Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01703949
First received: October 8, 2012
Last updated: December 2, 2016
Last verified: December 2016

October 8, 2012
December 2, 2016
March 2013
June 2015   (final data collection date for primary outcome measure)
Overall response rate as measured by the Cheson 2007 criteria [ Time Frame: Up to 5 weeks after completion of study treatment ] [ Designated as safety issue: No ]
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%.
Same as current
Complete list of historical versions of study NCT01703949 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Brentuximab Vedotin in Treating Patients With Relapsed or Refractory CD30+ Lymphoma
A Pilot Study of Weekly Brentuximab Vedotin in Patients With CD30+ Malignancies Refractory to Every ≥ 3 Week Brentuximab Vedotin
This pilot clinical trial studies brentuximab vedotin in treating patients with CD30+ lymphoma has come base after a period of improvement or does not respond to treatment. Biological therapies, such as brentuximab vedotin, may stimulate the immune system in different ways and stop cancer cells from growing.

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • CD30-Positive Neoplastic Cells Present
  • Recurrent Hodgkin Lymphoma
  • Recurrent Non-Hodgkin Lymphoma
  • Refractory Hodgkin Lymphoma
  • Refractory Non-Hodgkin Lymphoma
  • Drug: Brentuximab Vedotin
    Given IV
    Other Names:
    • ADC SGN-35
    • Adcetris
    • Anti-CD30 Antibody-Drug Conjugate SGN-35
    • Anti-CD30 Monoclonal Antibody-MMAE SGN-35
    • Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35
    • cAC10-vcMMAE
    • SGN-35
  • Other: Laboratory Biomarker Analysis
    Correlative studies
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.
Interventions:
  • Drug: Brentuximab Vedotin
  • Other: Laboratory Biomarker Analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
8
Not Provided
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01703949
7808, NCI-2012-01696, 7808, P30CA015704
No
Not Provided
Not Provided
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Ajay Gopal Fred Hutch/University of Washington Cancer Consortium
University of Washington
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP