Varghese, A, Howard, DR orcid.org/0000-0003-3333-9783, Pocock, C et al. (9 more authors) (2017) Eradication of minimal residual disease improves overall and progression free survival in patients with chronic lymphocytic leukaemia, evidence from NCRN CLL207: A Phase II trial assessing alemtuzumab consolidation. British Journal of Haematology, 176 (4). pp. 573-582. ISSN 0007-1048
Abstract
With immunochemotherapy, remission duration and survival in patients with CLL is dependent on the level of minimal residual disease after treatment. This phase II trial assessed alemtuzumab consolidation post-chemotherapy in patients who responded with persistent low levels of detectable disease. Blood was screened for MRD using multi-parameter flow cytometry, 6 to 24 months post-chemotherapy. MRD-positive participants received alemtuzumab 30mg subcutaneously 3 times weekly for 6 weeks. Following a marrow assessment, MRD-negative participants or non-responders stopped therapy and MRD-positive participants with 1+ log reduction had 6 more weeks of alemtuzumab. Alemtuzumab consolidation was received by 47 participants. One death and 19 of 22 serious adverse events reported from 17 (36%) participants were alemtuzumab related. MRD eradication from blood and bone marrow was achieved in 39 (83%) participants at the end of consolidation, with 18 (38%) remaining MRD-negative in the blood 6 months later. Of the 18 MRD-negative participants at 6 months, the median time to MRD relapse was 46 months which was similar to patients who were MRD-negative at baseline and were followed up. The 5-year PFS and OS of MRD-negative participants at 6 months was significantly better than MRD-positive participants (PFS: 78%vs39% (p=0.010), OS: 89%vs64% (p=0.029)).
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2016 John Wiley & Sons Ltd. This is the peer reviewed version of the following article: Varghese, A. M., Howard, D. R., Pocock, C., Rawstron, A. C., Follows, G., McCarthy, H., Dearden, C., Fegan, C., Milligan, D., Smith, A. F., Gregory, W., Hillmen, P. and NCRI CLL Sub-Group (2016), Eradication of minimal residual disease improves overall and progression-free survival in patients with chronic lymphocytic leukaemia, evidence from NCRN CLL207: a phase II trial assessing alemtuzumab consolidation. British Journal of Haematology. doi: 10.1111/bjh.14342, which has been published in final form at https://doi.org/10.1111/bjh.14342. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving. |
Keywords: | Chronic lymphocytic leukaemia; minimal residual disease; alemtuzumab |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > Institute of Molecular Medicine (LIMM) (Leeds) > Section of Experimental Haematology (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 28 Jul 2016 14:11 |
Last Modified: | 29 Dec 2017 01:38 |
Published Version: | https://doi.org/10.1111/bjh.14342 |
Status: | Published |
Publisher: | Wiley |
Identification Number: | 10.1111/bjh.14342 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:103031 |