (IL2R immunotoxin, Seragen Inc™) pre-incubation...T-cell exhaustion was tested by blocking the PD1 pathway with anti-PD1 MoAb (OPDIVO, Bristol Myers Squibb™)...T-cell clonal deletion appears to be the dominant mechanism explaining the in vitro hyporeactive proliferation, cytokine secretion, and alloreactive TCR clonotype attrition. Anergy may play a minor supportive role.
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Trial completion date, Trial primary completion date:  study-302: A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov) -  Oct 15, 2021   
    P3,  N=115, Active, not recruiting, 
    Anergy may play a minor supportive role. Trial completion date: Sep 2021 --> Feb 2022 | Trial primary completion date: Sep 2021 --> Feb 2022
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Enrollment closed:  study-302: A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov) -  Aug 16, 2021   
    P3,  N=115, Active, not recruiting, 
    Trial completion date: Sep 2021 --> Feb 2022 | Trial primary completion date: Sep 2021 --> Feb 2022 Recruiting --> Active, not recruiting
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Enrollment open:  Study of E7777 Prior to Kymriah for R/R DLBCL (clinicaltrials.gov) -  Jul 14, 2021   
    P1/2,  N=30, Recruiting, 
    Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    New P1/2 trial:  Study of E7777 Prior to Kymriah for R/R DLBCL (clinicaltrials.gov) -  Apr 22, 2021   
    P1/2,  N=30, Not yet recruiting, 
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Trial completion date, Trial primary completion date:  study-302: A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov) -  Oct 9, 2020   
    P3,  N=115, Recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Mar 2021 --> Aug 2021 | Trial primary completion date: Mar 2021 --> Aug 2021
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Trial completion date, Trial primary completion date:  study-302: A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov) -  May 14, 2020   
    P3,  N=115, Recruiting, 
    Trial completion date: Mar 2021 --> Aug 2021 | Trial primary completion date: Mar 2021 --> Aug 2021 Trial completion date: Apr 2020 --> Mar 2021 | Trial primary completion date: Mar 2020 --> Mar 2021
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Enrollment open:  study-302: A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov) -  Feb 5, 2020   
    P3,  N=115, Recruiting, 
    Trial completion date: Apr 2020 --> Mar 2021 | Trial primary completion date: Mar 2020 --> Mar 2021 Active, not recruiting --> Recruiting
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Trial completion date, Trial primary completion date:  study-302: A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov) -  Oct 16, 2019   
    P3,  N=70, Active, not recruiting, 
    Active, not recruiting --> Completed Trial completion date: Dec 2019 --> Mar 2020 | Trial primary completion date: Dec 2019 --> Mar 2020
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Enrollment closed:  study-302: A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov) -  Sep 30, 2019   
    P3,  N=70, Active, not recruiting, 
    Trial completion date: Dec 2019 --> Mar 2020 | Trial primary completion date: Dec 2019 --> Mar 2020 Recruiting --> Active, not recruiting
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Trial completion date, Trial primary completion date:  study-302: A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov) -  Apr 22, 2019   
    P3,  N=70, Recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Jun 2019 --> Dec 2019 | Trial primary completion date: Jun 2019 --> Dec 2019
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Enrollment change, Trial primary completion date:  study-302: A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov) -  Aug 22, 2018   
    P3,  N=56, Recruiting, 
    Trial completion date: Dec 2018 --> Jun 2019 | Trial primary completion date: Dec 2018 --> Jun 2019 N=90 --> 56 | Trial primary completion date: Mar 2019 --> Jun 2019
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology
    Enrollment open, Enrollment change, Trial initiation date, Trial primary completion date:  study-302: A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma (clinicaltrials.gov) -  Aug 12, 2016   
    P3,  N=90, Recruiting, 
    Trial primary completion date: Jun 2019 --> Mar 2019 N=21 --> 90 | Initiation date: May 2013 --> May 2016 | Trial primary completion date: Sep 2016 --> Jun 2019 | Active, not recruiting --> Recruiting
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Citius, Eisai
    Enrollment change, Trial primary completion date:  E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma (clinicaltrials.gov) -  Jun 6, 2015   
    P1,  N=13, Active, not recruiting, 
    N=90 --> 21 N=24 --> 13 | Trial primary completion date: Mar 2015 --> Aug 2015
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Citius, Eisai
    Enrollment closed:  E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma (clinicaltrials.gov) -  Mar 12, 2015   
    P1,  N=24, Active, not recruiting, 
    N=24 --> 13 | Trial primary completion date: Mar 2015 --> Aug 2015 Recruiting --> Active, not recruiting
  • ||||||||||  Lymphir (denileukin diftitox-cxdl) / Citius, Eisai
    Trial primary completion date:  E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma (clinicaltrials.gov) -  Dec 17, 2014   
    P1,  N=24, Recruiting, 
    Recruiting --> Active, not recruiting Trial primary completion date: Sep 2014 --> Mar 2015