A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

Seagen Inc.102 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Disease, Hodgkin

Interventions

brentuximab vedotinDRUG

1.8 mg/kg every 3 weeks by intravenous infusion

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant. * 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 disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography. * 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. * Congestive heart failure, Class III or IV, by the New York Heart Association criteria. * History of another primary malignancy that has not been in remission for at least 3 years. * Known cerebral/meningeal disease.

Locations (27)

Outcomes

Primary Outcomes

Objective Response Rate by Independent Review Group

Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Time frame: up to 12 months

Secondary Outcomes

Complete Remission Rate by Independent Review Group

Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Time frame: up to 12 months

Duration of Objective Response by Kaplan-Meier Analysis

Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.

Time frame: up to approximately 4 years

Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis

Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.

Time frame: up to approximately 4 years

Progression-free Survival by Kaplan-Meier Analysis

Time from start of study treatment to disease progression per independent review group or death due to any cause.

Time frame: up to approximately 4 years

Overall Survival

Time from start of study treatment to date of death due to any cause.

Time frame: up to approximately 6 years

Data from ClinicalTrials.gov

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University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope National Medical Center

Duarte, California, United States

University of California at Los Angeles

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Georgetown University

Washington D.C., District of Columbia, United States

University of Miami

Miami, Florida, United States

Loyola University Medical Center Cardinal Bernardin Cancer Center

Maywood, Illinois, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

...and 17 more locations

Adverse Events by Severity, Seriousness, and Relationship to Treatment

Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.

Time frame: up to 12 months

Hematology Laboratory Abnormalities >/= Grade 3

Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

Time frame: up to 12 months

Chemistry Laboratory Abnormalities >/= Grade 3

Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

Time frame: up to 12 months

Area Under the Curve

Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin

Time frame: 3 weeks

Maximum Serum Concentration

Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

Time frame: 3 weeks

Time of Maximum Serum Concentration

Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

Time frame: 3 weeks