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Brentuximab Vedotin in Treating Patients With Relapsed or Refractory CD30+ Lymphoma

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
Phase       Pilot

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Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

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)

- 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

Other exclusion criteria may apply.

Research Study Number       7808
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

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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Please remember:

  • 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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