Actively Recruiting
Phase 2 Study of Golcadomide With Rituximab as a Bridging Therapy Before CAR-T for Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
Led by Mayo Clinic · Updated on 2026-01-28
41
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of golcadomide and rituximab as a bridging treatment before chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive B-cell non-Hodgkin lymphoma that has returned after improvement or has not responded to past treatments. This phase II trial aims to see if this combination can better control the disease and increase the chance of patients qualifying for CAR T-cell therapy, which has potential for cure but is limited to some patients. Golcadomide may block cancer cell growth, while rituximab targets a protein on B cells to help the immune system kill cancer cells. Participants receive golcadomide orally once daily on days 1 to 14 of each 28-day cycle and rituximab intravenously on days 1, 8, 15, and 22 during the first cycle, then on day 1 of subsequent cycles. After two cycles, patients eligible for CAR T-cell therapy undergo leukapheresis and may receive one to two additional cycles before CAR T-cell treatment. Those not eligible continue golcadomide and rituximab for up to 10 and 3 more cycles respectively, unless the disease progresses or side effects occur. Throughout the study, patients have blood samples collected and undergo PET/CT or CT scans, with bone marrow tests as needed. Participants are closely monitored with scans and laboratory tests during and after treatment. After completing study treatment, all patients have a follow-up visit at 28 days. Those not receiving CAR T-cell therapy are followed every three months until disease progression or new treatment, then every six months for up to two years. Patients who undergo CAR T-cell therapy are followed at 180 days post-treatment and then every six months for up to two years. The main outcome measured is disease control after two cycles, with additional assessments of response rates, survival, and safety over two years.
CONDITIONS
Brief Title
Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of relapsed, progressive, or refractory aggressive B-cell non-Hodgkin lymphoma following one or two prior standard therapies, including specific subtypes such as diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and others as listed
- Measurable disease by PET-CT with at least one lesion greater than 1.5 cm in diameter
- Potential eligibility for CAR T-cell therapy as determined by treating physician
- ECOG performance status of 0, 1, or 2
- Hemoglobin level greater than 7.0 g/dL within 14 days prior to registration
- Absolute neutrophil count of at least 1000/mcL within 14 days prior to registration
- Platelet count of at least 75,000/mcL within 14 days prior to registration
- Total bilirubin less than or equal to 1.5 times the upper limit of normal within 14 days prior to registration; if higher, direct bilirubin must be normal
- ALT and AST levels less than or equal to 2.5 times the upper limit of normal (up to 5 times if liver involvement) within 14 days prior to registration
- Creatinine clearance of at least 45 ml/min within 14 days prior to registration
- Two negative pregnancy tests before starting study treatment
- Ability and willingness to return for follow-up visits
- Agreement not to donate blood during treatment and for at least 28 days after last golcadomide dose
You will not qualify if you...
- Pregnant or nursing individuals
- Persons of childbearing potential or able to father a child who do not use adequate contraception or abstain as required during and after treatment
- Life expectancy less than 3 months
- Prior CAR-T or T-cell targeting treatment within 4 weeks before registration
- Recent systemic anti-cancer treatments within 5 half-lives or 4 weeks before registration, except certain antibodies
- Prior therapy with golcadomide within 4 weeks before registration
- Recent autologous stem cell transplant within 3 months or unresolved toxicity from previous transplant
- Major surgery within 3 weeks before registration
- Chemotherapy within 2 weeks before registration
- Concurrent radiation therapy except local palliative radiotherapy
- Severe co-morbid illnesses or other cancers interfering with safety or assessment
- Significant heart conditions including symptomatic heart failure or recent myocardial infarction
- Uncontrolled infections or psychiatric illness affecting participation
- Prior allogeneic stem cell transplant within 6 months or unresolved toxicity
- Immunocompromised patients including HIV positive with antiretroviral therapy
- Active chronic hepatitis B or C infection unless viral load is undetectable with suppressive therapy
- Use of strong or moderate CYP3A4/5 inhibitors or inducers within 14 days before treatment
- Receiving other investigational agents for lymphoma except corticosteroids
- Active second cancer requiring treatment interfering with study assessments
- History of deep vein thrombosis, pulmonary embolism, or thrombophilia unless willing to use full anticoagulation during treatment
- Live COVID-19 vaccine administered within 28 days before registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 28 days each
Participants receive golcadomide orally once daily on days 1-14 and rituximab intravenously on specified days during each 28-day cycle. Treatment consists of up to 2 cycles initially, followed by further cycles depending on eligibility for CAR-T therapy.
Multiple visits each cycle to receive rituximab and golcadomide dosing
Duration - Up to 2 additional 28-day cycles before CAR-T therapy
After 2 cycles, participants eligible for CAR-T undergo leukapheresis and may receive 1 to 2 additional cycles of golcadomide and rituximab prior to undergoing CAR-T therapy.
Visits for leukapheresis and treatment administration
Duration - Duration of CAR-T therapy as per standard care
Participants eligible for CAR-T receive standard of care chimeric antigen receptor T-cell therapy following bridging treatment.
Visits as per CAR-T therapy schedule
Duration - Up to 2 years
After CAR-T therapy, participants are followed up at 180 days and then every 6 months for up to 2 years to monitor health status and disease progression.
Visits every 6 months after initial 180-day follow-up
Duration - Up to 10 additional 28-day cycles and up to 2 years follow-up
Participants not eligible for CAR-T continue receiving golcadomide and rituximab for up to 10 additional cycles. After treatment, participants are followed up every 3 months until progression or subsequent treatment, then every 6 months for up to 2 years.
Multiple treatment visits and follow-up visits every 3 months then every 6 months
Trial Site Locations
Total: 7 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
3
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
Actively Recruiting
4
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States, 56001
Actively Recruiting
5
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, United States, 54701
Actively Recruiting
7
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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