Daratumumab in paediatric and young adults with ALL/LL

• Research type

  Research Study

• Full title

  An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects ≥1 and ≤30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

• IRAS ID

  236637

• Contact name

  Darron Green

• Contact email

  dgreen38@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International N.V.

• Eudract number

  2017-003377-34

• Clinicaltrials.gov Identifier

  NCT03384654

• Duration of Study in the UK

  3 years, 0 months, 21 days

• Research summary

  Summary of research
  Lymphoblastic Leukaemia or Lymphoblastic Lymphoma (ALL/LL). ALL is a cancer of the blood and bone marrow that occurs when abnormal cells in a part of the body begin to grow out of country. LL is a rare type of non-Hodgkin lymphoma which is a cancer of the lymph nodes (glands) and other associated areas. The two conditions are often treated in very similar ways.

  Daratumumab is an anti-cancer drug, a monoclonal antibody that blocks a certain protein in the body that can help cancer cells to grow. Monoclonal antibodies are made to target and destroy only certain cells in the body. Daratumumab is approved for some other cancers, but there is no clinical experience in children. The study has 2 cohorts. Cohort 1 is B-Cell ALL/LL in second relapse or greater and Cohort 2 is T-cell ALL/LL in first relapse is designed to confirm the safety and efficacy of Daratumumab in B-cell or T-cll ALL subjects 1 – 18 years. Both cohorts will evaluate the safety and efficacy of Daratumumab in combination with standard backbone chemotherapy regimen for the cohort. There are 2 stages to the study. Stage 1 will evaluate initial safety and efficacy in each cohort within an initial 3 subjects with B-cell ALL and T-cell ALL. If there are no safety events, a further 4 subjects will enrol into cohort 1 (B-Cell ALL) and a further 5 subjects will enrol into cohort 2 (T-cell ALL).

  Summary of Results
  N/A

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  18/EE/0176

• Date of REC Opinion

  31 Jul 2018

• REC opinion

  Further Information Favourable Opinion