JCAR017 in Adults with DLBCL,Phase 3, Transform Study

• Research type

  Research Study

• Full title

  A global randomized multicenter phase 3 trial to compare the efficacy and safety of JCAR017 to standard of care in adult subjects with high-risk, transplant-eligible relapsed or refractory aggressive B-cell non Hodgkin lymphomas (TRANSFORM)

• IRAS ID

  246037

• Contact name

  Claire Roddie

• Contact email

  c.roddie@ucl.ac.uk

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2018-000929-32

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  This is a phase 3 study for patients with aggressive B-cell Non-Hodgkin Lymphoma (NHL). JCAR017 is an experimental therapy being developed for the treatment of B-cell NHL. The purpose of this study is to compare the current standard of care (SOC) treatment with JCAR017 to determine whether JCAR017 can give better outcomes in treating B-cell NHL. The study is global, randomised, and open-label (patients know the type of treatment they are receiving).

  The study is split into three periods - screening (to check for eligibility), treatment and follow up. During screening all patients will undergo procedure called leukapheresis to collect some of their immune cells which could be used to make JCAR017 T cells. All eligible patients will be randomised into 2 treatment arms - Arm A (SOC) or Arm B (JCAR017).
  Patients in Arm A will receive up to 3 cycles of SOC chemotherapy. If their disease gets worse or if the response to SOC treatment is insufficient, they may be allowed to ‘crossover’ to Arm B and receive JCAR017 treatment.
  Patients in Arm B will receive lymphodepleting chemotherapy followed by infusion of the JCAR017 T cells. If required, patients will receive standard chemotherapy during the time it takes to manufacture the JCAR017 cells. After the single infusion of JCAR017 patients will be closely monitored for at least 4 weeks. Patients will then enter a post treatment period of approximately 3 years.

  The study will take place at 2 NHS hospital sites in the UK and 9 patients are expected to be recruited. A total of 182 patients will take part worldwide.

  Tests undertaken will include but are not limited to; physical exam, vital signs, height, weight, pregnancy test, MRI, PET, electrocardiogram, blood tests, tumour biopsies, questionnaires.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  18/LO/1383

• Date of REC Opinion

  5 Dec 2018

• REC opinion

  Further Information Favourable Opinion