Table 1.
A summary of ongoing clinical trials of ibrutinib in CLL and MCL
| Drugs | Indication | Study phase | Study status | Trial identifiers | Location | Estimated completion date | Sponsor |
|---|---|---|---|---|---|---|---|
| Ibrutinib + carfilzomib | R/R MCL | I/II | Recruiting | NCT02269085 | Texas, USA | December 2017 | M.D. Anderson Cancer Center |
| Ibrutinib vs ibrutinib + rituximab | Relapsed CLL – randomized open-label crossover study to compare efficacy of R–I vs I | II | Recruiting | NCT02007044 | Texas, USA | December 2017 | M.D. Anderson Cancer Center |
| Lenalidomide, rituximab + ibrutinib | R/R CLL | I | Recruiting | NCT02200848 | Columbia, USA | June 2016 | Georgetown University, USA; NCI |
| Ibrutinib and palbociclib isethionate | Previously treated MCL | I | Recruiting | NCT02159755 | Multicenter, USA | February 2017 | NCI |
| Lenalidomide, ibrutinib | Relapsed, refractory CLL/SLL | I | Recruiting | NCT01886859 | Multicenter, USA | December 2015 | NCI |
| Ibrutinib, bendamustine, rituximab | R/R CLL/SLL HELIOS study | III | Active | NCT01611090 | Multicenter, international | March 2018 (primary completion, August 15) | Janssen Research & Development, LLC |
| Lenalidomide, ibrutinib, rituximab | R/R SLL/CLL | I | Recruiting | NCT02160015 | Columbia, USA | June 2015 | NCI |
| Ibrutinib, rituximab | R/R MCL | II | Active | NCT01880567 | Texas, USA | December 2019 | M.D. Anderson Cancer Center |
| Ibrutinib + rituximab vs FCR | Untreated CLL/SLL – IR vs FCR first line in younger patients | III | Recruiting | NCT02048813 | Multicenter, USA | April 2017 | NCI |
| Ibrutinib vs rituximab | R/R CLL/SLL | III | Recruiting | NCT01973387 | Multicenter, international | May 2016 | Janssen Research & Development, LLC |
| Ibrutinib maintenance post-induction | MCL – open-label single-arm study. Maintenance ibrutinib for up to 4 years | II | Recruiting | NCT02242097 | Multicenter, USA | June 2017 | Northwestern University, Janssen Scientific Affairs LLC, NCI |
| Ibrutinib vs temsirolimus | R/R MCL – RAY study | III | Active | NCT01646021 | International multicenter | November 2016 | Janssen Research & Development, LLC |
| Ibrutinib, rituximab, bendamustine | Older patients with previously untreated CLL – randomized open-label study of R–B vs R–I vs I alone | III | Recruiting | NCT01886872 | Multicenter, USA | March 2018 | NCI |
| Ibrutinib | MCL, CLL, SLL, FL, DLBCL – long-term extension safety/efficacy study | IIIb | Enrolling by invitation only | NCT01804686 | Multicenter, international | December 2019 | Janssen Research & Development, LLC |
| Ibrutinib, bendamustine, rituximab | Newly diagnosed MCL – randomized double-blind placebo-controlled trial SHINE study | III | Active, not recruiting | NCT01776840 | Multicenter, international | October 2019 | Janssen Research & Development, LLC |
| Ibrutinib vs chlorambucil | Treatment-naive patients >65 years with CLL/SLL RESONATE-2 | III | Ongoing but not recruiting | NCT01722487 | Texas, USA | February 2016 | Pharmacyclics, Janssen Research & Development, LLC |
| Ibrutinib vs chlorambucil | CLL/SLL >65 years – open-label extension of RESONATE-2 study | III | Enrolling by invitation only | NCT01724346 | Texas, USA | February 2018 | Pharmacyclics, Janssen Research & Development, LLC |
Abbreviations: R/R, relapsed/refractory; MCL, mantle cell lymphoma; CLL, chronic lymphocytic leukemia; IR, ibrutinib and rituximab; FCR, fludarabine, cyclophosphamide and rituximab; R, rituximab; I, ibrutinib; NCI, National Cancer Institute; SLL, small lymphocytic lymphoma; B, bendamustine; FL, follicular lymphoma; DLBCL, diffuse large B-cell lymphoma.