Phase 1 trial patient characteristics and responses
| Pt . | Age/sex . | Original dx . | CNS lymphoma progression after prior therapies . | Response duration initial therapy, mo . | Initial dexamethasone dose/d . | On-study ECOG . | IOL status . | IOL response . | Brain status . | Brain response . | CSF status . | CSF response . | OR . | Overall PFS, mo . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 57/F | PCNSL/IOL | Initial: IF-RT | 9 | None | 1 | Yes | PR (L/R) | No | NA | No | NA | PR | 6 |
| (DLBCL) | Salvage: MT-R, pemetrexate, ASCT (Bu/Cy) | |||||||||||||
| Intraocular MTX + R | ||||||||||||||
| 2 | 63/M | PCNSL | Initial: MT-R, EA | 2 | None | 2 | No | NA | Yes | PD | No | NA | PD | 1 |
| (DLBCL) | ||||||||||||||
| 3 | 58/F | PCNSL | Initial: MT-R, EA | 18 | None | 1 | Yes | PR | No | NA | No | NA | PR | 21 |
| (DLBCL) | ||||||||||||||
| 4 | 69/F | PCNSL | Initial: MT-R, EA | 8 | None | 1 | Yes | CR | No | NA | No | NA | CR | 48+ |
| (DLBCL) | ||||||||||||||
| 5 | 68/F | PCNSL | Initial: MT-R | Primary refractory | 16 mg | 3 | No | NA | Yes | PR | Yes | CR | PR | 2.5 |
| (DLBCL) | Salvage: HD-MTX + R | |||||||||||||
| 6 | 47/F | Stage IV SCNSL | Initial: MT-R + CHOP + EA | 2 | None | 1 | Yes | SD | Yes | CR | Yes | SD | PR | 1.75 |
| (DLBCL) | ||||||||||||||
| 7 | 77/M | PCNSL | Initial: R-MPV, IT-MTX + HD-AraC | 7 | 8 mg | 2 | No | NA | Yes | PR | Yes | SD | PR | 1.5 |
| (DLBCL) | Salvage: ocular IF-RT, intraocular R | |||||||||||||
| MT-R, IF-RT | ||||||||||||||
| 8 | 54/F | PCNSL/IOL | Initial: MPV | 14 | None | 1 | Yes | PR | Yes | CR | No | NA | PR | 9 |
| (DLBCL) | Salvage: MT-R, HD-AraC, WBRT | |||||||||||||
| 9 | 70/F | SCNSL | Initial: R-EPOCH | 7 | 8 mg | 2 | No | NE | Yes | NE | Yes | NE | NE | NE |
| (DLBCL) | Salvage: R-DHAP, IFOS/VP16 | |||||||||||||
| ASCT (BEAM) | ||||||||||||||
| 10 | 64/F | SCNSL | Initial: R-MPV + WBRT + HD-AraC | 5 | None | 1 | No | NA | Yes | CR | No | NA | CR | 18 |
| (CLL + DLBCL) | ||||||||||||||
| 11 | 53/M | SCNSL | Initial: R-CHOP | 14 | 8 mg | 4 | No | NA | Yes | PD (mixed) | Yes | SD | PD | 1 |
| (DLBCL) | Salvage: MT-R, SRS, EA, HD-AraC | |||||||||||||
| 12 | 77/F | SCNSL | Initial: MT-R | Primary refractory | 8 mg | 2 | No | NA | Yes | PD | Yes | SD | PD | 3 |
| (DLBCL) | Salvage: IF-RT | |||||||||||||
| 13 | 79/M | SCNSL | Initial: R-CHOP + IF-RT | 12 | 4 mg | 2 | No | NA | No | NA | Yes | CR | CR | 13 |
| (CLL + DLBCL) | Salvage: R-Bendamustine | |||||||||||||
| 14 | 71/M | Stage IV | Initial: IV Rituximab | Primary refractory | None | 2 | No | NA | Yes | PR | No | NA | PR | 21+ |
| Marginal zone NHL | Salvage: R-CVP, FCR, R-bendamustine, HD-MTX |
| Pt . | Age/sex . | Original dx . | CNS lymphoma progression after prior therapies . | Response duration initial therapy, mo . | Initial dexamethasone dose/d . | On-study ECOG . | IOL status . | IOL response . | Brain status . | Brain response . | CSF status . | CSF response . | OR . | Overall PFS, mo . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 57/F | PCNSL/IOL | Initial: IF-RT | 9 | None | 1 | Yes | PR (L/R) | No | NA | No | NA | PR | 6 |
| (DLBCL) | Salvage: MT-R, pemetrexate, ASCT (Bu/Cy) | |||||||||||||
| Intraocular MTX + R | ||||||||||||||
| 2 | 63/M | PCNSL | Initial: MT-R, EA | 2 | None | 2 | No | NA | Yes | PD | No | NA | PD | 1 |
| (DLBCL) | ||||||||||||||
| 3 | 58/F | PCNSL | Initial: MT-R, EA | 18 | None | 1 | Yes | PR | No | NA | No | NA | PR | 21 |
| (DLBCL) | ||||||||||||||
| 4 | 69/F | PCNSL | Initial: MT-R, EA | 8 | None | 1 | Yes | CR | No | NA | No | NA | CR | 48+ |
| (DLBCL) | ||||||||||||||
| 5 | 68/F | PCNSL | Initial: MT-R | Primary refractory | 16 mg | 3 | No | NA | Yes | PR | Yes | CR | PR | 2.5 |
| (DLBCL) | Salvage: HD-MTX + R | |||||||||||||
| 6 | 47/F | Stage IV SCNSL | Initial: MT-R + CHOP + EA | 2 | None | 1 | Yes | SD | Yes | CR | Yes | SD | PR | 1.75 |
| (DLBCL) | ||||||||||||||
| 7 | 77/M | PCNSL | Initial: R-MPV, IT-MTX + HD-AraC | 7 | 8 mg | 2 | No | NA | Yes | PR | Yes | SD | PR | 1.5 |
| (DLBCL) | Salvage: ocular IF-RT, intraocular R | |||||||||||||
| MT-R, IF-RT | ||||||||||||||
| 8 | 54/F | PCNSL/IOL | Initial: MPV | 14 | None | 1 | Yes | PR | Yes | CR | No | NA | PR | 9 |
| (DLBCL) | Salvage: MT-R, HD-AraC, WBRT | |||||||||||||
| 9 | 70/F | SCNSL | Initial: R-EPOCH | 7 | 8 mg | 2 | No | NE | Yes | NE | Yes | NE | NE | NE |
| (DLBCL) | Salvage: R-DHAP, IFOS/VP16 | |||||||||||||
| ASCT (BEAM) | ||||||||||||||
| 10 | 64/F | SCNSL | Initial: R-MPV + WBRT + HD-AraC | 5 | None | 1 | No | NA | Yes | CR | No | NA | CR | 18 |
| (CLL + DLBCL) | ||||||||||||||
| 11 | 53/M | SCNSL | Initial: R-CHOP | 14 | 8 mg | 4 | No | NA | Yes | PD (mixed) | Yes | SD | PD | 1 |
| (DLBCL) | Salvage: MT-R, SRS, EA, HD-AraC | |||||||||||||
| 12 | 77/F | SCNSL | Initial: MT-R | Primary refractory | 8 mg | 2 | No | NA | Yes | PD | Yes | SD | PD | 3 |
| (DLBCL) | Salvage: IF-RT | |||||||||||||
| 13 | 79/M | SCNSL | Initial: R-CHOP + IF-RT | 12 | 4 mg | 2 | No | NA | No | NA | Yes | CR | CR | 13 |
| (CLL + DLBCL) | Salvage: R-Bendamustine | |||||||||||||
| 14 | 71/M | Stage IV | Initial: IV Rituximab | Primary refractory | None | 2 | No | NA | Yes | PR | No | NA | PR | 21+ |
| Marginal zone NHL | Salvage: R-CVP, FCR, R-bendamustine, HD-MTX |
Responses indicated were to lenalidomide monotherapy unless otherwise specified. Patient 10, who had systemic CLL with nodal involvement and documented brain parenchymal secondary CNS lymphoma (DLBCL), experienced stable peripheral lymphadenopathy with lenalidomide. Patient 13 had active leptomeningeal CLL plus concomitant DLBCL in CSF, as assessed by flow cytometry, and lymphoma in optic nerves, as assessed by MRI scan and neuroophthalmologic examinations. This patient’s systemic disease exhibited a PR to lenalidomide with >50% decrease in peripheral lymphocyte count compared with baseline counts prelenalidomide.
ASCT, autologous stem cell transplant; BEAM, BCNU, etoposide, cytarabine, melphalan; Bu/Cy, busulfan/cyclophosphamide; CHOP, cyclophosphamide, Adriamycin, vincristine, prednisone; dx, diagnosis; EA, etoposide/cytarabine; ECOG, Eastern Cooperative Oncology Group; F, female; FCR, fludarabine, cyclophosphamide, rituximab; HD-MTX + R, high-dose methotrexate plus rituximab; IF-RT, involved field radiotherapy; IFOS/VP16, ifosfamide/etoposide; IOL, intraocular lymphoma; IT, intrathecal; M, male; MT-R, high-dose methotrexate, temozolomide, rituximab; L, lenalidomide; NA, not applicable; NE, not evaluable; OR, overall response; Pt, patient; R, rituximab; R-CVP, rituximab, cyclophosphamide, vincristine, prednisone; R-DHAP, rituximab, dexamethasone, high-dose cytarabine, cisplatin; R-EPOCH, rituximab, etoposide, prednisone, vincristine, cyclophosphamide, Adriamycin; R-MPV, rituximab, methotrexate, prednisone, vincristine; SRS, stereotactic radiosurgery; WBRT, whole-brain radiotherapy.