Joint Clinical Trials Office

You are here

A Phase 2 Study to Assess the Efficacy and Safety of TGR-1202 (Umbralisib) Monotherapy in Patients with Non-Follicular Indolent Non-Hodgkin’s Lymphoma

Clinical Trial Details

This clinical trial is for men and women age 18 and older with B-cell non-follicular indolent non-Hodgkin’s lymphoma. Relapsed and refractory indolent non-Hodgkin’s lymphomas are difficult to treat with poor overall response rate and overall survival. 

TGR-1202 (Umbralisib) is a highly-specific phosphoinositide-3-kinase (PI3K) delta inhibitor with nanomolar inhibitory potency, and high selectivity over the alpha, beta, and gamma isoforms. The delta isoform of PI3K is believed to be important in the proliferation and survival of B-cell lymphocytes. 

The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in previously treated non-follicular indolent non-Hodgkin’s lymphoma patients. 

  • A cycle is 28 days 
  • TGR-1202 will be self-administered: 800mg taken orally daily with food 
  • Length of time on treatment will be at least 6 months, this can vary depending on how subject responds to the treatment. 
  • Subjects will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects. 

    

Key Eligibility: 
  • Men and women age 18 and older. 
  • Histologically confirmed diagnosis of B-cell non-follicular indolent non-Hodgkin’s lymphoma, including Waldenstrom’s macroglobulinemia. 
  • Relapsed or refractory after at least one prior treatment regimen, with no limit on prior therapies. 
  • Detailed eligibility reviewed when you contact the study team. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amelyn Rodriguez, RN
(212) 746-1362
amr2017@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1806019325

ClinicalTrials.gov:

NCT03364231

Status

Not Yet Recruiting

Age Group

Adult

Sponsor