Trials / Completed
CompletedNCT03703167
Ibrutinib With Rituximab and Lenalidomide for Patients With Recurrent/Refractory Primary or Secondary Central Nervous System Lymphoma (PCNSL/SCNSL)
Phase Ib Trial With Dose Expansion of the Bruton"s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab and Lenalidomide in Patients With Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL) and Refractory/Recurrent Secondary Central Nervous System Lymphoma (SCNSL)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The investigator's want to find out if treatment with ibrutinib, rituximab, and lenalidomide are safe and better than the usual approach in patients with recurrent or refractory central nervous system lymphoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ibrutinib | Oral ibrutinib will be given between days 1 and 28 of each 28-day cycle and will be continued daily after completion of rituximab and lenalidomide. The starting dose of ibrutinib is 560 mg/day (dose level 1) and (dose level 2 ibrutinib: 840 mg daily). |
| DRUG | Lenalidomide | Oral lenalidomide will be given between days 1 and 21 of each 28-day cycle for a maximum of 12 cycles. The starting dose of lenalidomide is 10 mg/day (dose level 1 \& 2) lenalidomide: 15 mg daily (dose level 3) and lenalidomide: 20 mg daily (dose level 4). |
| DRUG | Rituximab | Intravenous rituximab (500mg/m2) will be given on day 1 of all cycles (+/- 3 days), for up to 6 cycles. |
Timeline
- Start date
- 2019-01-22
- Primary completion
- 2026-01-26
- Completion
- 2026-01-26
- First posted
- 2018-10-11
- Last updated
- 2026-01-29
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03703167. Inclusion in this directory is not an endorsement.