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

ConditionsLarge B-cell LymphomaCentral Nervous System Lymphoma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Golcadomide

    Drug

    To be taken orally daily on days 1-7 of the cycle Maximum 3 cycles but participants may received up to 3 additional cycles (for a total of up to 6 cycles) Cycle Length : 21 days Dose Levels: * Level -1 : 0.2milligrams/day * Level 1 : 0.2milligrams/day * Level 2 : 0.4milligrams/day

  • Pemetrexed

    Drug

    To be given intravenously (IV) on day 1 of each cycle Maximum 3 cycles but participants may receive up to 3 additional cycles (for a total of up to 6 cycles) Cycle Length: 21 days Dose Level * Level -1 : 675 milligrams/square meter * Level 1 : 900 milligrams/square meter * Level 2 : 900 milligram/square meter

  • Rituximab

    Drug

    To be given intravenously on day 1 of each cycle Maximum 3 cycles but participants may receive up to 3 additional cycles (for a total of up to 6 cycles) Cycle Length: 21 days Dose Level * Level -1 : 500 milligram/ square meter * Level 1 : 500 milligram/ square meter * Level 2 : 500 milligram/ square meter

  • Dexamethasone

    Drug

    To be given orally on days 1-4 of each cycle Day 1 dose should be given at least 30 minutes before rituximab infusion Maximum 3 cycles but participants may receive up to 3 additional cycles (for a total of up to 6 cycles) Cycle Length: 21 days Dose Level * Level -1 : 10 milligrams * Level 1 : 10 milligrams * Level 2 : 10 milligrams

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Golcadomide + Pemetrexed, Rituximab and DexamethasoneExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Safety of Golcadomide + Pemetrexed, Rituximab and Dexamethasone

Safety is defined as rates of adverse events experienced by participants. Adverse event severity is graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 6.0.

Time frame
up to 6 cycles (up to 6 months)
2

Identify the maximum tolerated dose of Golcadomide + Pemetrexed, Rituximab and Dexamethasone

determined by the 3+3 dose escalation design

Time frame
up to 6 cycles (up to 6 months)

Secondary outcomes

1

Overall response rate (ORR) by International Primary CNS Lymphoma Collaborative Group (IPCG) of Golca + PRD

ORR includes complete response (CR), Unconfirmed CR (CRu), partial response (PR), \& disease control rate (DCR), according to the 2005 IPCG Response Criteria. CR: complete disappearance of abnormalities on gadolinium-enhanced MRI, no contrast enhancement in brain imaging, no corticosteroid dose, normal eye examination \& negative Cerebrospinal fluid (CSF) cytology. CRu: fulfilling criteria for CR but with minimum to no contrast enhancement in brain imaging, continuing use of corticosteroid therapy, normal to minor retinal pigment epithelium (RPE) abnormality, \& negative CSF cytology. PR: greater than 50% decrease in contrast-enhancing lesion compared to baseline imaging, normal to minor RPE abnormality, negative CSF cytology \& no new sites of disease. SD: less than a PR but is not progressive disease.

Time frame
up to 18 months
2

Disease control rate (DCR) by IPCG

DCR is the percentage of participants whose cancer did not get worse after treatment (i.e. the percentage of participants who had CR, PR, or , SD, as defined below), and this will be measured by the IPCG response criteria. CR: complete disappearance of abnormalities on gadolinium-enhanced MRI, no contrast enhancement in brain imaging, no corticosteroid dose, normal eye examination \& negative Cerebrospinal fluid (CSF) cytology. CRu: fulfilling criteria for CR but with minimum to no contrast enhancement in brain imaging, continuing use of corticosteroid therapy, normal to minor retinal pigment epithelium (RPE) abnormality, \& negative CSF cytology. PR: greater than 50% decrease in contrast-enhancing lesion compared to baseline imaging, normal to minor RPE abnormality, negative CSF cytology \& no new sites of disease. SD: less than a PR but is not progressive disease.

Time frame
18 months
3

Overall survival rate

Overall survival (OS) is defined as the duration of time from start of treatment to time of death from any cause for participants who complete treatment.

Time frame
18 months
4

Progression free survival rate

Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first, for participants who complete treatment.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Allison Winter

Lead sponsor

Case Comprehensive Cancer Center

Sponsor institution

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov

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