A Safety Study of SGN-CD19A for B-Cell Lymphoma

October 17, 2017 updated by: Seagen Inc.

A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma

This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope National Medical Center
      • Stanford, California, United States, 94305
        • Stanford Cancer Center
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
    • Texas
      • Houston, Texas, United States, 77030-4095
        • MD Anderson Cancer Center / University of Texas

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 (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma Grade 3, diffuse large B-cell lymphoma (DLBCL), including transformed follicular histology, Burkitt lymphoma, or B-lineage lymphoblastic lymphoma
  • Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy. Patients with DLBCL or follicular lymphoma Grade 3 must have also received intensive salvage therapy.
  • Eastern Cooperative Oncology Group status of 0 or 1
  • Measurable disease

Exclusion Criteria:

  • Allogeneic stem cell transplant (SCT)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SGN-CD19A
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
Drug: SGN-CD19A
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Through 1 month post last dose
Through 1 month post last dose
Incidence of laboratory abnormalities
Time Frame: Through 1 month post last dose
Through 1 month post last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Until death or study closure, an expected average of 1 year
Until death or study closure, an expected average of 1 year
Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)
Time Frame: Through up to approximately 6 week post last dose
Through up to approximately 6 week post last dose
Duration of response
Time Frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months
Until disease progression or start of new anticancer treatment, an expected average of 6 months
Blood concentration of SGN-CD19A and metabolites
Time Frame: Through up to approximately 6 weeks post last dose
Through up to approximately 6 weeks post last dose
Incidence of antitherapeutic antibodies
Time Frame: Through up to approximately 6 weeks post last dose
Through up to approximately 6 weeks post last dose

Collaborators and Investigators

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

Sponsor

Seagen Inc.

Investigators

  • Study Director: Ana Kostic, MD, Seagen Inc.

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

February 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

February 16, 2017

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 17, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN19A-002

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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