A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

February 2, 2017 updated by: Seagen Inc.

A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • B.C Cancer Agency
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • France
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Paris, France, 75475
        • Hospital Saint Louis
      • Rouen, France, 76038
        • Centre Henri Becquerel
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute / Wayne State University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Sammons Cancer Center / Texas Oncology
      • Houston, Texas, United States, 77030-4003
        • MD Anderson Cancer Center / University of Texas
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Brentuximab vedotin
Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Names:
  • SGN-35
  • ADCETRIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate by Independent Review Group
Time Frame: up to 12 months
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.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Remission Rate by Independent Review Group
Time Frame: up to 12 months
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.
up to 12 months
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Time Frame: up to 12 months
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.
up to 12 months
Hematology Laboratory Abnormalities >/= Grade 3
Time Frame: up to 12 months
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.
up to 12 months
Chemistry Laboratory Abnormalities >/= Grade 3
Time Frame: up to 12 months
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.
up to 12 months
Area Under the Curve
Time Frame: 3 weeks
Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin
3 weeks
Maximum Serum Concentration
Time Frame: 3 weeks
Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
3 weeks
Time of Maximum Serum Concentration
Time Frame: 3 weeks
Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
3 weeks
Duration of Objective Response by Kaplan-Meier Analysis
Time Frame: up to approximately 3 years
Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.
up to approximately 3 years
Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
Time Frame: up to approximately 3 years
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.
up to approximately 3 years
Progression-free Survival by Kaplan-Meier Analysis
Time Frame: up to approximately 3 years
Time from start of study treatment to disease progression per independent review group or death due to any cause.
up to approximately 3 years
Overall Survival
Time Frame: up to approximately 7 years
Time from start of study treatment to date of death due to any cause.
up to approximately 7 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
B Symptom Resolution
Time Frame: up to 12 months
Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Millennium Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

March 19, 2009

First Posted (ESTIMATE)

March 20, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG035-0004
  • 2008-006035-12 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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