SCCA Lymphoma Clinical Trials
Brentuximab Vedotin for Relapsed or Refractory CD30+ Lymphoma (FH 7808)
A Pilot Study of Weekly Brentuximab Vedotin in Patients With CD30+ Malignancies Refractory to Every >= 3 Week Brentuximab Vedotin
| Status | Conditions | Phase | Study ID |
| Recruiting | Lymphoma | N/A |
FH 7808 NCT01703949 |
Summary
This pilot clinical trial studies brentuximab vedotin in treating patients with relapsed or refractory cluster of differentiation (CD)30+ lymphoma. Biological therapies, such as brentuximab vedotin, may stimulate the immune system in different ways and stop cancer cells from growing
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Eligibility Criteria (must meet the following to participate in this study)
- 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
Exclusions (conditions that would prevent participation in this study)
- Prior transplant within 100 days
- 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
Last Updated
November 08, 2012See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.
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