Golcadomide and Rituximab for Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy
This study is testing a combination of two medications, golcadomide and rituximab, as a "bridging therapy" for people with aggressive B-cell non-Hodgkin lymphoma that has returned or not responded to previous treatments. Bridging therapy helps manage your condition until you can receive CAR T-cell therapy, which is a type of immunotherapy that uses your own modified immune cells to fight cancer. The study is looking to see how well golcadomide and rituximab control the cancer before CAR T-cell therapy. You may be eligible if you are 18 or older and have certain types of relapsed or refractory diffuse large B-cell lymphoma, among other conditions. The study aims to enroll 41 participants.
- Study design
- This is an interventional study with a planned enrollment of 41 participants. It is testing the effectiveness of golcadomide and rituximab as a bridging therapy.
- What's involved
- You would undergo blood sample collection, bone marrow aspiration and biopsy, and CT or PET/CT scans. You would also receive golcadomide orally once daily and rituximab intravenously during treatment cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is to evaluate disease control after 2 cycles of therapy (each cycle is 28 days).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06834373
Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy
Recruiting
PHASE2Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~41 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow AspirationBone Marrow BiopsyChimeric Antigen Receptor T-Cell TherapyComputed TomographyGolcadomide
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease control
Measured over 2 cycles (cycle length = 28 days)
Conditions
NCT06834373
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesotastudy coordinator listed
Recruiting
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsinstudy coordinator listed
Recruiting
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsinstudy coordinator listed
Recruiting
Mayo Clinic Health Systems-Mankato
Mankato, Minnesotastudy coordinator listed
Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizonastudy coordinator listed
Recruiting
Mayo Clinic in Florida
Jacksonville, Floridastudy coordinator listed
Recruiting
Mayo Clinic in Rochester
Rochester, Minnesotastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Claire Tiger, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Eligibility criteria
Inclusion
Age ≥ 18 years
Confirmed pathology diagnosis according to 2016 World Health Organization (WHO) classification including patients with diseases listed below with relapsed, progressive and/or refractory disease (Cheson et al. 2014) following treatment with one or two prior lines of standard therapy, no more than two lines of therapy are permitted:
Diffuse large B-cell lymphoma not otherwise specified (NOS) including:
Transformed lymphoma
Germinal center B-cell type
Activated B-cell type
High-grade B-cell lymphoma (HGBCL), NOS
High grade B-cell lymphoma with MYC and BCL2 translocation
Primary mediastinal (thymic) large B-cell lymphoma
Grade 3B follicular lymphoma
T-cell/histiocyte-rich large B-cell lymphoma
Large B-cell lymphoma with IRF4 rearrangement
Primary cutaneous diffuse large B-cell lymphoma (DLBCL), leg type
Epstein-Barr virus (EBV) positive DLBCL, NOS
DLBCL associated with chronic inflammation
Intravascular large B-cell lymphoma
ALK positive large B-cell lymphoma
NOTE: Richters transformation patients are excluded
Measurable disease by PET-CT with at least one lymph node or other type of lesion that has a size \> 1.5 cm in the transverse diameter, as defined by Lugano classification
NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible
Patient is potentially eligible for CAR-T therapy as determined by treating physician
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Hemoglobin \> 7.0 g/dL (obtained ≤ 14 days prior to registration)
Absolute neutrophil count (ANC) ≥ 1000/mcL (obtained ≤ 14 days prior to registration); growth factor support allowed at physician discretion
Platelet count ≥ 75,000/mcL (obtained ≤ 14 days prior to registration)
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration); if total bilirubin is \> 1.5 ULN, direct bilirubin must be normal
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN (≤ 5 x ULN if there is evidence of parenchymal liver involvement with lymphoma) (obtained ≤ 14 days prior to registration)
Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)
Have 2 negative pregnancy tests as verified by the investigator prior to starting CC-99282:
A negative serum pregnancy test (sensitivity of at least 25 mIU/mL) at screening (between 10 to 14 days prior to cycle 1 day 1)
A negative serum or urine pregnancy test (investigator's discretion) within 24 hours prior to cycle 1 day 1 of study treatment
Provide written informed consent
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Subjects must agree not to donate blood while receiving golcadomide, during dose interruptions and for ≥ 28 days following the last dose of golcadomide
Exclusion
Any of the following because this study involves an investigational agent that has known genotoxic, mutagenic, and teratogenic effects:
Pregnant persons
Nursing persons
Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
