A study of pembrolizumab following chemoimmunotherapy for primary central nervous system lymphoma

Conditions

None listed

Brief summary

The purpose of this study is to determine if a standard chemotherapy induction therapy followed by maintenance using pembrolizumab will be effective in maintaining life expectancy with minimal side effects for participants. Who is it for? You may be eligible for this study if you are an adult with has been diagnose with primary central nervous system lymphoma. Study details All participants in this study will complete a standard induction treatment followed by pembrolizumab, via a drip into the blood vessel, every 3 weeks for 2 years. Throughout the study scans will be performed at various time points such as Magnetic Reasonance imaging (MRI) and Positron Emission Tomography (PET scans) to take pictures inside your body. Blood samples will also be taken throughout the treatment period, however these are the same as you would have taken during standard treatment outside of the trial. It is hoped that this treatment will result in a better prognosis for those with primary central nervous system lymphoma, with less severe side effects.

Maciej Tatarczuch, Colm Keane, Christina Brown, Pratyush Giri, Gavin Cull et al. (13 authors)

Blood2024-11-051 citations

10.1182/blood-2024-200410

Interventions

Participants will receive an induction treatment of either a. Rituximab, Methotrexate, Procarbazine & Vincristine (R-MPV) Cytarabine (Ara-C) or b.Methotrexate, Cytarabine, Thiopeta & Rituximab (MATRix) Chemoimmunotherapy Induction Therapy (CIT) the induction treatment given is at the discretion of the participants clinician and is not assessed as part of this study. Once the induction treatment is complete participants will receive Pembrolizumab 200mg IV commencing 4-6 weeks after last CIT expo

Participants will receive an induction treatment of either a. Rituximab, Methotrexate, Procarbazine & Vincristine (R-MPV) Cytarabine (Ara-C) or b.Methotrexate, Cytarabine, Thiopeta & Rituximab (MATRix) Chemoimmunotherapy Induction Therapy (CIT) the induction treatment given is at the discretion of the participants clinician and is not assessed as part of this study. Once the induction treatment is complete participants will receive Pembrolizumab 200mg IV commencing 4-6 weeks after last CIT exposure and administered once every 3 weeks for 35 cycles / 2 years. At each Pembrolizumab clinical visit, the participant will be advised of their following appointment.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

Treatment-naïve new diagnosis of PCNSL (DLBCL) Age = greater than or equal to 18 years ECOG = less than or equal to 3 Considered appropriate for induction CIT as per investigator No standard contraindication to immune checkpoint inhibition

Exclusion criteria

Active autoimmune disease Unfit for induction CIT (prohibitive organ dysfunction) Non-B-cell lymphoma subtype Systemic involvement with aggressive lymphoma

Outcome results