A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/21/2018
Start Date:November 2014
End Date:August 2019

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Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

A multicenter, open-label Phase 2b study of selinexor (KPT-330) in patients with
relapsed/refractory DLBCL who have no therapeutic options of demonstrated clinical benefit.

This is a multicenter, open-label Phase 2b study of the SINE compound, selinexor. A fixed 60
mg dose of selinexor is given orally to patients with relapsed/refractory DLBCL who have no
therapeutic options of demonstrated clinical benefit. One hundred thirty patients with
relapsed/refractory DLBCL who meet eligibility criteria and have none of the exclusion
criteria will be enrolled to receive selinexor until either disease progression or
intolerance has occurred. Patients will be followed until disease progression and/or death.

Inclusion Criteria:

- Age ≥18 years

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

- Pathologically confirmed de novo DLBCL

- Objective, documented evidence of disease progression on study entry

- Have previously received at least 2 but no more than 5 previous systemic regimens for
the treatment of DLBCL

- Have measurable disease

- For patients whose most recent anti-DLBCL therapy induced a PR or CR, at least 60 days
must have elapsed since the end of that therapy. For all other patients, at least 14
weeks must have elapsed since their most recent systemic anti-DLBCL therapy

Exclusion Criteria:

- DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma
(HL+NHL) or DLBCL transformed from diseases other than indolent NHL

- Must not be eligible for high-dose therapy with autologous stem cell transplantation
rescue

- Primary mediastinal (thymic) large B-cell lymphoma (PMBL)

- Known central nervous system (CNS) lymphoma

- Active Hepatitis B or C infection

- Known human immunodeficiency virus (HIV) infection

- Unable to swallow tablets, patients with malabsorption syndrome, or any other GI
disease or GI function that could interfere with absorption of study treatment
We found this trial at
24
sites
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Andreas Klein
Phone: 617-636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Sonali M Smith, MD
Phone: 855-702-8222
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Principal Investigator: Jason Kaplan, MD
Phone: 312-695-0990
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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Chicago, IL
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Eric Jacobsen
Phone: 617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Principal Investigator: Tarun Kewalramani
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Burlington, MA
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Principal Investigator: Nashat Gabrail, MD
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Cleveland, Ohio 44106
Principal Investigator: Paolo Caimi
Phone: 800-641-2422
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Brian Hill, M.D., PhD
Phone: 216-445-9451
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Darlinghurst, New South Wales 2010
Principal Investigator: Nada Hamad, MBBS, FRACP, FRCPA
Phone: 61294804280
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Greenville, South Carolina 29615
Principal Investigator: Saeeda Chowdhury
Phone: 864-455-3600
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
Principal Investigator: Andre Goy, M.D., M.S.
Phone: 551-996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Houston, Texas 77030
Principal Investigator: Jason Westin, MD, PhD
Phone: 713-792-2171
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Lake Success, New York 11042
Principal Investigator: Morton Coleman, M.D.
Phone: 855-737-2873
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Los Angeles, California 90095
Principal Investigator: Sven de Vos, MD, PhD
Phone: 310-829-5471
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Louisville, Kentucky 40207
Principal Investigator: Joseph Maly, MD
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New York, New York
Principal Investigator: Peter Martin, MD
Phone: 646-962-8215
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Mohamad A. Cherry
Phone: 405-271-4700
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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701 Northwest 13th Street
Plantation, Florida 33486
Principal Investigator: Jason Tache, MD
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San Francisco, California 94143
Principal Investigator: C. Babis Andreadis
Phone: 415-476-1000
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Seattle, Washington 98101
Principal Investigator: David M Aboulafia
Phone: 888-862-2737
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Seattle, Washington 98104
Principal Investigator: John Pagel, MD
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Stony Brook, New York 11794
Principal Investigator: Michael Schuster, MD
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Tucson, Arizona 85704
Principal Investigator: Daniel Persky, MD
Phone: 520-694-2873
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Principal Investigator: Jan Cerny
Phone: 508-856-2557
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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