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A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma

Primary Purpose

Non-Hodgkin Lymphoma, DLBCL, Diffuse Large B-cell Lymphoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGN-CD19B
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma focused on measuring Non-hodgkin lymphoma, Antibody-drug conjugate, CD19, Diffuse large B-cell lymphoma, DLBCL, Grade 3 follicular lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • City of Hope National Medical Center
  • Mayo Clinic Florida
  • Cardinal Bernardin Cancer Center / Loyola University Medical Center
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute
  • Mayo Clinic Minnesota
  • Hackensack University Medical Center
  • New York University (NYU) Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Cleveland Clinic, The
  • Thomas Jefferson University
  • Medical University of South Carolina/Hollings Cancer Center
  • University of Utah
  • Seattle Cancer Care Alliance / University of Washington
  • Carbone Cancer Center / University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SGN-CD19B

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events
Incidence of laboratory abnormalities

Secondary Outcome Measures

Blood concentrations of SGN-CD19B
Incidence of antitherapeutic antibodies
Objective response rate
Rate of response
Progression-free survival

Full Information

First Posted
February 25, 2016
Last Updated
August 9, 2018
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02702141
Brief Title
A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
February 2016 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
July 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma, DLBCL, Diffuse Large B-cell Lymphoma, Grade 3 Follicular Lymphoma
Keywords
Non-hodgkin lymphoma, Antibody-drug conjugate, CD19, Diffuse large B-cell lymphoma, DLBCL, Grade 3 follicular lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SGN-CD19B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SGN-CD19B
Intervention Description
Given intravenously Day 1 of 28-day or 42-day cycles
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
Through 1 month following last dose
Title
Incidence of laboratory abnormalities
Time Frame
Through 1 month following last dose
Secondary Outcome Measure Information:
Title
Blood concentrations of SGN-CD19B
Time Frame
Through 3 weeks after dosing
Title
Incidence of antitherapeutic antibodies
Time Frame
Through 1 month following last dose
Title
Objective response rate
Time Frame
Through 1 month following last dose
Title
Rate of response
Time Frame
Through 1 month following last dose
Title
Progression-free survival
Time Frame
Up to approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Pinelli, PA-C, MMSc
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Cardinal Bernardin Cancer Center / Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
New York University (NYU) Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cleveland Clinic, The
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina/Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Seattle Cancer Care Alliance / University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
Carbone Cancer Center / University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
United States
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28903943
Citation
Ryan MC, Palanca-Wessels MC, Schimpf B, Gordon KA, Kostner H, Meyer B, Yu C, Van Epps HA, Benjamin D. Therapeutic potential of SGN-CD19B, a PBD-based anti-CD19 drug conjugate, for treatment of B-cell malignancies. Blood. 2017 Nov 2;130(18):2018-2026. doi: 10.1182/blood-2017-04-779389. Epub 2017 Sep 13.
Results Reference
derived

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A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma

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