Persons of childbearing potential (PCBP) unwilling to use two reliable forms of contraception simultaneously or to practice complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \[e.g., calendar, ovulation, symptothermal or postovulation methods\] and withdrawal are not acceptable methods of contraception) from heterosexual contact during the following time periods related to this study:
For ≥ 28 days before starting treatment, during treatment and dose interruptions, and for ≥ 28 days after the last dose of golcadomide
Examples of highly effective methods of contraception:
Intrauterine device (IUD)
Hormonal (birth control pills, injections, implants, levonorgestrel-releasing intrauterine system \[IUS\], medroxyprogesterone acetate depot injections, ovulation inhibitory
Progesterone-only pills \[e.g., desogestrel\])
Tubal ligation
Partner's vasectomy
Examples of additional effective methods:
Male condom
Diaphragm
Cervical cap
Persons who can father a child unwilling to practice complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \[e.g., calendar, ovulation, symptothermal or post-ovulation methods\] and withdrawal are not acceptable methods of contraception.) or unwilling to use a condom during sexual contact with a pregnant person or a PCBP during treatment and dose interruptions, and for \> 28 days following the last dose of golcadomide, even if they have undergone a successful vasectomy
Persons who can father a child and are unwilling to refrain from donating semen or sperm while receiving golcadomide, during dose interruptions, or for ≥ 28 days following the last dose of golcadomide
Life expectancy \< 3 months
Any of the following prior therapies:
Any prior CAR-T or other T-cell targeting treatment (approved or investigational) ≤ 4 weeks prior to registration
Any prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to registration, whichever is shorter
Exception: Monoclonal and bispecific antibodies is acceptable
Prior therapy with golcadomide ≤ 4 weeks prior to registration
Prior autologous stem cell transplantation (SCT) ≤ 3 months prior to registration. If subject had autologous SCT \> 3 months prior to the start of registration, any treatment-related toxicity is unresolved (grade \> 1)
Major surgery ≤ 3 weeks prior to registration
Chemotherapy ≤ 2 weeks prior to registration
Concomitant radiation therapy; local palliative radiotherapy is permitted
Co-morbid systemic illnesses or other severe concurrent disease or cancer which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Impaired cardiac function or clinically significant cardiac diseases including, but not limited to:
Symptomatic congestive heart failure
History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Unstable angina pectoris
Cardiac arrhythmia
Uncontrolled intercurrent non-cardiac illness including, but not limited to:
Ongoing or active infection
Psychiatric illness/social situations
Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy (such as interstitial lung disease or chronic obstructive pulmonary disease \[COPD\])
Any other conditions that would limit compliance with study requirements
Subject had prior allogeneic SCT with either standard or reduced intensity conditioning ≤ 6 months prior to registration. If subject had prior allogeneic SCT \> 6 months prior to registration, any treatment-related toxicity is unresolved (grade \>1)
Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy, as there is currently no safety data in HIV positive patients
Subject has known chronic active hepatitis B or C virus (HBV/HCV) infection
Exception: Patients with HBV and an undetectable viral load who are on suppressive therapy and/or those with HCV and an undetectable viral load are allowed
Concurrent administration of strong or moderate CYP3A4/5 inhibitors and inducers within 14 days or 5 half-lives, whichever is longer before the study treatment administration
Receiving any other investigational agent which would be considered as a treatment for lymphoma.
Exception: Corticosteroids are allowed
Active second malignancy requiring treatment that would interfere with the assessment of the response of the primary cancer or interpretation of the safety of this protocol therapy
History of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia. Patients with a history of deep vein thrombosis (DVT)/pulmonary embolism (PE) or thrombophilia may still participate if they are willing to be on full anticoagulation during treatment. Full anticoagulation is defined as Warfarin, factor X inhibitors, or low molecular weight heparin at therapeutic doses. The rationale for this requirement is that golcadomide therapy is associated with an increased risk of thrombosis. Patients with no history of DVT/PE or thrombophilia are not required to take anticoagulation and/or anti-platelet prophylaxis
NOTE: If a patient develops a thrombotic event, they must be able and willing to receive anticoagulation therapy with aspirin 81-325 mg daily prophylaxis, low molecular weight heparin, factor X inhibitors or Warfarin. This is due to an increased risk of thrombosis in patients treated with golcadomide without prophylaxis
Live COVID-19 vaccine administered ≤ 28 days prior to registration
What this trial measures
- Disease control2 cycles (cycle length = 28 days)
Will be defined as a complete metabolic response (CMR), partial metabolic response (PMR), or no metabolic response (NMR) by Lugano 2014 PET-CT.