TGR1202 in Relapsed and Refractory Follicular Lymphoma

Inclusion Criteria

• •Histologically proven diagnosis of grade 1, 2, or 3A FL.
• •Relapse following first line immunotherapy or chemoimmunotherapy. There is no upper limit to the number of therapies received prior to study entry. Prior therapies may include high-dose therapy with autologous stem cell rescue.
• •Measurable Disease according to the Lugano classification.
• •Lymphoma that is amenable to safe pre-treatment and post-treatment biopsy. The safety of the procedures will be determined by the treating physician and the surgeon in consultation with the PI, and in accordance with standard clinical practice. Acceptable sites of disease include, for example: (1) palpable tumor mass that is accessible under direct visualization or sonogram, (2) non-palpable tumor tissue that is accessible for biopsy under computed tomography (CT) or sonogram guidance, (3) bone marrow.
• •Age \>18 years
• •Eastern Cooperative Oncology Group (ECOG) performance status \<2
• •Patients must have adequate organ and marrow function as defined below:
• •1. absolute neutrophil count \>1,000/microliter
• •2. platelet count ≥50,000/microliter
• •3. bilirubin \<1.5 x institutional upper limit of normal
• •4. aspartate transaminase (AST, SGOT)/alanine transaminase (ALT, SGPT) \<3.0 x institutional upper limit of normal
• •5. Serum creatinine \<2.0 x institutional upper limit of normal or creatinine clearance \>50 mL/min (according to the Cockcroft and Gault equation).
• •Negative serum pregnancy test within 7 days prior to Cycle 1/Day 1 for women of childbearing potential.
• •All women of childbearing potential must agree to use an effective barrier method of contraception, as described in Appendix 4, during the treatment period and for at least 1 month after discontinuation of the study drug. Male subjects should use effective barrier method of contraception during the treatment period and for at least 1 month after discontinuation of the study drug
• •Ability to understand and the willingness to sign a written informed consent document.
• •Unstable or severe uncontrolled medical condition (e.g. unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the patient associated with his or her participation in the study
• •Clinically significant cardiovascular abnormalities such as:
• •1. QTc ≥ 470 msec.
• •2. Angina not well-controlled by medication
• •3. Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac/vascular stenting within 6 months of enrollment
• •4. Symptomatic or documented congestive heart failure that meets New York Heart Association (NYHA) Class III to IV definitions;
• •5. History of stroke within the last 6 months prior to screening