Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies

  • Interventional
  • Not Recruiting
  • NCT01799889
Eligibility Details Visit Clinicaltrials.gov

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]).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT01799889

IRB#IRB15-0132

Lead SponsorGilead Sciences

Lead PhysicianMichael J. Thirman

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting