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Columbia University Medical Center AAAR1223: Phase II study of the phosphoinositide-3-kinase-delta inhibitor TGR-1202 in patients with relapsed or refractory follicular lymphoma

Description

The purpose of this open-label study is to determine the effects of TGR-1202 in patients with relapsed or refractory follicular lymphoma.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of the study is to determine the overall response rate of TGR-1202 in patients with relapsed or refractory follicular lymphoma.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who have:

  • Histologically proven diagnosis of grade 1, 2 or 3A follicular lymphoma
  • Relapsed 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
  • Lymphoma that is amenable to safe pre-treatment and post-treatment biopsy (Acceptable sites of disease include, for example: palpable tumor mass that is accessible under direct visualization or sonogram; non-palpable tumor tissue that is accessible for biopsy under CT or sonogram guidance; bone marrow.)
  • Older than 18 years old

Excluding patients who have:

  • Grade 3B follicular lymphoma or evidence of transformation to a more aggressive lymphoma
  • Had prior and concomitant therapy:
    • Prior exposure to any PI3 kinase inhibitor
    • Exposure to chemotherapy, radiotherapy, or immunotherapy within three weeks prior to entering the study or lack of recovery from adverse events (AE) due to previously administered treatments
    • Ongoing chronic immunosuppressants (e.g. cyclosporine) or systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone prior to the start of the study drug
    • Other concurrent investigational agents during the study period.
  • Had prior allogeneic stem cell transplant
  • Central nervous system lymphoma, including lymphomatous meningitis
  • Acute intercurrent illness including, but not limited to, active infection, unstable congestive heart failure, unstable angina pectoris, psychiatric illness or any social situation that would limit compliance with study participation requirements in the judgement of the investigator
  • Clinically significant cardiovascular abnormalities such as:
    • QTc ≥ 470 msec.
    • Angina not well-controlled by medication
    • Poorly controlled or clinically significant atherosclerotic vascular disease, including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac/vascular stenting within six months of enrollment
    • Symptomatic or documented congestive heart failure that meets New York Heart Association (NYHA) Class III to IV definitions (see Appendix 6)
    • History of stroke within the last six months prior to screening