A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421667
• Other study ID #: SGN35-012
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2011
• Last updated: June 22, 2015
• Start date: August 2011
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Histologically-confirmed NHL (DLBCL only for Parts B and C)

• Relapsed or refractory disease following at least 1 prior systemic therapy

• Measurable disease of at least 1.5 cm as documented by CT

• ECOG performance status less than or equal to 2

Exclusion Criteria:

• History of another primary invasive malignancy that has not been in remission for at least 3 years

• Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides

• B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy

• Known cerebral/meningeal disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell

Intervention

Drug:
• brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
• rituximab
375 mg/m2 every 3 weeks by IV infusion

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency - Vancouver Centre	Vancouver	British Columbia
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	Emory Winship Cancer Institute	Atlanta	Georgia
United States	Rocky Mountain Cancer Centers - Aurora	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic, The	Cleveland	Ohio
United States	Charles A. Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology - Medical City Dallas	Dallas	Texas
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	City of Hope	Duarte	California
United States	Swedish Cancer Institute Medical Oncology	Edmonds	Washington
United States	Willamette Valley Cancer and Research / USOR	Eugene	Oregon
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	Texas Oncology-Southwest Fort Worth	Fort Worth	Texas
United States	St. Francis Hospital	Greenville	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Minnesota Oncology Hematology P.A.	Minneapolis	Minnesota
United States	Columbia University Medical Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	NYU Clinical Cancer Center	New York	New York
United States	PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists	Oxnard	California
United States	Texas Oncology - Seton Williamson	Round Rock	Texas
United States	Seattle Cancer Care Alliance / University of Washington Medical Center	Seattle	Washington
United States	Cancer Specialists of North Florida - St. Augustine	St. Augustine	Florida
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Stanford Cancer Center	Stanford	California
United States	Texas Oncology - Tyler	Tyler	Texas
United States	Northwest Cancer Specialists, P.C.	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. doi: 10.1182/blood-2013-12 — View Citation

Jacobsen ED, Sharman JP, Oki Y, Advani RH, Winter JN, Bello CM, Spitzer G, Palanca-Wessels MC, Kennedy DA, Levine P, Yang J, Bartlett NL. Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate with brentuximab vedotin		Through 1 month following last dose	No
Primary	Incidence of adverse events with brentuximab vedotin + rituximab		Through 1 month following last dose	Yes
Primary	Incidence of laboratory abnormalities with brentuximab vedotin + rituximab		Through 1 month following last dose	Yes
Secondary	Incidence of adverse events with brentuximab vedotin		Through 1 month following last dose	Yes
Secondary	Incidence of laboratory abnormalities with brentuximab vedotin		Through 1 month following last dose	Yes
Secondary	Correlation between CD30 expression and antitumor activity with brentuximab vedotin		Through 1 month following last dose	No
Secondary	Duration of response		Until disease progression or study closure	No
Secondary	Progression-free survival		Until disease progression or study closure	No
Secondary	Area under the plasma concentration versus time curve (AUC)		Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion	No
Secondary	Peak plasma concentration (Cmax)		Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion	No
Secondary	Plasma concentration at end of infusion (Ceoi)		Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion	No
Secondary	Pharmacodynamic (PD) biomarkers		Pre-dose at each cycle	No
Secondary	Objective response rate with brentuximab vedotin + rituximab		Through 1 month following last dose	No
Secondary	Complete remission (CR) rate		Through 1 month following last dose	No