Luster PCI32765FLR3001

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination with Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)

• IRAS ID

  142552

• Contact name

  Tobias Menne

• Contact email

  tobiasmenne@nhs.net

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2013-003093-27

• Clinicaltrials.gov Identifier

  NCT01974440

• Duration of Study in the UK

  7 years, 6 months, 0 days

• Research summary

  A randomized, double blind, placebo-controlled, multicenter, Phase 3 study to compare the efficacy and safety of ibrutinib in combination with bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) to BR alone or R-CHOP alone in subjects with previously treated indolent Non-Hodgkin Lymphoma (iNHL) either Follicular (FL) or Marginal Zone Lymphoma (MZL).
  The study includes a Screening Phase, Treatment Phase, and Post treatment Follow-up Phase.
  The Treatment Phase will extend from randomization until study drug discontinuation.
  Approximately 400 eligible subjects will be stratified by (1) background chemotherapy treatment, (2) refractory versus relapsed disease, (3) iNHL histology, and (4) number of prior therapies. Subjects will be randomized in a 1:1 ratio to Treatment Arm A (background chemotherapy + placebo) or Treatment Arm B (background chemotherapy + 560 mg of ibrutinib). Study drug is taken orally approximately 30 minutes before or approximately 2 hours after a meal once daily on a continuous schedule until disease progression, unacceptable toxicity, or study end, whichever comes first. The Post treatment Follow-up Phase will begin once a subject discontinues study drug (ibrutinib or placebo). Subjects who discontinue for reasons other than disease progression must continue disease evaluations according to the Time and Events Schedule. The Post treatment Follow-up Phase will continue until death, loss to follow up, consent withdrawal, or study end, whichever occurs first.
  Tumour response and progression will be conducted in accordance with the Revised Response Criteria for Malignant Lymphoma. The investigator will evaluate sites of disease by radiological imaging, physical examination, or other procedures as necessary. At each site visit, subjects will be evaluated for toxicity. Safety evaluations will include adverse event monitoring, physical examinations, concomitant medication usage, and clinical laboratory parameters. At some visits, blood samples will be taken for assessment of pharmacokinetic parameters and for minimal residual disease (MRD)

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  14/LO/0080

• Date of REC Opinion

  11 Mar 2014

• REC opinion

  Further Information Favourable Opinion