Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy

Recruiting now · Phase 2

Conditions studied: Large B-Cell Lymphoma With IRF4 Rearrangement, Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma, Recurrent ALK-Positive Large B-Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type, Recurrent Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation, Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent Grade 3b Follicular Lymphoma, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements, Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified, Recurrent Intravascular Large B-Cell Lymphoma, Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type, Recurrent Primary Mediastinal Large B-Cell Lymphoma, Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma, Recurrent Transformed Non-Hodgkin Lymphoma, Refractory Aggressive B-Cell Non-Hodgkin Lymphoma, Refractory ALK-Positive Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type, Refractory Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation, Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Refractory EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Refractory Grade 3b Follicular Lymphoma, Refractory High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements, Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified, Refractory Intravascular Large B-Cell Lymphoma, Refractory Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type, Refractory Primary Mediastinal Large B-Cell Lymphoma, Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma, Refractory Transformed Non-Hodgkin Lymphoma

In brief

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.

Key facts

Study ID

NCT06834373

Run by

Mayo Clinic

People needed

41

Starts

2025-04-02

Expected to finish

2027-03-03

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
• Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States (enrolling)
• Mayo Clinic Health Systems-Mankato — Mankato, Minnesota, United States (enrolling)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
• Mayo Clinic Health System-Eau Claire Clinic — Eau Claire, Wisconsin, United States (enrolling)
• Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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