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

LUCID trial investigators, Dina Ben-Yehuda-Salz

Research output: Contribution to journalArticlepeer-review

30 Scopus citations


Summary: 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, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty-seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression-free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL. © 2014 John Wiley & Sons Ltd.
Original languageEnglish
Pages (from-to)466-477
Number of pages12
JournalBritish Journal of Haematology
Issue number4
StatePublished - 2014

Bibliographical note

Cited By :27

Export Date: 3 October 2022


Correspondence Address: Awan, F.T.; Division of Hematology, B 307 Starling Loving Hall, 320 W. 10th Avenue, United States

Chemicals/CAS: cyclophosphamide, 50-18-0; fludarabine, 21679-14-1; lumiliximab, 357613-86-6; rituximab, 174722-31-7; vidarabine, 2006-02-2, 5536-17-4; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Cyclophosphamide; fludarabine; lumiliximab; rituximab; Vidarabine

Funding details: National Institutes of Health, NIH

Funding details: National Cancer Institute, NCI, P30CA016672

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  • CD23
  • Chronic lymphocytic leukaemia
  • Lumiliximab
  • Small lymphocytic lymphoma
  • cyclophosphamide
  • fludarabine
  • lumiliximab
  • rituximab
  • antineoplastic agent
  • monoclonal antibody
  • vidarabine
  • adult
  • aged
  • Article
  • autoimmune hemolytic anemia
  • autoimmune thrombocytopenia
  • bronchitis
  • cancer survival
  • cause of death
  • chronic lymphatic leukemia
  • controlled study
  • drug dose escalation
  • drug efficacy
  • drug safety
  • drug tolerability
  • drug withdrawal
  • febrile neutropenia
  • female
  • human
  • incidence
  • leukemia relapse
  • leukopenia
  • major clinical study
  • male
  • multicenter study
  • multiple cycle treatment
  • nausea
  • overall survival
  • pancytopenia
  • phase 2 clinical trial
  • phase 3 clinical trial
  • pneumonia
  • priority journal
  • progression free survival
  • randomized controlled trial
  • rhinopharyngitis
  • sinusitis
  • treatment response
  • tumor lysis syndrome
  • upper respiratory tract infection
  • urinary tract infection
  • very elderly
  • analogs and derivatives
  • clinical trial
  • comparative study
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • middle aged
  • recurrent disease
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Murine-Derived
  • Antineoplastic Combined Chemotherapy Protocols
  • Cyclophosphamide
  • Female
  • Humans
  • Male
  • Middle Aged
  • Recurrence
  • Vidarabine


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