Actively Recruiting
Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy
Led by Mayo Clinic · Updated on 2026-01-28
41
Participants Needed
7
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests the effectiveness of golcadomide and rituximab as bridging treatment before chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Patients that are able to receive CAR T-cell therapy have a potential for cure, however, many will not be qualified to receive therapy due to relapse. Bridging therapy is therapy intended to transition a patient from one therapy or medication to another or maintain their health or status until they are a candidate for a therapy or have decided on a therapy. Golcadomide may help block the formation, growth or spread of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving golcadomide and rituximab as bridging therapy before CAR T-cell therapy may kill more tumor cells and may improve the chance of proceeding to CAR T-cell therapy in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
CONDITIONS
Official 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 types listed, including diffuse large B-cell lymphoma subtypes, high-grade B-cell lymphoma, and related forms
- Measurable disease by PET-CT with at least one lesion larger than 1.5 cm
- Potential eligibility for CAR T-cell therapy as determined by treating physician
- Eastern Cooperative Oncology Group performance status 0, 1, or 2
- Hemoglobin greater than 7.0 g/dL within 14 days prior to registration
- Absolute neutrophil count at least 1000/mcL within 14 days prior to registration
- Platelet count at least 75,000/mcL within 14 days prior to registration
- Total bilirubin no more than 1.5 times upper normal limit; if higher, direct bilirubin must be normal
- ALT and AST levels not exceeding 2.5 times upper normal limit, or up to 5 times if liver involved
- Creatinine clearance at least 45 ml/min within 14 days prior to registration
- Two negative pregnancy tests before starting study treatment
- Ability and willingness to provide informed consent and return for follow-up visits
- Agreement not to donate blood during treatment and for 28 days after last dose of golcadomide
You will not qualify if you...
- Pregnant or nursing individuals
- Persons of childbearing potential or able to father a child unwilling to use effective contraception or abstain during specified study periods
- Life expectancy less than 3 months
- Prior CAR T-cell or T-cell targeting treatments within 4 weeks before registration
- Prior systemic anti-cancer treatment within 5 half-lives or 4 weeks before registration, except monoclonal and bispecific antibodies
- Previous treatment with golcadomide within 4 weeks before registration
- Autologous stem cell transplant within 3 months before registration with unresolved toxicity
- Major surgery within 3 weeks before registration
- Chemotherapy within 2 weeks before registration
- Concomitant radiation therapy except palliative local radiotherapy
- Severe co-existing diseases or illnesses interfering with study participation
- Significant cardiac diseases such as symptomatic heart failure, recent myocardial infarction, unstable angina, or arrhythmias
- Uncontrolled infections, psychiatric illness, or conditions limiting study compliance
- Allogeneic stem cell transplant within 6 months before registration with unresolved toxicity
- Immunocompromised patients or HIV positive on antiretroviral therapy
- Active chronic hepatitis B or C infections unless viral load undetectable and suppressed
- Recent use of strong or moderate CYP3A4/5 inhibitors or inducers before treatment
- Use of other investigational agents for lymphoma, except corticosteroids
- Active second malignancy requiring interfering treatment
- History of deep vein thrombosis, embolism, or thrombophilia unless willing to take full anticoagulation during treatment
- Receipt of live COVID-19 vaccine within 28 days prior to registration
AI-Screening
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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
CONTACT
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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