A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Combination with Idelalisib in Subjects with Relapsed or Refractory Hematologic Malignancies
This clinical trial is a multicenter, phase 2 study. The trial will evaluate the effectiveness, safety and tolerability of the drug GS-9973 in combination with the drug Idelalisib. This trial will involve patients with relapsed or refractory hematologic malignancies.
Patients meeting all inclusion and none of the exclusion criteria will receive treatment with GS-9973 and idelalisib
Chronic Lymphocytic Leukemia
Mantle cell lymphoma
Diffuse large B-cell lymphoma
Small Lymphocytic Lymphoma
Marginal Zone Lymphoma
*Diagnosis of B-cell iNHL, DLBCL, MCL, or CLL
*Prior treatment for lymphoid malignancy
*Should not have a known histological transformation from iNHL or CLL to an
aggressive form of NHL
*Should not have a known active central nervous system or leptomeningeal
*Should not have a known presence of known intermediate- or high-grade myelodysplastic syndrome
* Should not have an ongoing infection
* Should not have liver injuries, liver disease(s), cholelithiasis or cirrhosis of the liver
* Should not be positive for Hepatitis C (HCV), Hepatits B (HBV)
* Should not have ongoing drug-induced pneumonia.
* Should not have ongoing inflammatory bowel disease.
* Should not have ongoing alcohol or drug addiction.
*Should not have history of prior allogeneic bone marrow progenitor cell or
solid organ transplantation
18 - 100
Healthy Volunteers Needed
Duration of Participation
Study drug will be taken until one of the following happens:
* Withdrawal from the study
* Progression of cancer
* Unbearable study drug-related toxicity
* Repeated inability to complete study procedures
* Study ends
Clinical Trials Information Line: Phone 503-494-1080 or email@example.com
Gilead Sciences, Inc.