Comparing Gemcitabine with Brentuximab vedotin for Hodgkin lymphoma

Exclusion

• −Known history of human immunodeficiency virus (HIV), active Hepatitis C Virus infection, active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics. Participants that are Hepatitis B core antibody positive are eligible if they are HBV DNA negative and are concurrently treated with anti-viral therapy. Participants with a past history of hepatitis C who have eradicated the virus are eligible
• −Participants who have received prior salvage systemic therapy for their relapsed or refractory disease.
• −History of peripheral neuropathy or dyspnea ≥ grade 2
• −Participants with a history of other malignancies except: adequately treated non-melanoma skin cancer and superficial bladder cancer, curatively treated in-situ cancer of the cervix or breast, or localized excised prostate cancer, other solid tumours curatively treated with no evidence of disease for \> 3 years
• −History of active CNS disease
• −Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at doses more than 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first and any dose of trial treatment
• −Has active autoimmune disease that has required systemic treatment in the past 3 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or history of allogeneic transplantation. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• −Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, angina, or myocardial infarction within 6 months of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
• −Documented history of cerebral vascular event (stroke or transient ischemic attack)
• −History of progressive multifocal leukoencephalopathy (PML).
• −Any serious active disease or co-morbid medical condition, including psychiatric illness, judged by the local investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → to preclude safe administration of the planned protocolProtocolThe detailed plan a study must follow.Read more → treatment or required follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →
• −Any other serious intercurrent illness, life-threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example): active, uncontrolled bacterial, fungal or viral infection; clinically significant cardiac dysfunction or cardiovascular disease
• −Participants who have been vaccinated with live, attenuated vaccines within 4 weeks of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
• −Participants are not eligible if they have had a prior infusion reaction to the study drugs or their components \> grade 2
• −Participant has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
• −Participant has had an allogenic tissue/solid organ transplant
• −Concurrent or within the previous 4 weeks of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, treatment with other investigational drugs or anti-cancer therapy
• −Pregnant or lactating females, or women/men of childbearing potential not willing to use an adequate method of birth controlControl groupThe group a new treatment is measured against.Read more → for the duration of the study through 6 months after the last dose of trial treatment
• −Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A one-week washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → is permitted for palliative radiation (≤ 2 weeks of radiotherapy)