NCT06834373 · Mayo Clinic
Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy
What this study 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).
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Bone Marrow Aspiration
Undergo bone marrow aspiration and biopsy
PROCEDURE
Bone Marrow Biopsy
Undergo bone marrow aspiration and biopsy
BIOLOGICAL
Chimeric Antigen Receptor T-Cell Therapy
Undergo standard of care CAR-T therapy
PROCEDURE
Computed Tomography
Undergo CT or PET/CT
DRUG
Golcadomide
Given PO
PROCEDURE
Leukapheresis
Undergo leukapheresis
PROCEDURE
Positron Emission Tomography
Undergo PET/CT
BIOLOGICAL
Rituximab
Given IV
Primary outcome measures
Disease control
Time frame: 2 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Scottsdale, Arizona
- Jacksonville, Florida
- Albert Lea, Minnesota
- Mankato, Minnesota
- Rochester, Minnesota
- Eau Claire, Wisconsin
- La Crosse, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 28, 2026 · Source of record for eligibility and locations