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The CLL2-BIO trial
from AbbVie, Acerta, AstraZeneca, Janssen-Cilag and Novartis, as well as travel grants from AbbVie, F. Hoffmann LaRoche, Gilead, Janssen-Cilag and Mundipharma. JvT reports research funding from F. Hoffmann-LaRoche and Janssen-Cilag, honoraria for advisory boards from AbbVie, F. Hoffmann-LaRoche and Janssen-Cilag, as well as travel grants from Celgene, F. Hoffmann-LaRoche and Janssen-Cilag. JB reports honoraria and travel grants from F. Hoffmann-LaRoche. PL reports research funding from AbbVie, F. Hoffmann-LaRoche and Janssen-Cilag, honoraria from Janssen-Cilag and travel grants from F. Hoffmann-LaRoche, Janssen-Cilag and Mundipharma. OA-S reports personal fees from F. Hoffmann- LaRoche, AbbVie and Gilead. WH reports research funding from MSD (Merck Sharp & Dohme) and Pfizer, honoraria for scientific talks from Alexion, Basilea, Gilead, MSD (Merck Sharp & Dohme) and Pfizer, advisory boards from Gilead Science, MSD, Pfizer, travel grants from Alexion, Astellas, Basilea, Gilead Science, MSD and Pfizer (all outside the sub- mitted work). UVK reports honoraria for advisory boards from AbbVie, Amgen, F. Hoffmann-LaRoche, Gilead, Lilly and MSD. JD reports honoraria for scientific talks from F. Hoffmann-LaRoche, Janssen-Cilag, Celgene; advisory boards from AbbVie, Amgen, Bristol-Myers Squibb, Janssen-Cilag, Novartis, Gilead; travel grants from Celgene, F. Hoffmann LaRoche, Gilead, Janssen-Cilag, and Mundipharma. ET reports travel grants from Abbvie, Celgene and Gilead. MHe reports honoraria for advisory boards from AbbVie and F. Hoffmann-LaRoche, and travel grants from AbbVie and F. Hoffmann-LaRoche. AMF reports research grants from Celgene and travel grants from AbbVie, F. Hoffmann-LaRoche and Mundipharma. KF reports travel grants from F. Hoffmann- LaRoche. KAK reports research support and honoraria for con- sultancy or advisory boards from AbbVie, F. Hoffmann-LaRoche and Mundipharma. SB reports grants and personal fees from AbbVie, F-Hoffmann-LaRoche and Janssen, grants from Celgene and Genentech, and personal fees from Becton Dickinson and Novartis. MR reports research funding from AbbVie, Amgen, F. Hoffmann-LaRoche and Gilead. MK reports honoraria for consultancy or advisory boards from AbbVie and F. Hoffmann-LaRoche. CMW reports research sup- port, honoraria for consultancy or advisory boards and travel
support from AbbVie, F. Hoffmann-LaRoche, Genentech, Gilead, GlaxoSmithKline, Janssen-Cilag, Mundipharma and Pharmacyclics. SS reports research support, honoraria for con- sultancy or advisory boards and travel support from AbbVie, Amgen, Celgene, F. Hoffmann-LaRoche, Genentech, Gilead, GlaxoSmithKline, Janssen-Cilag, Mundipharma, Novartis and Pharmacyclics. BE reports research support and honoraria for consultancy or advisory boards from AbbVie and F. Hoffmann- LaRoche. MHa reports research support and honoraria from Roche, Gilead, Mundipharma, Janssen, Celgene, Pharmacyclics and Abbvie. NP, SR and MF report no conflicts of interest.
Contributions
PC, JvT, JB, SB, BE and MH were responsible for the concep- tion and design of the study; PC, JvT, SR, JB, MF, PL, NP, OA- S, AMF and KF were responsible for the trial management; PC, JvT, MF, PL, NP, OA-S, WH, UV-K, JD, ET, MHe, SS, SB, MR, MK, CMW, SS, BE and MH were responsible for the recruitment and treatment of patients; PC, JvT, SR, JB, MF, PL and NP had access to the raw data; PC, MF, PL and NP per- formed a central review of all clinical data; ET, KAK, SB, MR, MK and SS performed the laboratory analyses; SR and JB per- formed the statistical analysis. All authors interpreted the data; PC wrote the first draft of the manuscript and all authors approved the final manuscript.
Acknowledgments
The CLL2-BIO trial is an investigator-initiated trial with the University of Cologne being the legal sponsor. Financial support was provided by the pharmaceutical company Novartis and the study drugs were provided by Novartis and Janssen-Cilag.
The authors wish to express their gratitude towards all patients participating in the trial, as well as the physicians and trial staff at the sites. We also thank the study management team with the project managers Tanja Annolleck, Johanna Wesselmann, Jana Kalz, and Miriam Schüler-Aparicio, the safety managers Sabine Frohs, and Tanja Annolleck, the data managers Viktoria Monar, Olga Korf, Florian Drey, Irene Stodden and Swetlana Dubnov, and Dr. Birgit Fath and the monitors from the “competence network, malignant lymphoma” (“Kompetenznetz Maligne Lymphome”).
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