Clinical trial NCT01421667: A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma
Official title: A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Keywords: Lymphoma, Large B-Cell, Diffuse
Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Lymphoma, Non-Hodgkin
Monomethyl auristatin E
Drug Therapy
Immunotherapy
Hematologic Diseases
Lymphoma
Lymphoma, B-Cell
Lymphoma, T-Cell
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-23
Enrollment: 176
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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
* Eastern Cooperative Oncology Group (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

Primary outcomes:
measure: Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy
timeFrame: Up to approximately 3 years
measure: Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
timeFrame: Up to 3 years
Secondary outcomes:
measure: Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab
timeFrame: Up to approximately 3 years
measure: Complete Remission (CR) Rate by Investigator
timeFrame: Up to approximately 3 years
measure: Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
timeFrame: Up to approximately 3 years
measure: Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
timeFrame: Up to approximately 3 years
measure: Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
timeFrame: Up to approximately 3 years
measure: Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression
timeFrame: Up to 3 years
measure: Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
timeFrame: Up to 3 years
measure: Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)
timeFrame: 1 day
measure: Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)
timeFrame: 3 weeks
measure: Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)
timeFrame: 3 weeks
measure: Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
timeFrame: 3 weeks
measure: Baseline Soluble CD30 Expression
timeFrame: Baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope
state: California
city: Oxnard
country: United States
facility: PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: St. Augustine
country: United States
facility: Cancer Specialists of North Florida - St. Augustine
state: Florida
city: Atlanta
country: United States
facility: Emory Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology P.A.
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: New York
country: United States
facility: NYU Clinical Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic, The
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer and Research / USOR
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: St. Francis Hospital
state: South Carolina
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Charles A. Sammons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology-Southwest Fort Worth
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
city: Round Rock
country: United States
facility: Texas Oncology - Seton Williamson
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Edmonds
country: United States
facility: Swedish Cancer Institute Medical Oncology
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance / University of Washington Medical Center
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Centre
state: British Columbia
Study officials:
affiliation: Seagen Inc.
name: Corinna Palanca-Wessels, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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-2013-12-542142. Epub 2014 Mar 20.
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 CD30 expression. Blood. 2015 Feb 26;125(9):1394-402. doi: 10.1182/blood-2014-09-598763. Epub 2015 Jan 8.
citation: Bartlett NL, Smith MR, Siddiqi T, Advani RH, O'Connor OA, Sharman JP, Feldman T, Savage KJ, Shustov AR, Diefenbach CS, Oki Y, Palanca-Wessels MC, Uttarwar M, Li M, Yang J, Jacobsen ED. Brentuximab vedotin activity in diffuse large B-cell lymphoma with CD30 undetectable by visual assessment of conventional immunohistochemistry. Leuk Lymphoma. 2017 Jul;58(7):1607-1616. doi: 10.1080/10428194.2016.1256481. Epub 2016 Nov 20.