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GS-9973 in Subjets with Hematologic Malignancies


Title A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies
Therapeutic Area Hematologic Malignancies, Chronic Lymphocytic Leukemia, Lymphomas (adult), Mantle Cell Lymphoma
Principal Investigator Andreas Klein, MD
Min Age 18 Years
Gender Both
Contact Liz Kendricken, RN
617-636-5558

Overview

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

Study Details

Inclusion Criteria

  • Participants with diagnosis of B-cell iNHL, DLBCL, MCL, or CLL
  • Prior treatment for lymphoid malignancy

Exclusion Criteria

  • Presence of known intermediate- or high-grade myelodysplastic syndrome
  • Known active central nervous system or leptomeningeal lymphoma

Study Requirements

Taking part in this study will generally last until the cancer has progressed or the participant decides to withdraw from the study.  During this time, participants will be required to visit the clinic once for screening, 4 times during the first cycle, twice during the second cycle, once for every cycle after that.  Participants may be able to continue taking the study drug at disease progression if the study doctor decides it is appropriate.  When participation has ended, the study doctor will conduct an end of study visit. Participants will have blood draws, ECG, CT and other test required for the study.