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Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study
D. Belada, K. Kopeckova, JM. Bergua Burgues, D. Stevens, M. André, EP. Persona, P. Pichler, PB. Staber, M. Trneny, J. Duell, M. Waldron-Lynch, S. Wagner, A. Mukhopadhyay, M. Dirnberger-Hertweck, JM. Burke, GS. Nowakowski
Jazyk angličtina Země Spojené státy americké
Typ dokumentu randomizované kontrolované studie, klinické zkoušky, fáze I, časopisecké články, práce podpořená grantem
Freely Accessible Science Journals od 1946 do Před 1 rokem
Open Access Digital Library od 1946-01-01
Open Access Digital Library od 1946-01-01
ROAD: Directory of Open Access Scholarly Resources
Elsevier Open Archive Journals od 1946 do Před 1 rokem
Odkazy
PubMed
37369099
DOI
10.1182/blood.2023020637
Knihovny.cz E-zdroje
- MeSH
- cyklofosfamid škodlivé účinky MeSH
- difúzní velkobuněčný B-lymfom * patologie MeSH
- dospělí MeSH
- doxorubicin škodlivé účinky MeSH
- lenalidomid terapeutické užití MeSH
- lidé MeSH
- myší monoklonální protilátky škodlivé účinky MeSH
- prednison škodlivé účinky MeSH
- protokoly antitumorózní kombinované chemoterapie škodlivé účinky MeSH
- rituximab škodlivé účinky MeSH
- vinkristin škodlivé účinky MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze I MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
Anti-CD19 immunotherapy tafasitamab is used in combination with lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant. Open-label, phase 1b, First-MIND study assessed safety and preliminary efficacy of tafasitamab + R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) ± lenalidomide as first-line therapy in patients with DLBCL. From December 2019 to August 2020, 83 adults with untreated DLBCL (International Prognostic Index 2-5) were screened and 66 were randomly assigned (33 per arm) to R-CHOP-tafasitamab (arm T) or R-CHOP-tafasitamab-lenalidomide (arm T/L) for 6 cycles. Primary end point was safety; secondary end points included end-of-treatment (EoT) overall response rate (ORR) and complete response (CR) rate. All patients had ≥1 treatment-emergent adverse event, mostly grade 1 or 2. Grade ≥3 neutropenia and thrombocytopenia occurred, respectively, in 57.6% and 12.1% (arm T) and 84.8% and 36.4% (arm T/L) of patients. Nonhematologic toxicities occurred at similar rates among arms. R-CHOP mean relative dose intensity was ≥89% in both arms. EoT ORR was 75.8% (CR 72.7%) in arm T and 81.8% (CR 66.7%) in arm T/L; best ORR across visits was 90.0% and 93.9%. Eighteen-month duration of response and of CR rates were 72.7% and 74.5% (arm T) and 78.7% and 86.5% (arm T/L); 24-month progression-free and overall survival rates were 72.7% and 90.3% (arm T) and 76.8% and 93.8% (arm T/L). Manageable safety and promising signals of efficacy were observed in both arms. Potential benefit of adding tafasitamab + lenalidomide to R-CHOP is being investigated in phase 3 frontMIND (NCT04824092). This study is registered at www.clinicaltrials.gov as #NCT04134936.
Bioaraba Vitoria Gasteiz Spain
Charles University General Hospital Prague Czech Republic
Department of Hematology Hospital San Pedro de Alcantara Cáceres Spain
Department of Hematology Université Catholique de Louvain CHU UCL Namur Yvoir Belgium
Department of Internal Medicine University Hospital of St Pölten St Pölten Austria
Division of Hematology Mayo Clinic Rochester MN
Medizinische Klinik und Poliklinik 2 Universitätsklinik Würzburg Würzburg Germany
Norton Cancer Institute St Matthews Campus Louisville KY
US Oncology Research and Rocky Mountain Cancer Centers Aurora CO
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