Universität zu Köln

Sasse, Stephanie, Brockelmann, Paul Jan, Momotow, Jesko, Plutschow, Annette, Huttmann, Andreas, Basara, Nadezda, Koenecke, Christian, Martin, Sonja, Bentz, Martin, Grosse-Thie, Christina, Thorspecken, Sven, de Wit, Maike, Kobe, Carsten, Dietlein, Markus, v Tresckow, Bastian, Fuchs, Michael, Borchmann, Peter and Engert, Andreas (2022). AFM13 in patients with relapsed or refractory classical Hodgkin lymphoma: final results of an open-label, randomized, multicenter phase II trial. Leuk. Lymphoma, 63 (8). S. 1871 - 1879. ABINGDON: TAYLOR & FRANCIS LTD. ISSN 1029-2403

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Abstract

In patients with relapse of classical Hodgkin lymphoma (cHL) after autologous stem cell transplant, brentuximab vedotin and anti-PD1 treatment, the outcome is poor. To assess the efficacy of the bispecific anti-CD30/CD16A, NK-cell engaging antibody AFM13 and to select the optimal treatment schedule (arm A-C), we initiated a randomized two-stage phase II trial (NCT02321592). Due to slow recruitment, the trial was terminated after treatment of 25 patients. Treatment with AFM13 was well tolerated: only two treatment-associated serious adverse events (SAEs) were reported; all SAEs resolved completely. With an objective response rate (ORR) of 16.7% (1/5 in arm A, 1/11 in arm B, and 2/8 in arm C) and a 12-month progression-free survival (PFS) of 12.6% (95% CI 3.2-28.9), treatment efficacy of AFM13 monotherapy in all evaluable patients was modest. The continuous application schedule (arm C) might be more effective, but the visit schedule should be better aligned with patients' daily life.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Sasse, Stephanie UNSPECIFIED UNSPECIFIED UNSPECIFIED Brockelmann, Paul Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED Momotow, Jesko UNSPECIFIED UNSPECIFIED UNSPECIFIED Plutschow, Annette UNSPECIFIED UNSPECIFIED UNSPECIFIED Huttmann, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Basara, Nadezda UNSPECIFIED UNSPECIFIED UNSPECIFIED Koenecke, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Martin, Sonja UNSPECIFIED UNSPECIFIED UNSPECIFIED Bentz, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Grosse-Thie, Christina UNSPECIFIED UNSPECIFIED UNSPECIFIED Thorspecken, Sven UNSPECIFIED UNSPECIFIED UNSPECIFIED de Wit, Maike UNSPECIFIED UNSPECIFIED UNSPECIFIED Kobe, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Dietlein, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED v Tresckow, Bastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Fuchs, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Borchmann, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Engert, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-691208
DOI:	10.1080/10428194.2022.2095623
Journal or Publication Title:	Leuk. Lymphoma
Volume:	63
Number:	8
Page Range:	S. 1871 - 1879
Date:	2022
Publisher:	TAYLOR & FRANCIS LTD
Place of Publication:	ABINGDON
ISSN:	1029-2403
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CELL TRANSPLANTATION; RECOVERY; SURVIVAL Multiple languages Oncology; Hematology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/69120