drugset / Trial / NCT02315326
Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Patients With Newly Diagnosed or Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL) and Refractory/Recurrent Secondary Central Nervous System Lymphoma (SCNSL)
Phase 1/2
Completed
93 enrolled
Memorial Sloan Kettering Cancer Center
Janssen Biotech, Inc. · collabPharmacyclics LLC. · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to test any good or bad effects of the study drug called of ibrutinib (also known as Imbruvica™). At this stage of this trial, the study is investigating whether Ibrutinib can be incorporated into the established first-line chemotherapy regimen rituximab, methotrexate, vincristine, and procarbazine (R-VMP) in order to further refine the first-line induction therapy for PCNSL, as observed by a superior CRR (complete response rate) (ARM D RECRUITING ONLY)
Timeline
- Start
- 2014-12-08
- Primary completion
- 2026-01-28
- Completion
- 2026-01-28
Publications
- Krebs S, Mauguen A, Yildirim O, Hatzoglou V, Francis JH, Schaff LR, Mellinghoff IK, Schoder H, Grommes C. Prognostic value of [18F]FDG PET/CT in patients with CNS lymphoma receiving ibrutinib-based therapies. Eur J Nucl Med Mol Imaging. 2021 Nov;48(12):3940-3950. doi: 10.1007/s00259-021-05386-0. Epub 2021 May 8.
- Grommes C, Tang SS, Wolfe J, Kaley TJ, Daras M, Pentsova EI, Piotrowski AF, Stone J, Lin A, Nolan CP, Manne M, Codega P, Campos C, Viale A, Thomas AA, Berger MF, Hatzoglou V, Reiner AS, Panageas KS, DeAngelis LM, Mellinghoff IK. Phase 1b trial of an ibrutinib-based combination therapy in recurrent/refractory CNS lymphoma. Blood. 2019 Jan 31;133(5):436-445. doi: 10.1182/blood-2018-09-875732. Epub 2018 Dec 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 420 mg | Oral |
| Subject | Ibrutinib | Small molecule | 560 mg | Oral |
| Subject | Ibrutinib | Small molecule | 840 mg | Oral |
| Background | Methotrexate | Small molecule | 3.5 mg/m2 | — |
| Background | Rituximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Background | procarbazine | Small molecule | 100 mg/m2 | Oral |