A randomized, open‐label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia

@article{Awan2014ARO,
  title={A randomized, open‐label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia},
  author={Farrukh T. Awan and Peter Hillmen and Andrzej Rafał Hellmann and Tadeusz Robak and Steve Hughes and Denise Trone and Megan Shannon and Ian W. Flinn and John C. Byrd},
  journal={British Journal of Haematology},
  year={2014},
  volume={167}
}
Lumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B‐cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open‐label… Expand
A phase I-II trial of fludarabine, bendamustine and rituximab (FBR) in previously treated patients with CLL
TLDR
Bine-elicited H2AX phosphorylation was not dose-dependent, but markedly increased after fludarabine, and bendamustine 30 mg/m2 was identified as the safe dose for phase II. Expand
An Evidence‐based Review of Anti‐CD20 Antibody‐containing Regimens for the Treatment of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Diffuse Large B‐cell Lymphoma, or Follicular Lymphoma
TLDR
The available data are inconclusive regarding any potential similarities or differences in efficacy among these anti‐CD20 agents for each respective disease, emphasizing the need for head‐to‐head randomized controlled trials of these drugs to inform clinical decision‐making for patients with relapsed or refractory B‐cell lymphoproliferative disorders. Expand
Obatoclax in combination with fludarabine and rituximab is well-tolerated and shows promising clinical activity in relapsed chronic lymphocytic leukemia
TLDR
It is concluded that obatoclax can be safely administered to relapsed CLL patients in combination with FR and shows promising clinical activity. Expand
Treatment of Relapsed and Refractory Chronic Lymphocytic Leukemia
  • T. Robak
  • Medicine
  • Hematologic Malignancies
  • 2019
TLDR
The management of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) has undergone significant changes during the last decade, and chemoimmunotherapy with fludarabine and cyclophosphamide with rituximab or ofatumumab in fit relapsed/refractory patients is more effective than FC alone. Expand
Targeted therapies for CLL: Practical issues with the changing treatment paradigm.
TLDR
Several ongoing phase III clinical trials with novel therapies will further define the role of targeted agents in CLL. Expand
A phase 1 clinical trial of flavopiridol consolidation in chronic lymphocytic leukemia patients following chemoimmunotherapy
TLDR
The study establishes the safety and efficacy of flavopiridol as consolidation therapy after chemoimmunotherapy for patients with CLL and further evaluation is required in larger trials for the utility of CDK inhibitors as consolidation or maintenance strategies. Expand
Skipping a step: what happened to the design of randomized clinical trials in chronic lymphocytic leukaemia?
  • L. Smolej
  • Medicine
  • British journal of haematology
  • 2020
TLDR
Future randomized trials in the current era of oral targeted agents should be carefully designed in a ‘step by step’ fashion which would provide the CLL community with simple yet robust answers regarding efficacy of novel regimens so that these can be introduced to practice following the best principles of evidence‐based medicine. Expand
Promising therapies for the treatment of chronic lymphocytic leukemia
TLDR
Newer compounds with different mechanisms of action, such as B-cell receptor signal transduction inhibitors, lenalidomide, next generation mAbs and several pro-apoptotic molecules, have shown efficacy in relapsed or refractory CLL patients. Expand
Antibody therapy alone and in combination with targeted drugs in chronic lymphocytic leukemia.
TLDR
Combinations of antibodies with targeted drugs like ibrutinib, idelalisib, or lenalidomide are expected to replace chemotherapy-based combinations for treating CLL in the near future, however, phase III trials should confirm the benefit of these new treatment strategies and establish their exact place in the therapeutic armamentarium for CLL. Expand
Monoclonal Antibodies in Chronic Lymphocytic Leukemia
TLDR
Technological advances relating to development of chimeric and humanized MoAbs are supporting the role of antibody-based regimens for many diseases, including CLL, and currently, MoAbs represent an integral component of CLL therapy. Expand
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TLDR
The addition of lumiliximab to FCR therapy is feasible, achieves a high CR rate, and does not appear to enhance toxicity in previously treated patients with CLL. Expand
Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia.
PURPOSE Rituximab, a monoclonal antibody that targets the CD20 cell surface antigen, has clinical activity in patients with non-Hodgkin's lymphoma and other B-lymphocyte disorders when administeredExpand
Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial
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Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab improves progression-free survival and overall survival in patients with chronic lymphocytic leukaemia, and the results suggest that the choice of a specific first-line treatment changes the natural course of chronic lymphocytes. Expand
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Chemoimmunotherapy with BR is effective and safe in patients with previously untreated CLL, and 90.5% of patients were alive. Expand
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TLDR
FCR produced a high CR rate in previously untreated CLL, and most patients had no detectable disease on flow cytometry at the end of therapy. Expand
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TLDR
Treatment with lumiliximab seemed to be well tolerated and to have clinical activity in patients with relapsed or refractory CLL. Expand
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TLDR
It was demonstrated that FC low-dose oral led to good responses in patients with CLL who do not benefit from a more aggressive schedule, with minimal toxicities, and this response was confirmed in a population of untreated elderly patients with low-grade NHL. Expand
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TLDR
In a multivariate analysis of patients receiving fludarabine-based therapy at the center, FCR therapy emerged as the strongest independent determinant of survival. Expand
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TLDR
The objective of the current analysis was to determine whether improvements in treatment have had an impact on survival for patients with CLL. Expand
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TLDR
The results indicate that the risk of therapy-related myeloid neoplasms secondary to frontline FCR therapy may not be as high as previously reported after removing the confounding factor of previous cytotoxic exposure, but this risk increased with older age and likely growth factor co-administration. Expand
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