Immune Checkpoint Inhibitors and Radiotherapy in Relapsed/Refractory Hodgkin Lymphoma

NCT04419441 | Unknown FDA Drug

• 1 other identifier: ICI-RT-01
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational retrospective study to investigate the efficacy and safety of the treatment with an immune checkpoint inhibitor (nivolumab or pembrolizumab) in combination with radiotherapy in patients with relapsed/refractory classical Hodgkin lymphoma.

Conditions

Hodgkin Lymphoma; Immune Checkpoint Inhibitor; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Complete remission (CR) rate measured according to Lugano and Lyric criteria by CT-PET (positron emission tomography / computer tomography) or CT (computer tomography) scan

  up to 2 months after the end of ICI or 3 months after the end of RT

Secondary Outcomes (3)

• overall response rate (ORR) measured according to Lugano and Lyric criteria by CT-PET or CT scan

  up to 2 months after the end of ICI or 3 months after the end of RT

• progression-free survival (PFS) measured according to Cheson 2007 response criteria

  from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 5 years

• safety profile assessed by monitoring adverse events (AEs) and serious adverse events (SAEs) according to CTCAE v. 4.0

  through study completion, for an average of 1 year

Study Arms (1)

treated patients

patients with relapsed/refractory Hodgkin lymphoma who received a treatment with the combination of radiotherapy and an immune checkpoint inhibitor

Drug: Immune checkpoint inhibitor

Interventions

Immune checkpoint inhibitor DRUG

concomitant administration of radiotherapy and immune checkpoint inhibitor

Also known as: radiotherapy

treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population includes adult patients with relapsed/refractory Hodgkin lymphoma treated in referral centers for haematology

You may qualify if:

• age ≥18 years
• 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

You may not qualify if:

• Having received a treatment with an ICI and radiotherapy not "concomitant", according to the abovementioned definition
• 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

Sponsors & Collaborators

• Ospedale Maggiore Di Trieste: lead

Study Sites (1)

SC Ematologia Ospedale Maggiore

Trieste, 34100, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 17242396 BACKGROUND

• 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.

  PMID: 25113753 BACKGROUND

• 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.

  PMID: 27574190 BACKGROUND

• 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.

  PMID: 29584546 BACKGROUND

• 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.

  PMID: 31409671 BACKGROUND

• 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.

  PMID: 29722655 BACKGROUND

• 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.

  PMID: 29485071 BACKGROUND

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Immune Checkpoint Inhibitors; Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Therapeutics

Study Officials

• Francesco Zaja, Professor

  SC Ematologia Ospedale Maggiore Trieste

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Zaja, Professor

CONTACT

+390403992888; francesco.zaja@asugi.sanita.fvg.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: June 24, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

IT (1)