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Compares treatment options for Nodular Lymphocyte Predominant B-Cell Lymphoma
Official title Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial
ClinicalTrials.gov ID: NCT05886036
What this study is testing
What is Mosunetuzumab?
Mosunetuzumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for nodular lymphocyte predominant b-cell lymphoma.
Also referred to as Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody BTCT4465A, BTCT 4465A.
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 compares mosunetuzumab to the usual treatment (rituximab) for improving survival in patients with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). Rituximab and mosunetuzumab are monoclonal antibodies.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Histopathologically confirmed diagnosis of NLPHL as confirmed by local pathologist's expert review.
- Untreated NLPHL: stage IB to IV according to Cotswolds. The proportion of patients with stages I or II treated with consolidative radiotherapy will...
- Previously treated NLPHL, any stage.
- According to the treating physician, the patient should not be observed and needs therapy, notably because of B-symptoms (unexplained fever...
- Patients must have measurable disease according to the Lugano/Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) classification.
You likely can't join if
- Classical Hodgkin lymphoma (cHL) or composite lymphoma.
- Transformed NLPHL, concerns of the treating physician of an occult transformation or concerns of the treating physician that the patient needs...
- NLPHL relapse less than 6 months after rituximab or rituximab-containing therapy.
- Patients who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia.
- Patients who are receiving any other investigational agents.
- Patients with central nervous system (CNS) involvement as a result of lymphoma.
See the full eligibility criteria
Who can join
- Histopathologically confirmed diagnosis of NLPHL as confirmed by local pathologist's expert review.
- Untreated NLPHL: stage IB to IV according to Cotswolds. The proportion of patients with stages I or II treated with consolidative radiotherapy will be capped at 40%.
- Previously treated NLPHL, any stage.
- According to the treating physician, the patient should not be observed and needs therapy, notably because of B-symptoms (unexplained fever [temperature \> 38 degrees Celsius (\> 100.4 degrees Fahrenheit)], weight loss...
- Patients must have measurable disease according to the Lugano/Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) classification.
- Age \>= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of mosunetuzumab in patients \< 18 years of age, children are excluded from this study.
- Eastern Cooperative Oncology Group performance status =\ = 60%).
- Absolute neutrophil count \>= 1,000/mcL.
- Platelets \>= 100,000/mcL.
- Total bilirubin =\ 80% unconjugated bilirubin.
- Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine transaminase (ALT)(serum glutamic-pyruvic transaminase [SGPT]) =\< 3 x institutional ULN.
- Glomerular filtration rate (GFR) \>= 40mL /min= GFR (mL/Min/1.73 m\^2) \ body surface area (BSA)/1.73.
- Human immunodeficiency virus-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- The effects of mosunetuzumab on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must...
- Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
What rules you out
- Classical Hodgkin lymphoma (cHL) or composite lymphoma.
- Transformed NLPHL, concerns of the treating physician of an occult transformation or concerns of the treating physician that the patient needs cytotoxic therapy.
- NLPHL relapse less than 6 months after rituximab or rituximab-containing therapy.
- Patients who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia.
- Patients who are receiving any other investigational agents.
- Patients with central nervous system (CNS) involvement as a result of lymphoma.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to mosunetuzumab or rituximab.
- Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.
- Pregnant women are excluded from this study because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with mosunetuzumab; breastfeeding should be discontinued if the...
- Prior allogeneic stem cell or solid organ transplantation.
- Participants who have received a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live, attenuated vaccine will be required during the study. Participants must not...
- Any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment.
- Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results as judged by the investigator, including, but not limited to:
- Significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina).
- Significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm).
- Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
- Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed.
- Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible only for the expansion cohort.
- History of confirmed progressive multifocal leukoencephalopathy (PML).
- Participants with infections requiring IV treatment with antibiotics or hospitalization (grade 3 or 4) within the last 4 weeks prior to enrollment or known active bacterial, viral (including SARS-CoV-2), fungal...
- Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to first dose of study...
- Known or suspected chronic active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection.
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Aventura, Florida, United States
- Coral Gables, Florida, United States
- Coral Springs, Florida, United States
- Deerfield Beach, Florida, United States
- Doral, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Atlanta, Georgia, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
- Westwood, Kansas, United States
- Kansas City, Missouri, United States
- Lee's Summit, Missouri, United States
- North Kansas City, Missouri, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
+ 14 more site(s).
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Duarte, California, United States; Aventura, Florida, United States; Coral Gables, Florida, United States; Coral Springs, Florida, United States; Deerfield Beach, Florida, United States; Doral, Florida, United States and 28 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.