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

NCT07608731 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Golcadomide

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

DRUG

Pemetrexed

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

DRUG

Rituximab

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

DRUG

Dexamethasone

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

Sponsors & Collaborators

Principal Investigators

  • Allison M Winter, MD · Cleveland Clinic, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-04-30
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07608731 on ClinicalTrials.gov