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Completed

NCT Number: NCT01786135

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

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Key information

Conditions

Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor B-Cell Lymphoblastic Leukemia-Lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Tumor Virus Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SGN-CD19A

Drug

SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)

Primary outcomes

  1. Incidence of adverse events

    Time frame: Through 1 month post last dose

  2. Incidence of laboratory abnormalities

    Time frame: Through 1 month post last dose

Secondary outcomes

  1. Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)

    Time frame: Through up to approximately 6 week post last dose

  2. Duration of response

    Time frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months

  3. Overall survival

    Time frame: Until death or study closure, an expected average of 1 year

  4. Blood concentration of SGN-CD19A and metabolites

    Time frame: Through up to approximately 6 weeks post last dose

  5. Incidence of antitherapeutic antibodies

    Time frame: Through up to approximately 6 weeks post last dose

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Feb 7, 2013
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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