Universität zu Köln

Gillessen, Sarah, Pluetschow, Annette, Vucinic, Vladan ORCID: 0000-0002-8398-285X, Ostermann, Helmut, Kobe, Carsten, Broeckelmann, Paul J., Boell, Boris, Eichenauer, Dennis A., Heger, Jan-Michel ORCID: 0000-0001-9463-8504, Borchmann, Sven, Fuchs, Michael, Borchmann, Peter, Engert, Andreas and von Tresckow, Bastian (2022). JAK inhibition with ruxolitinib in relapsed or refractory classical Hodgkin lymphoma: Final results of a phase II, open label, multicentre clinical trial (JeRiCHO). Eur. J. Haematol., 109 (6). S. 728 - 736. HOBOKEN: WILEY. ISSN 1600-0609

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Abstract

Objectives Patients with classical Hodgkin lymphoma (cHL) relapsing after second-line therapy have a dismal prognosis and novel approaches are required for this patient group. Based on promising (pre-)clinical data and the favourable toxicity profile, we performed a phase II clinical trial with the JAK inhibitor ruxolitinib in patients with relapsed or refractory cHL (r/r cHL). Methods Patients >= 18 years with histologically confirmed r/r cHL who failed second-line treatment were included. Ruxolitinib was given orally at a dose of 25 mg twice daily in continuous 28-day cycles until progression or unacceptable toxicity. Primary endpoint was the PET/CT-based overall response rate (ORR; complete response (CR) or partial response (PR)) after 2 cycles; secondary endpoints included progression-free (PFS) and overall survival (OS) as well as feasibility. The Jericho Trial adopted a 2-stage phase 2 design (Simon 1989). Results Among the 12 included patients in stage 1, 2 had a PR, 3 had a stable disease (SD) and 6 had progressive disease (PD) after two treatment cycles (ORR: 2/12 evaluable patients, 16.7%). Median PFS was 3.6 months, the 1-year OS estimate was 50.6% (median not reached). The toxicity profile was favourable with only one grade IV adverse event (7.1%) reported. Conclusion Ruxolitinib exhibited a favourable side effect profile but modest activity in r/r cHL. Although the formal stopping criterion after stage 1 was not met, the trial did not continue to stage 2 due to the low response and PFS rates observed in stage 1.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Gillessen, Sarah UNSPECIFIED UNSPECIFIED UNSPECIFIED Pluetschow, Annette UNSPECIFIED UNSPECIFIED UNSPECIFIED Vucinic, Vladan UNSPECIFIED orcid.org/0000-0002-8398-285X UNSPECIFIED Ostermann, Helmut UNSPECIFIED UNSPECIFIED UNSPECIFIED Kobe, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Broeckelmann, Paul J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Boell, Boris UNSPECIFIED UNSPECIFIED UNSPECIFIED Eichenauer, Dennis A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Heger, Jan-Michel UNSPECIFIED orcid.org/0000-0001-9463-8504 UNSPECIFIED Borchmann, Sven UNSPECIFIED UNSPECIFIED UNSPECIFIED Fuchs, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Borchmann, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Engert, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED von Tresckow, Bastian UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-678149
DOI:	10.1111/ejh.13859
Journal or Publication Title:	Eur. J. Haematol.
Volume:	109
Number:	6
Page Range:	S. 728 - 736
Date:	2022
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1600-0609
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language STEM-CELL TRANSPLANTATION; DOSE-INTENSIFICATION; BRENTUXIMAB VEDOTIN; CHEMOTHERAPY; EXPRESSION; INTENSITY; NIVOLUMAB; BLOCKADE; DISEASE Multiple languages Hematology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/67814