Golcadomide With Pemetrexed, Rituximab, and Dexamethasone for Relapsed and Refractory CNS Lymphomas

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAllison Winter

About this trial

This research study is for people who have been diagnosed with large B-cell lymphoma of the central nervous system (CNS), which has either returned or is not responding to current treatment. Goldcadomide is a new experimental drug that works by binding to a specific protein inside cancer cells and helps stimulate immune cells that help fight cancer cells. It also has the ability to enter the central nervous system. It has shown promising safety and effectiveness when combined with standard of care chemotherapy. Participants will be treated with this study drug combined with standard of care chemotherapy. Participation in the research will last about 2.5 years. The purpose of this study is to help researchers learn if the study drug, Golcadomide, in combination with the standard of care regimen is a safe and effective way to treat large B-cell lymphoma with CNS involvement.

Eligibility criteria

Qualifiers

Participants or their legally acceptable representative must have signed and dated an IRB approved written ICF in accordance with regulatory, local, and institutional guidelines.

Participants ≥ 18 years of age.

Large B-cell lymphoma NOS

Diffuse large B-cell lymphoma (including GCB and ABC types)

Disqualifiers

Prior treatment toxicities not resolved to grade < 2 according to NCI CTCAE 6.0 (with the exception of alopecia or grade 2 sensory peripheral neuropathy).

Participants receiving any other investigational agents.

History of anaphylactic reactions or severe allergic reactions prohibiting further administration attributed to compounds of similar chemical or biologic composition to rituximab or other agents used in this study.

Autologous stem cell transplant within 30 days of start of study drug (C1D1).

Trial design

Treatments tested in this trial

  • Golcadomide
  • Pemetrexed
  • Rituximab
  • Dexamethasone

Treatment groups

18 Participants
are divided into 1 treatment group

Sponsors and collaborators

Allison Winter

Lead sponsor

Case Comprehensive Cancer Center

Sponsor institution

Bristol-Myers Squibb

Collaborator