Golcadomide + Rituximab for Mantle Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the safety and effectiveness of a new treatment combination for individuals with mantle cell lymphoma, a cancer affecting white blood cells that has either recurred or resisted treatment. The study tests golcadomide, which may inhibit cancer cell growth, and rituximab, an antibody that aids the immune system in combating cancer cells. Participants will receive these treatments to evaluate their combined efficacy. This trial may suit those with mantle cell lymphoma unresponsive to other treatments and who are willing to undergo regular testing and treatment cycles for up to 24 months. As a Phase 1, Phase 2 trial, the study focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.
Do I need to stop my current medications to join the trial?
The trial requires that you stop taking strong CYP3A4 inducers or inhibitors and herbal medications at least 14 days before starting the study. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that golcadomide, particularly when combined with rituximab, is generally well-tolerated by patients. In studies, most patients did not experience severe side effects, though some encountered significant blood-related issues. Specifically, 64% of patients experienced serious cases of neutropenia, a condition characterized by a low count of white blood cells crucial for fighting infections.
Despite these concerns, the combination has shown promise in treating certain types of lymphoma. While there are risks, golcadomide with rituximab may be safe for many patients. It is important to weigh these potential side effects against the benefits when considering participation in a trial.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for mantle cell lymphoma, which usually include chemotherapy and targeted therapies like ibrutinib, the combination of Golcadomide and Rituximab introduces a unique approach. Golcadomide, an oral medication, provides a new mechanism by potentially modulating the immune system to target cancer cells, while Rituximab, a well-known monoclonal antibody, enhances this effect by directly attacking lymphoma cells. This dual-action strategy not only aims to improve treatment outcomes but also could offer a more tailored and potentially less toxic alternative to traditional chemotherapy. Researchers are particularly excited about the possibility of achieving better control over the disease with fewer side effects.
What evidence suggests that golcadomide and rituximab could be effective for mantle cell lymphoma?
Studies have shown that golcadomide, particularly when combined with rituximab, yields promising results in treating mantle cell lymphoma that has recurred or is resistant to treatment. In this trial, participants in the Phase I arm will receive golcadomide alone, while those in the Phase II arm will receive the combination of golcadomide and rituximab. Previous patients experienced lasting improvements, with an average duration of 22 months. In some studies, this combination treatment helped 92% of patients, with 68% experiencing complete disappearance of cancer signs. Rituximab is well-known for extending the lives of people with lymphoma by aiding the immune system in attacking cancer cells. This suggests that the combination could effectively treat this challenging cancer.16789
Who Is on the Research Team?
Tycel J Phillips
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with mantle cell lymphoma that has come back after treatment or hasn't responded to previous therapies. Participants should be in generally stable health and able to undergo study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Patients receive golcadomide orally once daily on days 1-14 of each 28-day cycle, with blood sample collection and PET/CT scans.
Phase II Treatment
Patients receive golcadomide orally once daily on days 1-14 and rituximab intravenously on specified days of each 28-day cycle, with blood sample collection and PET/CT scans.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then up to 3 years.
What Are the Treatments Tested in This Trial?
Interventions
- Golcadomide
- Rituximab
Trial Overview
The study is testing a combination of two drugs, golcadomide and rituximab, to find the safest dose and see how well they work together against relapsed or refractory mantle cell lymphoma. Various scans and biopsies are also part of the trial.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients receive golcadomide PO QD on days 1-14 of each cycle. Patients also receive rituximab IV on days 1, 8, 15 and 22 of cycle 1 and then day 1 of even cycles. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and PET/CT throughout the trial. Patients undergo bone marrow biopsy and may undergo tissue biopsy on study.
Patients receive golcadomide PO QD on days 1-14 of each cycle. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and PET/CT throughout the trial. Patients undergo bone marrow biopsy and may undergo tissue biopsy on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Golcadomide in Combination With Rituximab for the ...
Giving golcadomide in combination with rituximab may better treat patients with relapsed or refractory mantle cell lymphoma. Detailed ...
2.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/3018/533620/Golcadomide-GOLCA-Rituximab-RTX-DemonstratesGolcadomide (GOLCA) ± Rituximab (RTX) Demonstrates ...
Responses were durable, with median DOR of 22 mo (range, 2-51) at a median follow up of 30 mo. 33% of pts (4/12) have completed 2 yrs of protocol defined GOLCA ...
Bristol Myers Squibb Advances Lymphoma Research with ...
“The data presented at ASH represent a significant step forward in our pursuit of transformative outcomes for patients with lymphoma, who ...
Evolving treatment patterns and improved outcomes in ... - PMC
The estimated 2-year EFS rate was 21% (95% CI, 13–35), 40% (95% CI, 30–53), and 51% (95% CI, 37–68) in Era 1–3 respectively, and the 5-year OS ...
GOLCADOMIDE (GOLCA), A CEREBLON E3 LIGASE ...
At 0.4mg, 8 pts had response >12 mo, including 3 with prior T-cell-directed Tx and 4 with prior len. Immunophenotyping confirmed immune ...
6.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/1006/554540/Golcadomide-GOLCA-a-potential-first-in-class-oralGolcadomide (GOLCA), a potential, first-in-class, oral ...
GOLCA is a potential, first-in-class, oral CELMoD agent designed for the treatment of lymphoma, with preferential distribution to lymphoid organs and enhanced ...
7.
library.ehaweb.org
library.ehaweb.org/eha/2024/eha2024-congress/419219/julio.chavez.safety.and.efficacy.of.golcadomide.a.potential.first-in-class.htmlSAFETY AND EFFICACY OF GOLCADOMIDE, A ...
SAFETY AND EFFICACY OF GOLCADOMIDE, A POTENTIAL FIRST-IN-CLASS CELMOD AGENT ± RITUXIMAB IN A PHASE 1/2 OPEN-LABEL STUDY OF PATIENTS WITH RELAPSED/REFRACTORY ...
Golcadomide (GOLCA), a potential, first-in-class, oral ...
Approximately one-third of the treated patients were exposed to prior T-cell–redirecting therapy, approximately one-third had prior lenalidomide (len) exposure, ...
9.
ctv.veeva.com
ctv.veeva.com/study/golcadomide-and-nivolumab-in-patients-with-non-hodgkin-lymphoma-with-refractory-disease-after-chimerGolcadomide and Nivolumab in Patients With Non-Hodgkin ...
In this combined phase I/II, open label, single arm trial to study, the safety and efficacy of combination Golcadomide and nivolumab in patients with ...
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