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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Allison Winter
Study ID
NCT07608731
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Central Nervous System Lymphoma
  • Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Apr 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Golcadomide + Pemetrexed, Rituximab and Dexamethasone
    A 3+3 design will be used to identify the recommended phase 2 dose of Golcadomide in combination with Pemetrexed, Rituximab, and Dexamethasone. 3 participants will be enrolled in the first dose level. If these participants do not experience any dose limiting toxicities, then 3 more patients will be enrolled in the next dose level. If one or more participants experience dose limiting toxicities, then this dose will be considered the highest dose administered dose and 3 additional patients will be enrolled in the next lowest dose level. If 2 or more patients experience dose limiting toxicities, then the dose escalation will be stopped and 3 additional patients will enrolled in the next lowest dose level.

Primary Outcome Measure

Safety of Golcadomide + Pemetrexed, Rituximab and Dexamethasone [ Time Frame: up to 6 cycles (up to 6 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic, Case Comprehensive Cancer CenterClevelandOhio44122
Allison M Winter, MD
[email protected]
(216) 445-4635
Allison Winter, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cleveland Clinic, Case Comprehensive Cancer Center· Cleveland, OH

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