Spots Global Cancer Trial Database for Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
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Trial Identification
Brief Title: Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
Official Title: A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)
Study ID: NCT04101331
Interventions
Study Description
Brief Summary: This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies. Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion). The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of overall responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood. Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients' health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center), Birmingham, Alabama, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of California Los Angeles (UCLA) Health, Los Angeles, California, United States
Emory University Clinic/Winship Cancer Institute, Atlanta, Georgia, United States
Ochsner Clinic Foundation/Precision Cancer Therapies Program, New Orleans, Louisiana, United States
University of Michigan Health | Rogel Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Center for Lymphoid Malignancies, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Washington Seattle Cancer Care Alliance, Seattle, Washington, United States
Royal Adelaide Hospital, Adelaide, , Australia
Flinders Medical Centre, Bedford Park, , Australia
Monash Health-Monash Medical Centre, Clayton, , Australia
Concord Repatriation General Hospital, Concord, , Australia
Gosford Hospital, Gosford, , Australia
Linear Clinical Research, Nedlands, , Australia
Centre Hospitalier Universitaire (CHU) de Bordeaux, Bordeaux, , France
Centre Hospitalier Universitaire de Brest, Brest, , France
CHD Vendée, La Roche Sur Yon, , France
CHU Pontchaillou, Rennes, , France
Institut Gustave Roussy, Villejuif, , France
Kliniken Essen Sued - Evangelisches Krankenhaus Essen-Werden gGmbH, Essen, , Germany
University Hospital Leipzig, Leipzig, , Germany
Universitaetsmedizin Mainz, Mainz, , Germany
Rotkreuzklinikum Muenchen, Muenchen, , Germany
Ist.Ematologia E Oncologia Medica L.E A.Seragnoli, Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia, Brescia, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, , Italy
Azienda Ospedaliera Niguarda Ca' Granda, Milano, , Italy
Azienda Unita Sanitaria Locale di Ravenna - Ospedale S. Maria delle Croci di Ravenna, Ravenna, , Italy
Chonbuk National University Hospital, Jeonju, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Szpitale Pomorskie Sp. z o.o.. Szpital Morski im. PCK, Oddzial Hematologii i Transplantologii Szpiku, Gdynia, , Poland
Pratia MCM Krakow, Kraków, , Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego, Warsaw, , Poland
Instytut Hematologii i Transfuzjologii, Klinika Hematologii, Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu. Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku, Wrocław, , Poland
Republic Hospital n.a. V.A. Baranov, Petrozavodsk, , Russian Federation
First State Saint-Petersburg Pavlov Medical University, Saint Petersburg, , Russian Federation
Saratov State Medical University, Saratov, , Russian Federation
GUZ Leningrad Regional Clinical Hospital, St. Petersburg, , Russian Federation
Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency, St. Petersburg, , Russian Federation
Regional Clinical Hospital, Tula, , Russian Federation
Duran I Reynals Hospital Catalan Institute Of Oncology, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol, Barcelona, , Spain
Institut Catala d' Oncologia Girona, Girona, , Spain
Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Institut Catala d'Oncologia Tarragona, Tarragona, , Spain
Ankara University Faculty of Medicine, Department of Internal Diseases, Hematology Division, Ankara, , Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim Arastirma Hastanesi Hematoloji Klinigi Ankara, Ankara, , Turkey
Gazi University Faculty of Medicine, Department of Internal Diseases, Ankara, , Turkey
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırm Hastanesi, Ankara, , Turkey
Istanbul Universitesi Istanbul Tip Fakultesi Ic Hastaliklari Anabilim Dali Hematoloji Bilim Dali Fatih, Istanbul, , Turkey
Ege University Medical Faculty, İzmir, , Turkey
Kocaeli University Faculty of Medicine, Department of Internal Diseases, Hematology Division, İzmit, , Turkey
Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Egitim Merkezi, Samsun, , Turkey
Tekirdag Namik Kemal Universitesi Saglik Uygulama ve Arastirma Hastanesi, Tekirdag, , Turkey
KaradenizTeknik Universitesi Tip Fakultesi Farabi Hastanesi, Trabzon, , Turkey
Contact Details
Name: Karenza Alexis, MD
Affiliation: Affimed Inc.
Role: STUDY_DIRECTOR
Name: Won Seog Kim, Dr
Affiliation: Samsung Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Steven Horwitz, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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