A phase 2 open-label study of brentuximab vedotin in front-line therapy of Hodgkin lymphoma (HL) and CD30-expressing peripheral T-cell lymphoma (PTCL) in older patients or patients with significant comorbidities ineligible for standard chemotherapy -

SEATTLE GENETICS, INC.0 个研究点目标入组 100 人开始时间: 2020年11月6日最近更新: 2020年12月7日

适应症

试验速览

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•Study parts E and F:
•1. Treatment-naive patients with histopathological diagnosis of classical HL (Part E), or treatment-naive patients with CD30-expressing (> or = 1%) PTCL (Part F).
•2. age > or = 18 years
•3. Patients must be unsuitable or unfit for initial conventional combination chemotherapy for HL or CD30-expressing PTCL due to the presence of comorbidity-related factors, as documented by:
•a. a CIRS score > or = 10 OR
•b. requiring assistance with or dependence on others for any IADLs.
•4. Patients must have fluorodeoxyglucose (FDG)-PET-avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique.
•5. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of < or = 3
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1. Baseline peripheral neuropathy Grade > or = 2 or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
•2. History of progressive multifocal leukoencephalopathy (PML)
•3. Any active Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin. Routine antimicrobial prophylaxis is permitted.
•7. Kidney disease requiring ongoing dialysis
•15. Known cerebral/meningeal disease related to the underlying malignancy.
•17. Known to be positive for hepatitis B by surface antigen expression. Known to be positive for hepatitis C infection (positive by polymerase chain reaction [PCR]). Patients who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of 12 weeks
•18. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
•19. Active hepatitis C infection (positive by serology and confirmed by PCR or on antiviral therapy for hepatitis C within the last 6 months).
•21. History of another malignancy within 1 year before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.

发起方

SEATTLE GENETICS, INC.