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

NCT ID: NCT01786135

Last Updated: 2017-10-19

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-02-16

Brief Summary

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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)

Detailed Description

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Conditions

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Burkitt Lymphoma Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Precursor B-cell Lymphoblastic Leukemia-Lymphoma

Keywords

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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

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-CD19A

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

Group Type EXPERIMENTAL

SGN-CD19A

Intervention Type DRUG

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

Interventions

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SGN-CD19A

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

12 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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Ana Kostic, MD

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

Stanford Cancer Center

Stanford, California, United States

Site Status

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

MD Anderson Cancer Center / University of Texas

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SGN19A-002

Identifier Type: -

Identifier Source: org_study_id