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New treatment option for Ann Arbor Stage I Primary Mediastinal (Thymic) Large B-Cell Lymphoma
Official title PACIFIC: Primary Mediastinal Large B-cell Lymphoma Treated With Antibody Therapy, Checkpoint Inhibitor in Frontline With ImmunoChemotherapy
ClinicalTrials.gov ID: NCT04745949
What this study is testing
What is Brentuximab Vedotin?
Brentuximab Vedotin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ann arbor stage i primary mediastinal (thymic) large b-cell lymphoma.
Also referred to as ADC SGN-35, Adcetris.
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 studies the effect of brentuximab vedotin and nivolumab alone and in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone in treating patients with untreated, stage I-IV primary mediastinal large B-cell lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a toxic agent, called vedotin.
- Phase 2: a mid-size study of how well it works
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 PMBL
- Require a CD30 expression level of 1% or greater in the tumor or tumor-infiltrating lymphocytes by local immunohistochemistry
- No prior treatment except
- A prior limited-field radiotherapy
- A short course (up to 7 days) of glucocorticoids =\< 100 mg daily of prednisone equivalent which must cease prior to day 1 of cycle 1
You likely can't join if
- Patients with an urgent need for cytoreductive treatment will be excluded
- Any serious medical condition including but not limited to uncontrolled hypertension, uncontrolled congestive heart failure within past 6 months...
- Previous anthracycline exposure with expected lifetime exposure to doxorubicin \> 450 mg/m\^2, considering the planned anthracycline exposure in this...
- Pregnant or lactating females
- Known hypersensitivity to brentuximab vedotin, nivolumab, rituximab, doxorubicin, cyclophosphamide, or prednisone
- Known human immunodeficiency virus (HIV) infection with active viremia
See the full eligibility criteria
- Histopathologically confirmed diagnosis of PMBL
- Require a CD30 expression level of 1% or greater in the tumor or tumor-infiltrating lymphocytes by local immunohistochemistry
- No prior treatment except
- A prior limited-field radiotherapy
- A short course (up to 7 days) of glucocorticoids =\< 100 mg daily of prednisone equivalent which must cease prior to day 1 of cycle 1
- Stage of patients: Stages II, III, IV, and stage I \>= 5 cm in the greatest dimension
- Patient or durable power of attorney (DPA) for healthcare must be able to understand and voluntarily sign an Institutional Review Board (IRB)-approved informed consent form
- Age \>= 18 years at the time of signing the informed consent
- Patients must have bi-dimensional measurable disease, as defined as radiographically apparent disease with the longest dimension of \>= 1.5 cm
- Patients with performance status of =\< 3 (3 only allowed if decline in status is deemed related to lymphoma and felt potentially reversible by the treating physician)
- Serum bilirubin \ 80% unconjugated bilirubin
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 3 x ULN or \< 5 x ULN if hepatic metastases are...
- Absolute neutrophil count (ANC) \> 1000/mm\^3 unless deemed related to lymphoma involvement in the bone marrow and felt potentially reversible by the treating physician
- Platelets \> 1000/mm\^3 unless deemed related to lymphoma involvement in the bone marrow and felt potentially reversible by the treating physician
- Calculated creatinine clearance \>= 30 ml/min by Cockcroft-Gault formula
- Patients must be willing to receive transfusions of blood products
- Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at screening
- Women of childbearing potential and men who are sexually active with a woman of childbearing potential must be practicing a highly effective method of birth control during and after the study (12 months for women and 3...
- Patients with an urgent need for cytoreductive treatment will be excluded
- Any serious medical condition including but not limited to uncontrolled hypertension, uncontrolled congestive heart failure within past 6 months prior to screening (class 3 [moderate] or class 4 [severe] cardiac disease...
- Previous anthracycline exposure with expected lifetime exposure to doxorubicin \> 450 mg/m\^2, considering the planned anthracycline exposure in this study with potential six cycles of R-CHP
- Pregnant or lactating females
- Known hypersensitivity to brentuximab vedotin, nivolumab, rituximab, doxorubicin, cyclophosphamide, or prednisone
- Known human immunodeficiency virus (HIV) infection with active viremia
- Patient with known HIV infection can be included if undetectable viral load, CD4 \>= 300 cells/microL and on HAART (highly active antiretroviral therapy)
- Patients with active viremia of hepatitis B infection
- Not including patients with prior hepatitis B vaccination; or positive serum hepatitis B antibody
- Patients with active viremia of hepatitis C infection
- Known hepatitis C infection is allowed as long as there is no active disease and is cleared by gastrointestinal (GI) consultation
- All patients with central nervous system involvement with lymphoma
- Diagnosis of prior malignancy within the past 2 years with the exception of successfully treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma "in situ" of the cervix or breast. History of other...
- Significant neuropathy (grades 2 or grade 1 with pain) within 14 days prior to enrollment
- Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment including pleural effusion requiring thoracentesis or...
- Major surgery within 4 weeks of study entry or wound that is not healed from prior surgery or trauma
- History of stroke or intracranial hemorrhage within 6 months prior to study entry
- Vaccinated with live, attenuated vaccines within 4 weeks of study entry
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 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 Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.