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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01786135
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Burkitt Lymphoma Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Precursor B-cell Lymphoblastic Leukemia-Lymphoma Drug: SGN-CD19A Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma
Study Start Date : February 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : February 16, 2017

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)

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01786135

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030-4095
Sponsors and Collaborators
Seattle Genetics, Inc.
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Study Director: Ana Kostic, MD Seattle Genetics, Inc.
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Responsible Party: Seattle Genetics, Inc. Identifier: NCT01786135    
Other Study ID Numbers: SGN19A-002
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: June 2017
Keywords provided by Seattle Genetics, Inc.:
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD19
B-Lineage Lymphoblastic Lymphoma
Burkitt Lymphoma
Diffuse Large B-Cell Lymphoma
Mantle Cell Lymphoma
B-Cell Lymphoma
Drug Therapy
Monomethylauristatin F
Follicular Lymphoma Grade 3
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections