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

NCT ID: NCT02702141

Last Updated: 2018-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-07-10

Brief Summary

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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

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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.

Conditions

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Non-Hodgkin Lymphoma DLBCL Diffuse Large B-cell Lymphoma Grade 3 Follicular Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SGN-CD19B

Group Type EXPERIMENTAL

SGN-CD19B

Intervention Type DRUG

Given intravenously Day 1 of 28-day or 42-day cycles

Interventions

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SGN-CD19B

Given intravenously Day 1 of 28-day or 42-day cycles

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seagen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan Pinelli, PA-C, MMSc

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

City of Hope National Medical Center

Duarte, California, United States

Site Status

Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Cardinal Bernardin Cancer Center / Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

New York University (NYU) Cancer Institute

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Cleveland Clinic, The

Cleveland, Ohio, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina/Hollings Cancer Center

Charleston, South Carolina, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, United States

Site Status

Carbone Cancer Center / University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28903943 (View on PubMed)

Other Identifiers

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SGN19B-001

Identifier Type: -

Identifier Source: org_study_id

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