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Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies

Status
Completed
Cancer Type
Leukemia
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT01799889
Protocol IDs
GS-US-339-0102 (primary)
Study Sponsor
Gilead

Summary

The primary objective of the study is to evaluate efficacy of entospletinib in participants
with relapsed or refractory hematologic malignancies. 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]).

Eligibility

  1. 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
  2. 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
  3. Prior treatment for lymphoid malignancy requiring treatment for progressive disease
  4. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
  5. All acute toxic effects of any prior antitumor therapy resolved to Grade = 1 before the start of study drug
  6. Karnofsky performance status of = 60
  7. Life expectancy of at least 3 months

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Austell


1700 Hospital South Drive
Suite 300
Austell, GA 30106
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Sujatha Hariharan MD
Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen


200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton


157 Clinic Avenue
Suite 101
Carrollton, GA 30117
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville


100 Market Place Boulevard
Suite 200
Cartersville, GA 30121
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Satyen R. Mehta MD
Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville


6002 Professional Parkway
Suite 220
Douglasville, GA 30134
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Navin P. Wadehra MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper


1020 J.L. White Drive
Suite 160
Jasper, GA 30143
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Curtis R. Miles MD

Northwest Georgia Oncology Centers - Paulding


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica


705 Dallas Highway
Suite 204
Villa Rica, GA 30180
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Randall E. Pierce MD
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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