ORACLE
Research type
Research Study
Full title
Randomized Phase 3 Study evaluating the Efficacy and the Safety of Oral Azacitidine (CC-486) compared to Investigator’s Choice Therapy in Patient with Relapsed or Refractory Angioimmunoblastic T cell Lymphoma
IRAS ID
260653
Contact name
Christopher Fox
Contact email
Sponsor organisation
LYSARC: THE LYMPHOMA ACADEMIC RESEARCH ORGANISATION
Eudract number
2017-003909-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
The ORACLE trial will compare the efficacy and safety of oral azacitidine with gemcitabine and bendamustine (given as intravenous infusions) in patients with relapsed or refractory angioimmunoblastic T cell Lymphoma (AITL) - a rare and aggressive type of non-Hodgkin lymphoma that grows quickly.
Participants will be randomised 1:1 between oral azacitidine or the Investigator’s Choice Therapy (ICT) of bendamustine or gemcitabine – both of which are chemotherapies that are used to treat AITL in the UK.
The aim of this research is to find out if oral azacitidine gives AITL participants a better response, fewer side effects, and longer survival times than the current treatments that are used. This will inform doctors about what treatments to use for treating patients with this cancer in the future.
ORACLE is running in France, Belgium, Italy, UK, Denmark, Austria, Korea and Japan. Seven AITL patients will be recruited and treated across five specialist haemato-oncology centres in the UK.
Participants who enter the study will be closely monitored for evidence of response and side effects and will undergo assessments including lymph node biopsies, bone marrow biopsies, blood samples, and PET-CT and CT scans.
During treatment with oral azacitidine patients will be seen on day 1 of each cycle and will then take the drug at home for 14/28 days. Treatment continues until the patient stops through their own choice, because of side effects, or because their cancer gets worse. Treatment with gemcitabine and bendamustine takes place in the hospital for 6 cycles on 3/28 and 2/21 days respectively. Patients continue to be seen weekly for the first 24 weeks, 12-weekly during years 1 and 2, and every 24 weeks during year 3.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
19/EM/0341
Date of REC Opinion
6 Jan 2020
REC opinion
Further Information Favourable Opinion