TGR1202 in Relapsed and Refractory Follicular Lymphoma

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Primary Outcome Measures:
Secondary Outcome Measures:

  • Progression Free Survival (PFS) after treatment with TGR-1202 [ Time Frame: Up to 3 years ]

    The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

  • Duration of Response (DoR) after treatment with TGR-1202 [ Time Frame: Up to 3 years ]

    The time of initial response until documented tumor progression.

  • Number of dose delays [ Time Frame: Up to 3 years ]

    The number of instances of patients having a dose of study drug delayed 1 or more days.

  • Number of dose reductions [ Time Frame: Up to 3 years ]

    The number of instances of patients having to reduce the dosage of study drug based on specified toxicities.

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 3 years ]

    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] broken down by adverse event and CTCAE v4.0 grade of each event.

This is an open label, phase II study of TGR-1202 in patients with relapsed or refractory Grade 1, 2, or 3A follicular lymphoma (FL). FL is the most common subtype of indolent lymphoma. The prognosis of FL depends on the histologic grade, stage, treatment and age of the patient. The disease is considered incurable with the exception of a small minority of patients with stage 1 FL who may be curable with radiation therapy. Eventually most FL patients die of lymphoma regardless of the treatment. More recently, efforts have been made to find novel regimens for the treatment of relapsed FL that do not contain non-specific cytotoxic agents.

One of the important goals of this phase II study is to discover novel genetic, biochemical, and immunological markers that are associated with the response and safety of TGR-1202 in patients with FL. TGR-1202 blocks PI3K, a signal that is required for cancer to grow.