Golcadomide + Standard Chemotherapy for Brain Lymphoma

AM
Overseen ByAllison M Winter, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Allison Winter
Must be taking: Methotrexate
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, Golcadomide, combined with standard chemotherapy to treat large B-cell lymphoma affecting the brain and spinal cord. Researchers aim to determine if this combination is safe and effective for individuals whose lymphoma has returned or is unresponsive to current treatments. The trial is open to those diagnosed with central nervous system lymphoma, who have tried at least one prior therapy, and are experiencing symptoms like brain or spine issues detected on an MRI. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, such as warfarin and strong CYP3A4/5 modulators, before starting the study drug. There is a washout period (time without taking these medications) of 7 days or 5 half-lives, whichever is longer, for strong CYP3A4/5 modulators.

Is there any evidence suggesting that Golcadomide combined with standard chemotherapy is likely to be safe?

Research has shown that Golcadomide has a promising safety record in early studies. This drug targets specific proteins in cancer cells, aiding the immune system in fighting the cancer. Studies have found it to be generally well-tolerated by patients, indicating that while some side effects may occur, they usually aren't severe enough to halt treatment.

However, Golcadomide has not yet received FDA approval for any condition. Although early results appear positive, further research is necessary to confirm its safety and effectiveness. As this study is in an early phase, it primarily focuses on identifying the safest dose levels and monitoring for side effects. Researchers will closely monitor participants for any adverse effects to ensure their safety during the trial.12345

Why do researchers think this study treatment might be promising?

Golcadomide is unique because it combines with standard chemotherapy agents like Pemetrexed, Rituximab, and Dexamethasone to tackle brain lymphoma more effectively. Unlike traditional treatments that primarily focus on one mechanism, Golcadomide may offer a novel method of action by potentially enhancing the effectiveness of these drugs. Researchers are excited because this combination has the potential to improve treatment outcomes and reduce the toxicities usually associated with high doses of chemotherapy.

What evidence suggests that Golcadomide combined with standard chemotherapy could be effective for brain lymphoma?

Research has shown that Golcadomide offers promising results for treating large B-cell lymphoma in the brain. In earlier studies, when combined with standard chemotherapy, Golcadomide led to a reduction in cancer size for 75% of patients. Additionally, 39% of patients achieved complete remission, with no signs of cancer detected. This trial will evaluate Golcadomide in combination with Pemetrexed, Rituximab, and Dexamethasone. Golcadomide targets specific proteins in cancer cells and boosts the immune system to combat the cancer. Its ability to penetrate the brain is particularly beneficial for treating brain lymphomas. These early findings suggest that Golcadomide could be a viable option for those whose cancer has returned or has not responded to other treatments.13567

Who Is on the Research Team?

AM

Allison M Winter, MD

Principal Investigator

Cleveland Clinic, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with large B-cell lymphoma in the brain or central nervous system that has come back or isn't responding to treatment. Participants should be adults whose cancer hasn't improved with standard therapies.

Inclusion Criteria

Participants or their legally acceptable representative must have signed and dated an IRB approved written ICF in accordance with regulatory, local, and institutional guidelines
I am 18 years old or older.
Women of childbearing potential must agree to remain abstinent or use two contraception methods (one highly effective and one barrier) from signing ICF through study and specified post-treatment periods, agree to pregnancy testing, and abstain from breastfeeding during and 28 days after golcadomide
See 11 more

Exclusion Criteria

Participants receiving other investigational agents
I have a serious autoimmune disease.
I have had a stem cell transplant from a donor.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Golcadomide in combination with Pemetrexed, Rituximab, and Dexamethasone to determine the maximum tolerated dose using a 3+3 dose escalation design

up to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including overall survival and disease control rate

18 months

Extension/Long-term follow-up

Participants may continue to be monitored for long-term outcomes such as progression-free survival and overall response rate

up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

  • Dexamethasone
  • Golcadomide
  • Pemetrexed
  • Rituximab

Trial Overview

The study tests Golcadomide, an experimental drug, combined with standard chemotherapy drugs (pemetrexed, rituximab, and dexamethasone) to see if this combination is safe and effective for treating relapsed or refractory CNS lymphoma.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Golcadomide + Pemetrexed, Rituximab and DexamethasoneExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Allison Winter

Lead Sponsor

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

Primary CNS Lymphoma - PMC - NIH

PCNSL have a poor prognosis, with median survival of 2 months without additional treatment.68 Median time to relapse is 10 to 18 months, and most relapses occur

Primary CNS Lymphoma Treatment (PDQ®) - NCI

Patients who received the two-drug combination had a complete remission rate of 23% (interquartile range [IQR], 14%‒31%; HR, 0.46; 95% CI, 0.28‒ ...

Outcomes for Primary Central Nervous System Lymphoma ...

Results: Of a total of 38 PCNSL patients, 6 died and 2 were lost to follow-up prior to therapy initiation, leading to a total of 30 patients for analysis. The ...

NCT07608731 | Golcadomide With Pemetrexed, Rituximab ...

It has shown promising safety and effectiveness when combined with standard of care chemotherapy. is a safe and effective way to treat large B- ...

Primary central nervous system lymphoma—current standards ...

The prognosis has improved in patients up to 70 years old, and this type of lymphoma can be potentially cured.

Primary central nervous system lymphoma - PMC

Primary central nervous system lymphoma (PCNSL) is a rare and aggressive extranodal non-Hodgkin lymphoma (NHL), confined to the brain, eyes, spinal cord or ...

How golcadomide works | Bristol Myers Squibb

Golcadomide is not currently approved in any market and has not been approved by the FDA as safe or effective for Non-Hodgkin Lymphoma