Immune Checkpoint Inhibitors and Radiotherapy in Relapsed/Refractory Hodgkin Lymphoma
NCT ID: NCT04419441
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
12 participants
OBSERVATIONAL
2020-06-24
2020-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma
NCT03179917
Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
NCT04052997
Assessment of Safety and Efficacy of IM19 for Relapsed or Refractory NHL Patients
NCT03528421
Prognosis of Patients With Relapsed/Refractory Hodgkin Lymphoma Treated With IGEV Induction Therapy Before HDCT With AHSCT
NCT01478191
Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
NCT01896999
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Strategies to improve CR rates should therefore be implemented, including combination treatments. In solid tumors, the combination of ICIs and radiotherapy led to higher response rates without mjor toxicity concerns. Radiotherapy is an effective therapeutic option already used in Hodgkin lymphoma patients, also in the setting of relapsed/refractory disease. In his observational study we aim to evaluate the efficacy and safety of ICIs and radiotherapy administered in combination in patients with relapsed/refractory Hodgkin lymphoma.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
treated patients
patients with relapsed/refractory Hodgkin lymphoma who received a treatment with the combination of radiotherapy and an immune checkpoint inhibitor
Immune checkpoint inhibitor
concomitant administration of radiotherapy and immune checkpoint inhibitor
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immune checkpoint inhibitor
concomitant administration of radiotherapy and immune checkpoint inhibitor
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* diagnosis of classical Hodgkin lymphoma, treated with one immune checkpoint inhibitor (ICI) (nivolumab or pembrolizumab), as per label indication
* having received a concomitant radiotherapy, as per clinical need (persistence of localized disease, bulky disease, other reasons). "Concomitant" radiotherapy means a treatment received during the administration of ICI, or during the 8 weeks that precede or follow the start or the end of the treatment with ICI
Exclusion Criteria
* Having received any other anti-lymphoma treatments during the same period of time
* Patients who have not been evaluated by CT-PET or CT at the end of the combination therapy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ospedale Maggiore Di Trieste
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francesco Zaja
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francesco Zaja, Professor
Role: PRINCIPAL_INVESTIGATOR
SC Ematologia Ospedale Maggiore Trieste
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SC Ematologia Ospedale Maggiore
Trieste, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.
Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.
Cheson BD, Ansell S, Schwartz L, Gordon LI, Advani R, Jacene HA, Hoos A, Barrington SF, Armand P. Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy. Blood. 2016 Nov 24;128(21):2489-2496. doi: 10.1182/blood-2016-05-718528. Epub 2016 Aug 29.
Armand P, Engert A, Younes A, Fanale M, Santoro A, Zinzani PL, Timmerman JM, Collins GP, Ramchandren R, Cohen JB, De Boer JP, Kuruvilla J, Savage KJ, Trneny M, Shipp MA, Kato K, Sumbul A, Farsaci B, Ansell SM. Nivolumab for Relapsed/Refractory Classic Hodgkin Lymphoma After Failure of Autologous Hematopoietic Cell Transplantation: Extended Follow-Up of the Multicohort Single-Arm Phase II CheckMate 205 Trial. J Clin Oncol. 2018 May 10;36(14):1428-1439. doi: 10.1200/JCO.2017.76.0793. Epub 2018 Mar 27.
Chen R, Zinzani PL, Lee HJ, Armand P, Johnson NA, Brice P, Radford J, Ribrag V, Molin D, Vassilakopoulos TP, Tomita A, von Tresckow B, Shipp MA, Lin J, Kim E, Nahar A, Balakumaran A, Moskowitz CH. Pembrolizumab in relapsed or refractory Hodgkin lymphoma: 2-year follow-up of KEYNOTE-087. Blood. 2019 Oct 3;134(14):1144-1153. doi: 10.1182/blood.2019000324. Epub 2019 Aug 13.
Constine LS, Yahalom J, Ng AK, Hodgson DC, Wirth A, Milgrom SA, Mikhaeel NG, Eich HT, Illidge T, Ricardi U, Dieckmann K, Moskowitz CH, Advani R, Mauch PM, Specht L, Hoppe RT. The Role of Radiation Therapy in Patients With Relapsed or Refractory Hodgkin Lymphoma: Guidelines From the International Lymphoma Radiation Oncology Group. Int J Radiat Oncol Biol Phys. 2018 Apr 1;100(5):1100-1118. doi: 10.1016/j.ijrobp.2018.01.011. Epub 2018 Jan 9.
Chen L, Douglass J, Kleinberg L, Ye X, Marciscano AE, Forde PM, Brahmer J, Lipson E, Sharfman W, Hammers H, Naidoo J, Bettegowda C, Lim M, Redmond KJ. Concurrent Immune Checkpoint Inhibitors and Stereotactic Radiosurgery for Brain Metastases in Non-Small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma. Int J Radiat Oncol Biol Phys. 2018 Mar 15;100(4):916-925. doi: 10.1016/j.ijrobp.2017.11.041. Epub 2017 Dec 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ICI-RT-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.