OncoMatch/Clinical Trials/NCT06834373
Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy
Is NCT06834373 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Chimeric Antigen Receptor T-Cell Therapy and Rituximab for large b-cell lymphoma with irf4 rearrangement.
Treatment: Chimeric Antigen Receptor T-Cell Therapy · Golcadomide · Rituximab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: MYC rearrangement
High grade B-cell lymphoma with MYC and BCL2 translocation
Allowed: BCL2 rearrangement
High grade B-cell lymphoma with MYC and BCL2 translocation
Allowed: IRF4 rearrangement
Large B-cell lymphoma with IRF4 rearrangement
Allowed: ALK fusion
ALK positive large B-cell lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic anti-cancer treatment
relapsed, progressive and/or refractory disease (Cheson et al. 2014) following treatment with one or two prior lines of standard therapy
Cannot have received: CAR-T cell therapy
Exception: allowed if > 4 weeks prior to registration
Any prior CAR-T or other T-cell targeting treatment (approved or investigational) ≤ 4 weeks prior to registration
Cannot have received: systemic anti-cancer treatment
Exception: allowed if > 5 half-lives or 4 weeks prior to registration, whichever is shorter; monoclonal and bispecific antibodies is acceptable
Any prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to registration, whichever is shorter
Cannot have received: golcadomide (golcadomide)
Exception: allowed if > 4 weeks prior to registration
Prior therapy with golcadomide ≤ 4 weeks prior to registration
Cannot have received: autologous stem cell transplantation
Exception: allowed if > 3 months prior to registration and all treatment-related toxicity resolved (grade ≤ 1)
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)
Cannot have received: major surgery
Exception: allowed if > 3 weeks prior to registration
Major surgery ≤ 3 weeks prior to registration
Cannot have received: chemotherapy
Exception: allowed if > 2 weeks prior to registration
Chemotherapy ≤ 2 weeks prior to registration
Cannot have received: allogeneic stem cell transplantation
Exception: allowed if > 6 months prior to registration and all treatment-related toxicity resolved (grade ≤ 1)
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)
Lab requirements
Blood counts
Hemoglobin > 7.0 g/dL; ANC ≥ 1000/mcL; Platelet count ≥ 75,000/mcL
Kidney function
Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x ULN (if > 1.5 ULN, direct bilirubin must be normal); ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN if there is evidence of parenchymal liver involvement with lymphoma)
Cardiac function
No symptomatic congestive heart failure, history of myocardial infarction ≤ 6 months, unstable angina pectoris, cardiac arrhythmia, or congestive heart failure requiring ongoing maintenance therapy for life-threatening ventricular arrhythmias
Hemoglobin > 7.0 g/dL; ANC ≥ 1000/mcL; Platelet count ≥ 75,000/mcL; Total bilirubin ≤ 1.5 x ULN (if > 1.5 ULN, direct bilirubin must be normal); ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN if there is evidence of parenchymal liver involvement with lymphoma); Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula; Impaired cardiac function or clinically significant cardiac diseases including, but not limited to: Symptomatic congestive heart failure, history of myocardial infarction ≤ 6 months, unstable angina pectoris, cardiac arrhythmia, or congestive heart failure requiring ongoing maintenance therapy for life-threatening ventricular arrhythmias
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Arizona · Scottsdale, Arizona
- Mayo Clinic in Florida · Jacksonville, Florida
- Mayo Clinic Health System in Albert Lea · Albert Lea, Minnesota
- Mayo Clinic Health Systems-Mankato · Mankato, Minnesota
- Mayo Clinic in Rochester · Rochester, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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