A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
Status: | Terminated |
---|---|
Conditions: | Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/15/2018 |
Start Date: | February 2016 |
End Date: | July 10, 2018 |
A Phase 1, Open-label, Dose-escalation Study of SGN-CD19B in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
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.
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.
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.
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.
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
We found this trial at
16
sites
330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-5982
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Principal Investigator: Andres Forero-Torres
Phone: 205-975-0960
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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201 Presidents Circle
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Ahmad Halwani
Phone: 801-585-0303
University of Utah Research is a major component in the life of the U benefiting...
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Eric Jacobsen
Phone: 617-632-5221
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Charleston, South Carolina 29425
Principal Investigator: Robert Stuart
Phone: 843-792-1463
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Cleveland, Ohio 44195
Principal Investigator: Deepa Jagadeesh
Phone: 216-445-9451
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Lihua Elizabeth Budde
Phone: 626-218-0478
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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30 Prospect Ave
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Tatyana Feldman
Phone: 201-996-5952
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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4500 San Pablo Rd S
Jacksonville, Florida 32224
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: Han Tun
Phone: 904-953-7290
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Madison, Wisconsin
Principal Investigator: Vaishalee Kenkre
Phone: 608-263-1836
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2160 S. First Ave.
Maywood, Illinois 60153
Maywood, Illinois 60153
888-584-7888
Principal Investigator: Patrick Stiff
Phone: 708-327-3227
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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New York, New York 10016
Principal Investigator: Catherine Diefenbach
Phone: 212-263-4415
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Craig Moskowitz
Phone: 212-639-2696
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Seyfettin Onder-Alpdogan, MD
Phone: 203-785-4095
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Rochester, Minnesota 55905
Principal Investigator: Grzegorz Nowakowski
Phone: 507-284-4740
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Seattle, Washington 98109
Principal Investigator: Stephen Smith
Phone: 206-288-6448
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