Clinical trial NCT00866047: A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma
Official title: A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Keywords: Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
monomethyl auristatin E
Drug Therapy
Immunotherapy
Hematologic Diseases
Lymphoma
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2009-03-20
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.


Eligibility criteria: Inclusion Criteria:

* Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
* Documented anaplastic lymphoma kinase (ALK) status.
* Histologically-confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
* Fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
* Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
* At US sites, patients greater than or equal to 12 years of age may be enrolled. At non-US sites, patients must be greater than or equal to 18 years of age.

Exclusion Criteria:

* Previous treatment with brentuximab vedotin.
* Previously received an allogeneic transplant.
* Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
* Known cerebral/meningeal disease.

Primary outcomes:
measure: Objective Response Rate by Independent Review Group
timeFrame: up to 12 months
Secondary outcomes:
measure: Complete Remission Rate by Independent Review Group
timeFrame: up to 12 months
measure: Duration of Objective Response by Kaplan-Meier Analysis
timeFrame: up to approximately 3 years
measure: Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
timeFrame: up to approximately 3 years
measure: Progression-free Survival by Kaplan-Meier Analysis
timeFrame: up to approximately 3 years
measure: Overall Survival
timeFrame: up to approximately 7 years
measure: Adverse Events by Severity, Seriousness, and Relationship to Treatment
timeFrame: up to 12 months
measure: Hematology Laboratory Abnormalities >/= Grade 3
timeFrame: up to 12 months
measure: Chemistry Laboratory Abnormalities >/= Grade 3
timeFrame: up to 12 months
measure: Area Under the Curve
timeFrame: 3 weeks
measure: Maximum Serum Concentration
timeFrame: 3 weeks
measure: Time of Maximum Serum Concentration
timeFrame: 3 weeks
Other outcomes:
measure: B Symptom Resolution
timeFrame: up to 12 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Detroit
country: United States
facility: Karmanos Cancer Institute / Wayne State University
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Dallas
country: United States
facility: Baylor Sammons Cancer Center / Texas Oncology
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Vancouver
country: Canada
facility: B.C Cancer Agency
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Paris
country: France
facility: Hospital Saint Louis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS
Study officials:
affiliation: Seagen Inc.
name: Dana Kennedy, PharmD
role: STUDY_DIRECTOR
References:
citation: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. doi: 10.1200/JCO.2011.38.0402. Epub 2012 May 21.
citation: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. doi: 10.1182/blood-2017-05-780049. Epub 2017 Oct 3.