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Complete title: A Pilot Study of Weekly Brentuximab Vedotin in Patients with CD30+ Malignancies Refractory to Every >3 Week Brentuximab Vedotin
|Research Study Number||7808|
|Principal Investigator||Ajay Gopal, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Relapsed or refractory CD30+ lymphoma that has either achieved < PR to brentuximab vedotin (minimum of 2 cycles) or progressed while receiving brentuximab vedotin
- Documented expression of CD30 on tumor cells following the last dose of brentuximab vedotin
- Absolute neutrophil count (ANC) > 1,000/uL
- Platelets > 50,000/uL
- Serum creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min
- Bilirubin < 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
- Measurable disease by computed tomography (CT) or similar (e.g. magnetic resonance imaging [MRI]) criteria (> 1.5 cm)
- Resolution of all non-hematologic brentuximab vedotin-related adverse events (AEs) to < Grade 2
- All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
- Patients must be anticipated to complete at least 2 cycles of chemotherapy on study
- Expected survival if untreated of > 90 days
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Radioimmunotherapy within 12 weeks
- Known human immunodeficiency virus (HIV) or hepatitis B positivity
- Active infection or other medical condition which would preclude treatment in the opinion of the principal investigator
- Eastern Cooperative Oncology Group (ECOG) performance status > 2
- Known active central nervous system (CNS) involvement
- Peripheral neuropathy > Grade 1 if due to brentuximab vedotin or any peripheral neuropathy > Grade 2
- Intolerance to brentuximab vedotin
- Concurrent use of other anti-cancer agents or experimental treatments
Other exclusion criteria may apply.
Lymphoma, Burkitt's; Hematologic Malignancies; Leukemia; Lymphoma; Lymphoproliferative Disorders; Lymphoma, Non-Hodgkin (NHL); Waldenstrom Macroglobulinemia; Lymphoma, Mantle-Cell; Lymphoma, B-Cell; Lymphoma, T-Cell; Lymphoma, Large-Cell, Anaplastic; Lymp
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