Ibrutinib in Combination with Lenalidomide and Rituximab in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

• Research type

  Research Study

• Full title

  A Multicentre Open-Label Phase 1b/2, Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

• IRAS ID

  151105

• Contact name

  Kirit Ardeshna

• Contact email

  kirit.ardeshna@uclh.nhs.uk

• Sponsor organisation

  Pharmacyclics, Incorporated

• Eudract number

  2013-004341-17

• Research summary

  Diffuse large B-cell lymphoma (DLBCL) is a cancer of the white blood cells (called lymphocytes) that are found in the lymph nodes and affects the lymphatic system. The lymphatic system helps to fight infections and disease. DLBCL is the most common of the aggressive non-Hodgkin lymphomas (NHL).

  Pharmacyclics, Inc. is studying ibrutinib in combination with lenalidomide, with or without rituximab in participants with DLBCL. Ibrunitib (Imbruvica™) and lenalidomide (Revlimid®) have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma. Ibrutinib and lenalidomide have not been approved in any country for the treatment of DLBCL. Rituximab (Rituxan®) is approved by the U.S. FDA and European Medicines Agency for the treatment of patients with DLBCL and other diagnoses. The three study drugs ibrutinib, lenalidomide and rituximab are being combined for the first time in DLBCL.

  The study will be conducted in two Phases. Phase 1b will be an open-label study conducted in US only. The dose escalation portion of the study is designed to establish the maximum tolerated dose (MTD) of the ibrutinib, lenalidomide, and rituximab combination. Phase 2 will be a randomised, open-label study designed to evaluate the overall response rate of ibrutinib and lenalidomide, with and without rituximab, in relapsed or refractory non-GCB DLBCL participants ineligible for transplant.

  Approximately 137 participants, inclusive of Phase 1b and Phase 2, will be enrolled.
  The Phase 2 part of the study will be conducted at up to 70 international clinical centres, with approximately 110 participants (55 each treatment arm) enrolled. Both Phases will include a Screening Phase, Treatment Phase and a Follow-Up Phase.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  14/LO/1165

• Date of REC Opinion

  4 Aug 2014

• REC opinion

  Favourable Opinion