Loncastuximab Tesirine with Rituximab vs. Immunochemotherapy in Relapsed/ Refractory DLBCL (LOTIS5)

• Research type

  Research Study

• Full title

  A Phase 3 Randomized Study of Loncastuximab Tesirine Combined with Rituximab Versus Immunochemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)

• IRAS ID

  1003647

• Contact name

  Sabine Soldan

• Sponsor organisation

  ADC Therapeutics SA

• Eudract number

  2020-000241-14

• Clinicaltrials.gov Identifier

  NCT04384484

• Research summary

  This research study is designed to evaluate the effect of Loncastuximab Tesirine Combined with Rituximab Versus Immunochemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL). Male and female participants aged 18 years of age and older with Relapsed or Refractory DLBCL, a type of non-Hodgkin lymphoma (NHL) will participate. The entire study will enrol approximately 350 participants in about 125 research sites. Part 1, will enrol 20 participants. Part 2 will enrol 330 participants .

  This study will be conducted in two parts. :
  - Part 1 of the study will test if the investigational medication called loncastuximab tesirine in combination with rituximab is a safe and effective treatment for DLBCL.
  - Part 2 will compare the combination of loncastuximab tesirine with rituximab (Lonca-R) to a standard treatment regimen for DLBCL: rituximab plus gemcitabine and oxaliplatin (R-GemOx). Part 2 is to evaluate whether Lonca-R is more effective than R-GemOx in decreasing the growth and spread of lymphoma, preventing it from coming back quickly and helping patients live longer.

  Both parts include a Screening Period (up to 28 days), a Treatment Period (approximately 16 or 24 weeks for Part 1 depending on your treatment group or approximately 24 weeks for Part 2), and a Follow-Up Period (up to 4 years after the last dose of study medications). The total amount of time participants’ are in the study will depend on how they tolerate the study medication and if their cancer responds well to the treatment.

  During the study participants’ will undergo a range of different procedures including physical examinations, radiological exams, blood sampling etc.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  21/NW/0133

• Date of REC Opinion

  8 Jul 2021

• REC opinion

  Further Information Favourable Opinion