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A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin 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.
 
ClinicalTrials.gov Identifier: NCT02702141
Recruitment Status : Terminated
First Posted : March 8, 2016
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
The study will examine the safety profile of SGN-CD19B administered as a single agent. The main purpose of the study is to estimate the highest dose that does not cause unacceptable side effects of SGN-CD19B in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) subtypes of diffuse large B-cell lymphoma (DLBCL) and Grade 3 follicular lymphoma (FL3). Additionally, the pharmacokinetic profile and antitumor activity of SGN-CD19B will be assessed.

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma DLBCL Diffuse Large B-cell Lymphoma Grade 3 Follicular Lymphoma Drug: SGN-CD19B Phase 1

Detailed Description:

SGN-CD19B will be given to patients at increasing doses every 28 days (or on an alternative dosing schedule of every 42 days).

Individual expansion cohorts of up to approximately 20 patients will be opened at dose levels selected by the Safety Monitoring Committee based on the aggregate known safety and activity data to further define the safety and antitumor activity in refractory and relapsed disease subgroups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 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-CD19B in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
Actual Study Start Date : February 2016
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : July 10, 2018


Arm Intervention/treatment
Experimental: SGN-CD19B Drug: SGN-CD19B
Given intravenously Day 1 of 28-day or 42-day cycles




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Through 1 month following last dose ]
  2. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]

Secondary Outcome Measures :
  1. Blood concentrations of SGN-CD19B [ Time Frame: Through 3 weeks after dosing ]
  2. Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose ]
  3. Objective response rate [ Time Frame: Through 1 month following last dose ]
  4. Rate of response [ Time Frame: Through 1 month following last dose ]
  5. Progression-free survival [ Time Frame: Up to approximately 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies
  • Measurable disease
  • Eastern Cooperative Oncology Group status of 0 or 1
  • Adequate baseline renal and hepatic function

Exclusion Criteria:

  • Prior treatment with CD19 directed agents unless CD19 expression is confirmed after completion of CD19-directed treatment
  • Known HIV, active hepatitis B or active hepatitis C infection
  • Prior allogeneic stem cell transplant
  • Inadequate lung function
  • Anticancer treatment within 4 weeks of study drug or 2 weeks if patient experienced disease progression on prior treatment

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 ClinicalTrials.gov identifier (NCT number): NCT02702141


Locations
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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
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
United States, Illinois
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
New York University (NYU) Cancer Institute
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
Cleveland Clinic, The
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina/Hollings Cancer Center
Charleston, South Carolina, United States, 29425
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States, 98109-1023
United States, Wisconsin
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, United States, United States
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: Juan Pinelli, PA-C, MMSc Seattle Genetics, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02702141    
Other Study ID Numbers: SGN19B-001
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Keywords provided by Seattle Genetics, Inc.:
Non-hodgkin lymphoma
Antibody-drug conjugate
CD19
Diffuse large B-cell lymphoma
DLBCL
Grade 3 follicular lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases