Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of GS-9901 in Adults With Relapsed or Refractory Follicular Lymphoma, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Lymphoma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of FL, MZL, SLL, or CLL (meeting International Workshop on CLL \[IWCLL\] Criteria, 2008) as documented by medical records and with histology based on criteria established by the World Health Organization
* FL Grades 1, 2, or 3a
* SLL with absolute lymphocyte count of \< 5 x 10\^9/L at initial diagnosis
* MZL (splenic, nodal, or extra-nodal)
Prior treatment for FL or CLL/SLL with ≥ 1 prior chemotherapy-based or immunotherapy-based regimen with no approved therapies available
Presence of radiographically measurable lymphadenopathy or extra nodal lymphoid malignancy
All acute toxic effects of any prior antitumor therapy resolved to Grade ≤1 before the start of study therapy (with the exception of alopecia \[Grade 1 or 2 permitted\], or bone marrow parameters \[any of Grade 1, 2, or 3 permitted)
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Able to provide written informed consent
You may not be if
History of lymphoid malignancy other than FL, MZL, SLL, or CLL
History of myelodysplastic syndrome
History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to start of study therapy, or any other cancer that has been in complete remission for ≥ 5 years
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study therapy
Ongoing drug-induced pneumonitis
Ongoing inflammatory bowel disease
History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
History of prior therapy with any inhibitor of serine/threonine kinase (AKT), Bruton tyrosine kinase (BTK), Janus kinase (JAK), mammalian target of rapamycin (mTOR), phosphatidylinositol 3-kinase (PI3K), or spleen tyrosine kinase (SYK)
Ongoing immunosuppressive therapy, including systemic corticosteroids for treatment of lymphoid malignancy
Clareo Health | Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of GS-9901 in Adults With Relapsed or Refractory Follicular Lymphoma, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Lymphoma
