Table 1.
Registered ongoing clinical trials for the treatment of PCNSL on ClinicaTrial.gov.
| Clinical trial number and study start time | Agents tested | Estimated enrollment | Trail setting | Primary endpoint | Ref. |
|---|---|---|---|---|---|
| NCT02315326 | Ibrutinib/ | 109 | A non-randomized phase I/II study | 1) The maximum tolerated dose (MTD) of ibrutinib (phase I) | Ref. (36) |
| Year: 2014 | Ibrutinib | R/R PCNSL | 2) PFS (phase II) | ||
| combined with HD-MTX | or SCNSL | 3) MTD of ibrutinib in combination with HD-MTX | |||
| NCT02203526 | 1) Ibrutinib | 68 | A phase I study | 1) MTD of ibrutinib when given with TEDD-R | Ref. (37) |
| Year: 2014 | 2) TEDDI-R | PCNSL | 2) Safety and feasibility in untreated PCNSL patients | ||
| 3) CR rate in untreated PCNSL patients | |||||
| 4) MTD of ibrutinib with anti-fungal prophylaxis when given with TEDD-R | |||||
| NCT04899427 | Orelabrutinib combined with PD-1 inhibitor | 32 | A prospective multicenter phase II study | ORR | / |
| Year: 2021 | R/R PCNSL | ||||
| NCT04831658 | Orelabrutinib combined with PD-1 and fotemustine | 40 | A prospective clinical study | CR rate | / |
| Year: 2021 | PCNSL | ||||
| NCT04401774 | PD-1/L1 inhibitor | 25 | An open-label phase II trial | 1) Frequencies of toxicities | / |
| Year: 2020 | (Nivolumab) | PCNSL | 2) cfDNA conversion rate in CSF | ||
| NCT04609046 | Lenalidomide combined with MTX, Rituximab, and Nivolumab (Nivo-MR2) | 27 | A phase I trial | 1) Maximum tolerated dose (MTD) | / |
| Year: 2021 | PCNSL | 2) Proportion of evaluable patients who are able to stay on maintenance therapy | |||
| NCT04443829 | CD19 CAR T cells | 12 | A single-center non-randomized, open-label phase I clinical trial | 1) Toxicity evaluated by the incidence of grade 3–5 toxicity causally related to the ATIMP | / |
| Year: 2021 | R/R PCNSL | 2) Feasibility of manufacturing CD19 CAR T cells evaluated by the number of therapeutic products generated | |||
| NCT04608487 | CD19 CAR T cells with Axicabtagene Ciloleucel (Axi-cel) | 18 | A phase I clinical trial | Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 | / |
| Year: 2020 | R/R PCNSL or SCNSL | ||||
| NCT04134117 | Tisagenlecleucel (CD19-targeted CAR T Cells) | 6 | A pilot study | Number of participants with treatment-related adverse events as assessed by CTCAE criteria and ASTCT 2018 (CRS/NT) | / |
| Year: 2019 | PCNSL | ||||
| NCT03484702 | JCAR017 | 116 | A single-arm, multi-cohort, multicenter, phase II study | 1) ORR of JCAR017 in subjects with non-Hodgkin lymphoma (NHL; including secondary central nervous system involvement) | / |
| Year: 2018 | aggressive B-cell non-Hodgkin lymphoma | 2) ORR of JCAR017 in R/R PCNSL | |||
| 3) AEs in subjects intended to be treated as outpatients |