Lenalidomide maintenance after initial immunochemotherapy in chronic lymphocytic leukaemia—Final analysis of the international phase III CLL6 RESIDUUM study of the ALLG and FILO groups

@article{aurranschleinitz2026lenalidomide,
  title = {{Lenalidomide maintenance after initial immunochemotherapy in chronic lymphocytic leukaemia—Final analysis of the international phase III CLL6 RESIDUUM study of the ALLG and FILO groups}},
  author = {Thérèse Aurran-Schleinitz and Rémi Letestu and Mary Sartor and Stephen Mulligan and Marie Béné and Gavin Cull and Dennis Carney and William Renwick and Andrew Grigg and Cecily Forsyth and Gregory Hapgood and Emma Verner and Rosemary Harrup and Pauline Warburton and Kylie Mason and Richard Eek and Wojciech Janowski and Jean Pierre Vilque and Maya Latimer and Laurent Voillat and Sophie de Guibert and Bernard Drenou and Robert Blum and Caroline Dartigeas and Lachlan Hayes and Nicolas Daguindau and Mourad Tiab and Véronique Leblond and Andrew Shearer and Masa Lasica and Pierre Morel and Bohrane Slama and Anne Banos and Annie Brion and Emmanuelle Ferrant and Jessica Michel and Cécile Tomowiak and Edward Morris and Hanlon Sia and Kelly Kratzing and Belinda Butcher and Abdelmalek Dahmani and Stephen Robert Larsen and Piers Blombery and Florence Cymbalista and David Gottlieb},
  journal = {British Journal of Haematology},
  year = {2026},
  month = sep,
  doi = {10.1111/bjh.70850},
  url = {https://u-picardie.hal.science/hal-05762914v1},
  note = {CC BY-NC},
}

TY  - JOUR
TI  - Lenalidomide maintenance after initial immunochemotherapy in chronic lymphocytic leukaemia—Final analysis of the international phase III CLL6 RESIDUUM study of the ALLG and FILO groups
AU  - Thérèse Aurran-Schleinitz
AU  - Rémi Letestu
AU  - Mary Sartor
AU  - Stephen Mulligan
AU  - Marie Béné
AU  - Gavin Cull
AU  - Dennis Carney
AU  - William Renwick
AU  - Andrew Grigg
AU  - Cecily Forsyth
AU  - Gregory Hapgood
AU  - Emma Verner
AU  - Rosemary Harrup
AU  - Pauline Warburton
AU  - Kylie Mason
AU  - Richard Eek
AU  - Wojciech Janowski
AU  - Jean Pierre Vilque
AU  - Maya Latimer
AU  - Laurent Voillat
AU  - Sophie de Guibert
AU  - Bernard Drenou
AU  - Robert Blum
AU  - Caroline Dartigeas
AU  - Lachlan Hayes
AU  - Nicolas Daguindau
AU  - Mourad Tiab
AU  - Véronique Leblond
AU  - Andrew Shearer
AU  - Masa Lasica
AU  - Pierre Morel
AU  - Bohrane Slama
AU  - Anne Banos
AU  - Annie Brion
AU  - Emmanuelle Ferrant
AU  - Jessica Michel
AU  - Cécile Tomowiak
AU  - Edward Morris
AU  - Hanlon Sia
AU  - Kelly Kratzing
AU  - Belinda Butcher
AU  - Abdelmalek Dahmani
AU  - Stephen Robert Larsen
AU  - Piers Blombery
AU  - Florence Cymbalista
AU  - David Gottlieb
PY  - 2026
DA  - 2026/09/20
JO  - British Journal of Haematology
DO  - 10.1111/bjh.70850
UR  - https://u-picardie.hal.science/hal-05762914v1
AB  - Most patients treated for chronic lymphocytic leukaemia (CLL) fail to achieve measurable residual disease (MRD) negativity. The role of maintenance with the immunomodulatory drug lenalidomide in these patients is unclear. A randomised multicentre phase III trial (ACTRN12610000060044) was conducted in Australia and France to assess the effect of 2 years of daily lenalidomide maintenance versus observation in patients with CLL and residual disease after initial immunochemotherapy. The primary end-point was time to disease progression or death from randomisation. Between May 2011 and January 2018, 143 patients were randomised to receive lenalidomide (n = 71) or observation (n = 72). Median progression-free survival (PFS) was longer with lenalidomide at 64.6 months (95% confidence interval [CI] 47.7 to not reached) versus 42.4 months (95% CI 32.3-61.6) in the observation arm (p = 0.039). Lenalidomide benefit persisted for 3 years after maintenance cessation. There was no difference in overall survival. More patients taking lenalidomide achieved MRD negativity, especially those who received at least 20 maintenance cycles. Lenalidomide led to more cytopenias, infections and gastrointestinal effects. There were no cases of acute lymphoblastic leukaemia. In patients with CLL selected by the presence of residual disease at the end of initial chemoimmunotherapy, lenalidomide maintenance increased the chance of achieving MRD negativity and prolonged PFS.
SN  - 0007-1048
SN  - 1365-2141
ER  -