Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
25/11/2016
Funder:
Cancer Research UK and HOVON
Sponsor:
UCL
Chief Investigator:
Dr Kim Linton (UK) / Dr Marie-Jose Kersten (NL)
Recruitment target:
80
EudraCT number:
2011-000097-56
Contact details:
ctc.rebel@ucl.ac.uk
Lay summary:
ReBeL
ReBeL study: a randomized phase I/II trial of lenalidomide and rituximab with or without bendamustine in patients >= 18 years with relapsed follicular lymphoma. A HOVON/GLSG/NCRI study
Description
Design: ReBeL is a prospective, randomised, multicentre, international phase II trial (phase I is not being conducted in the UK). ReBeL has two experimental arms; lenalidomide and rituximab versus lenalidomide, rituximab and bendamustine; the most promising of which will be taken on to a large randomised phase III trial. 
Treatment: Patients will receive 6 induction cycles of lenalidomide in combination with rituximab with or without bendamustine, followed by 2 years of maintenance treatment rituximab, once every three months. Patients will be followed up every 6 months thereafter, up to 8 years post registration.
Key inclusion/exclusion criteria:

Inclusion criteria
  • Age ≥18 years
  • WHO 0-2
  • Relapsed follicular lymphoma (FL) grade 1, 2, 3a
  • Ann Arbor staged II-IV at relapse
  • Biopsy showing CD20 positivity, measurable disease, suitable blood parameters
  • Maximum 5 prior systemic treatment regimens (with exceptions)
  • Prior bendamustine allowed (under certain conditions)

Exclusion criteria
  • Rituximab-refractory patients 
  • Clinical/histologic signs of transformation or prior transformed phase of FL
  • Prior allogeneic stem cell transplant (SCT)
  • Autologous SCT
  • Prior use of lenalidomide
  • Concurrent use of allopurinol
  • Hep B or C positive, HIV postive
  • Pregnant or lactating women
  • Uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP)
  • Active fungal, bacterial, and/or viral infection
  • Yellow fever vaccination (within 4 weeks)
  • Intolerance of exogenous protein administration, known allergy to murine
  • Uncontrolled hyperthyroidism/hypothyroidism
  • Neuropathy grade 2
  • Severe cardiac dysfunction (NYHA III-IV), severe pulmonary dysfunction
  • Active malignancy during past 5 years (with exceptions)

Duration of recruitment: 3 years
Aim
Currently there is no standard treatment for patients with relapsed FL. Lenalidomide, rituximab and bendamustine have shown promising activity in FL, both in first line and in relapse. Since the toxicity of all drugs is relatively minor and in part non-overlapping, combination of these drugs is an attractive option. The main aim of the study is to determine the efficacy and toxicity of the two arms of treatments in patients with relapsed FL.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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