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:
CreatorsEmailORCIDORCID Put Code
Gillessen, SarahUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pluetschow, AnnetteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vucinic, VladanUNSPECIFIEDorcid.org/0000-0002-8398-285XUNSPECIFIED
Ostermann, HelmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kobe, CarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Broeckelmann, Paul J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boell, BorisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichenauer, Dennis A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heger, Jan-MichelUNSPECIFIEDorcid.org/0000-0001-9463-8504UNSPECIFIED
Borchmann, SvenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fuchs, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Borchmann, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Engert, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Tresckow, BastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
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:
KeywordsLanguage
STEM-CELL TRANSPLANTATION; DOSE-INTENSIFICATION; BRENTUXIMAB VEDOTIN; CHEMOTHERAPY; EXPRESSION; INTENSITY; NIVOLUMAB; BLOCKADE; DISEASEMultiple languages
HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/67814

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