Gillessen, Sarah, Huettmann, Andreas, Vucinic, Vladan, Mueller, Horst, Pluetschow, Annette, Viardot, Andreas, Topp, Max S., Kobe, Carsten, Boell, Boris, Eichenauer, Dennis A. ORCID: 0000-0002-1927-3514, Sasse, Stephanie, Haverkamp, Heinz, Schmitz, Christine, Borchmann, Sven, Broeckelmann, Paul J., Heger, Jan-Michel, Fushs, Michael, Engert, Andreas, Borchmann, Peter and von Tresckow, Bastian (2022). Reinduction therapy with everolimus in combination with dexamethasone, high-dose cytarabin and cisplatinum in patients with relapsed or refractory classical Hodgkin lymphoma: an experimental phase I/II multicentre trial of the German Hodgkin Study Group (GHSG HD-R3i). Br. J. Haematol., 196 (3). S. 606 - 617. HOBOKEN: WILEY. ISSN 1365-2141

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Abstract

Reinduction chemotherapy followed by high-dose chemotherapy and autologous stem cell transplant (HDCT + ASCT) is second-line standard of care for transplant-eligible patients with relapsed/refractory classical Hodgkin lymphoma (r/r cHL) but has a high failure rate. Because response to reinduction is predictive of the outcome after HDCT + ASCT, we aimed to improve the standard dexamethasone, high-dose cytarabine and cisplatinum (DHAP) reinduction regimen by addition of the oral mammalian target of rapamycin inhibitor everolimus (everDHAP). Transplant-eligible patients aged 18-60 years with histologically confirmed r/r cHL were included in this experimental phase I/II trial. Everolimus (10 mg/day, determined in phase-I-part) was administered on day 0-13 of each DHAP cycle. From July 2014 to March 2018, 50 patients were recruited to the phase II everDHAP group; two were not evaluable, three discontinued due to toxicity. Randomization to a placebo group stopped in October 2015 due to poor recruitment after nine patients. The primary end-point of computed tomography (CT)-based complete remission (CR) after two cycles of everDHAP was expected to be >= 40%. With a CT-based CR rate of 27% (n = 12/45) after two cycles of everDHAP the trial did not meet the primary end-point. Adding everolimus to DHAP is thus feasible; however, the everDHAP regimen failed to show an improved efficacy.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Gillessen, SarahUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huettmann, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vucinic, VladanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, HorstUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pluetschow, AnnetteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Viardot, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Topp, Max S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kobe, CarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boell, BorisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichenauer, Dennis A.UNSPECIFIEDorcid.org/0000-0002-1927-3514UNSPECIFIED
Sasse, StephanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haverkamp, HeinzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmitz, ChristineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Borchmann, SvenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Broeckelmann, Paul J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heger, Jan-MichelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fushs, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Engert, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Borchmann, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Tresckow, BastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-594465
DOI: 10.1111/bjh.17878
Journal or Publication Title: Br. J. Haematol.
Volume: 196
Number: 3
Page Range: S. 606 - 617
Date: 2022
Publisher: WILEY
Place of Publication: HOBOKEN
ISSN: 1365-2141
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
STEM-CELL TRANSPLANTATION; POSITRON-EMISSION-TOMOGRAPHY; STUDY-GROUP HD7; BRENTUXIMAB VEDOTIN; SALVAGE THERAPY; PROGNOSTIC-FACTORS; INDUCED APOPTOSIS; ADAPTED TREATMENT; 2ND-LINE THERAPY; SINGLE-CENTERMultiple languages
HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/59446

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