Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies



Status:Active, not recruiting
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/13/2019
Start Date:March 14, 2013
End Date:May 2019

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A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects With Relapsed or Refractory Hematologic Malignancies

This study will evaluate the efficacy, safety, tolerability, and pharmacodynamics of
entospletinib. Participants with the following relapsed or refractory hematologic
malignancies will be enrolled into the study: relapsed or refractory chronic lymphocytic
leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular
lymphoma (FL), or non-FL indolent non-Hodgkin lymphomas (iNHL; including lymphoplasmacytoid
lymphoma/ Waldenström macroglobulinemia [LPL/WM], small lymphocytic lymphoma [SLL], or
marginal zone lymphoma [MZL]).


Key Inclusion Criteria:

- Diagnosis of B-cell iNHL, DLBCL, MCL, or CLL as documented by medical records and with
histology based on criteria established by the World Health Organization

- For institutions that have Phase 3 or Phase 4 protocols studying idelalisib (Zydelig®)
; individuals with malignancies being studied in these protocols must have failed
screening in the respective idelalisib protocol

- Prior treatment for lymphoid malignancy requiring treatment for progressive disease

- Presence of radiographically measurable lymphadenopathy or extranodal lymphoid
malignancy

- All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before
the start of study drug

- Karnofsky performance status of ≥ 60

- Life expectancy of at least 3 months

Key Exclusion Criteria:

- Known histological transformation from iNHL or CLL to an aggressive form of
non-Hodgkin lymphoma (ie, Richter transformation) except if the CLL patient is
enrolling in the B-cell receptor (BCR) previously treated cohort

- Known active central nervous system or leptomeningeal lymphoma

- Presence of known intermediate- or high-grade myelodysplastic syndrome

- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of
start of study drug

- Ongoing liver injury

- Ongoing or recent hepatic encephalopathy

- Ongoing drug-induced pneumonitis

- Ongoing inflammatory bowel disease

- Ongoing alcohol or drug addiction

- Pregnancy or breastfeeding

- History of prior allogeneic bone marrow progenitor cell or solid organ transplantation

- Ongoing immunosuppressive therapy

- Concurrent participation in an investigational drug trial with therapeutic intent

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
47
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Michael Thirman
Phone: 773-702-2084
University of Chicago One of the world's premier academic and research institutions, the University of...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Andres Forero-Torres, MD
Phone: 205-934-0337
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Andreas Klein, MD
Phone: 617-636-2683
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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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Brian Hill, MD
Phone: 216-444-4432
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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3700 Johnson Street
Hollywood, Florida 33021
Principal Investigator: Alvaro Alencar, MD
Phone: 954-965-6390
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433 Southwest 10th Street
Ocala, Florida 34471
Principal Investigator: Rama Balaraman, MD
Phone: 352-732-4938
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Andrei Shustov, MD
Phone: 206-288-1172
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Daniel Lebovic, MD
Phone: 734-936-3879
University of Michigan Health System The University of Michigan is home to one of the...
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Rodolofo Bordoni, MD
Phone: 770-496-9419
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Austin, Texas 78705
Principal Investigator: Jason Melear, MD
Phone: 512-614-5935
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Barrie, Ontario
Principal Investigator: Derek Nay, MD
Phone: 705-728-9090
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Baton Rouge, Louisiana 70809
Principal Investigator: Michael Castine, MD
Phone: 225-761-3951
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Boulder, Colorado 80303
Principal Investigator: David Andorsky, MD
Phone: 303-388-4876
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Canton, Ohio 44718
Principal Investigator: Nashat Gabrail
Phone: 330-492-3345
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Catherine Coombs, MD
Phone: 919-966-4432
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Principal Investigator: James Essell, MD
Phone: 513-751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Columbus, Ohio 43210
Principal Investigator: Farrukh Awan, MD
Phone: 614-366-0372
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Dallas, Texas 75201
Principal Investigator: Jay Courtright, MD
Phone: 972-566-4291
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Denver, Colorado 80205
Principal Investigator: Alex Menter
Phone: 303-764-5056
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Detroit, Michigan 48201
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Robert Chen, MD
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Dipti Patel-Donnelly, MD
Phone: 703-280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Florham Park, New Jersey 07932
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8931 Colonial Center Drive
Fort Myers, Florida 33905
Principal Investigator: Lowell Hart, MD
Phone: 239-938-0800
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Fort Worth, Texas 76104
Principal Investigator: Ray Page, DO, PhD
Phone: 817-759-7023
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Germantown, Tennessee 38138
Principal Investigator: Clyde Jones, MD
Phone: 901-685-5969
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Hattiesburg, Mississippi 39401
Principal Investigator: John Hrom, MD
Phone: 601-288-2495
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Indianapolis, Indiana 46202
Principal Investigator: Jose Azar, MD
Phone: 317-274-2992
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7360 W. Deschutes
Kennewick, Washington 99336
509-783-0144
Principal Investigator: Thomas Rado, MD
Phone: 509-783-4637
Columbia Basin Hematology and Oncology Our collaboration with Seattle Cancer Care Alliance gives you convenient...
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Lawrenceville, Georgia 30046
Principal Investigator: Christopher Hagenstad, MD
Phone: 678-533-1567
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1 Medical Center Drive
Lebanon, New Hampshire 03756
Principal Investigator: Frederick Lansigan, MD
Phone: 603-650-5529
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Marietta, Georgia 30060
Principal Investigator: Dean Kirkel, MD
Phone: 770-281-5131
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Minneapolis, Minnesota 55405
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Ian Flinn, MD, PhD
Phone: 615-524-4127
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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New York, New York 10021
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Niles, Illinois 60714
Principal Investigator: Leonard Klein, MD
Phone: 847-827-9060
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Omaha, Nebraska 68130
Principal Investigator: Stefano Tarantolo, MD
Phone: 402-691-6971
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Richmond, Virginia 23235
Principal Investigator: James Khatcheressian, MD
Phone: 804-288-7159
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San Antonio, Texas 78217
Principal Investigator: Allyson Harroff, MD
Phone: 210-656-7177
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San Antonio, Texas 78229
Principal Investigator: Roger Lyons, MD
Phone: 281-863-4896
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7901 Frost Street
San Diego, California 92123
858-939-3400
Principal Investigator: Alfred Saleh, MD
Phone: 858-939-5067
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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Southington, Connecticut 06489
Principal Investigator: Peter Byeff, MD
Phone: 860-621-9316
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Springfield, Oregon 97477
Principal Investigator: Jeff Sharman, MD
Phone: 541-741-3451
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Tucson, Arizona 85745
Principal Investigator: Christopher Di Simone, MD
Phone: 520-886-0206
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Vancouver, Washington 98684
Principal Investigator: Kathryn Kolibaba, MD
Phone: 360-449-6521
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Watertown, South Dakota
Principal Investigator: Bipinkumar Amin, MD
Phone: 605-882-6800
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2811 Tieton Drive
Yakima, Washington 98902
Principal Investigator: Thomas Giever, MD
Phone: 509-574-3493
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