BridgeMD
New treatment option for Large B-Cell Lymphoma With IRF4 Rearrangement
Official title Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy
ClinicalTrials.gov ID: NCT06834373
What this study is testing
What is Chimeric Antigen Receptor T-Cell Therapy?
Chimeric Antigen Receptor T-Cell Therapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for large b-cell lymphoma with irf4 rearrangement.
Also referred to as CAR T Infusion, CAR T Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Confirmed pathology diagnosis according to 2016 World Health Organization (WHO) classification including patients with diseases listed below with...
- Diffuse large B-cell lymphoma not otherwise specified (NOS) including:
- Transformed lymphoma
- Germinal center B-cell type
You likely can't join 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...
- For ≥ 28 days before starting treatment, during treatment and dose interruptions, and for ≥ 28 days after the last dose of golcadomide
See the full eligibility criteria
Who can join
- 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)...
- 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)
- people must agree not to donate blood while receiving golcadomide, during dose interruptions and for ≥ 28 days following the last dose of golcadomide
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Live COVID-19 vaccine administered ≤ 28 days prior to registration
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Albert Lea, Minnesota, United States
- Mankato, Minnesota, United States
- Rochester, Minnesota, United States
- Eau Claire, Wisconsin, United States
- La Crosse, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Albert Lea, Minnesota, United States; Mankato, Minnesota, United States; Rochester, Minnesota, United States; Eau Claire, Wisconsin, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.