Brentuximab Vedotin in Treating Patients With Relapsed or Refractory CD30+ Lymphoma
|CD30-Positive Neoplastic Cells Present Recurrent Hodgkin Lymphoma Recurrent Non-Hodgkin Lymphoma Refractory Hodgkin Lymphoma Refractory Non-Hodgkin Lymphoma||Drug: Brentuximab Vedotin Other: Laboratory Biomarker Analysis|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Weekly Brentuximab Vedotin in Patients With CD30+ Malignancies Refractory to Every ≥ 3 Week Brentuximab Vedotin|
- Overall response rate as measured by the Cheson 2007 criteria [ Time Frame: Up to 5 weeks after completion of study treatment ]No formal statistical measures will be pre-specified. This protocol will be deemed a "success" if the absolute response rate in this group of patients is >= 20%.
|Study Start Date:||March 20, 2013|
|Estimated Primary Completion Date:||January 15, 2021 (Final data collection date for primary outcome measure)|
Experimental: Treatment (brentuximab vedotin)
Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: Brentuximab Vedotin
Other Names:Other: Laboratory Biomarker Analysis
I. To estimate the response rate following weekly brentuximab vedotin (1.2 mg/kg 3 of 4 weeks for up to four 28-day cycles) in patients with lack of response (< partial response [PR]) or progression following brentuximab vedotin and demonstrating persistent expression of CD30.
I. To monitor clinical outcome following the study treatment regimen.
II. To estimate the frequency of CD30 loss in patients following resistance to brentuximab vedotin.
III. To describe the pattern of CD30 expression (membranous, cytoplasmic, Golgi) in comparison to the pre-brentuximab vedotin expression.
IV. To semi-quantitatively estimate and compare the surface density of CD30 pre and post brentuximab vedotin as measured by flow cytometry.
V. To correlate response with CD30 density as measured by flow cytometry.
VI. To evaluate the tolerability of the weekly regimen in patients previously exposed to brentuximab vedotin.
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3-5 weeks, every 3 months for 1 year, and then every 6 months for 4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703949
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Ajay Gopal||Fred Hutch/University of Washington Cancer Consortium|