A Phase 2b Ublituximab, TGR-1202, Bendamustine in NHL patients

• Research type

  Research Study

• Full title

  A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 with or without Bendamustine and TGR-1202 alone in Patients with Previously Treated Non-Hodgkin’s Lymphoma.

• IRAS ID

  226881

• Contact name

  Robert Niecestro

• Contact email

  rn@tgtxinc.com

• Sponsor organisation

  TG Therapeutics, Inc

• Eudract number

  2016-004718-90

• Duration of Study in the UK

  4 years, 5 months, 1 days

• Research summary

  The purpose of this multicenter, Phase 2b Randomized, 3 arm study is evaluate the efficacy and safety of study drugs, TGR-1202 both alone and in combination with Ublituximab with or without bendamustine in the treatment of previously-treated Non-Hodgkin’s Lymphoma (NHL).
  Approximately 850 patients (30 patients in UK) with non-Hodgkin’s lymphoma (DLBCL (Diffuse large B-cell lymphoma) , SLL (Small lymphocytic lymphoma), FL (follicular lymphoma), MZL (marginal zone lymphoma) will be enrolled. The total estimate duration of the study is five years.

  Despite an array of available therapies, indolent NHL remains an incurable disease. Not all patients respond to recently approved novel agents and intolerability issues persist, necessitating new treatment options for relapsing and refractory patients. DLBCL patients with relapsed/refractory disease or those patients who are unsuitable for high-dose therapy (HDT) and autologous stem cell transplant (ASCT) due to toxicities from previous treatments, age, comorbidities, or poor functional status have a poor prognosis. It is estimated that approximately one-third of patients with DLBCL will develop relapsed/refractory disease, representing an unmet medical need.

  The Study drugs:
  Ublituximab is a glycoengineered monoclonal antibody that induces an immune response resulting in the lysis of B cells.
  TGR-1202 is a highly-specific, orally available phosphoinositide-3-kinase (PI3K) delta (δ) inhibitor with nanomolar inhibitory potency.
  Given the non-overlapping mechanisms of action of each of these agents, the combination of ublituximab and TGR1202 was explored in a Phase I/Ib study in patients with previously treated hematologic malignancies (Lunning ASH 2014). The combination regimen is shown to be well tolerated with clinical activity noted in a variety of hematologic malignancies, with responses reported in patients with a broad range of non-Hodgkin’s lymphomas.

  Bendamustine hydrochloride is marketed alkylating antitumour agent used in treatment of NHL.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  17/LO/1289

• Date of REC Opinion

  29 Sep 2017

• REC opinion

  Further Information Favourable Opinion