Effectiveness of S78454 in NHL and CLL

• Research type

  Research Study

• Full title

  Phase I/II dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in Hodgkin’s Disease, non-Hodgkin Lymphoma and Chronic Lymphocytic Leukaemia

• IRAS ID

  93633

• Contact name

  Martin Dyer

• Eudract number

  2009-013691-47

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Effectiveness of a new potential treatment for non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukaemia (CLL).The drug being studied is one of a class of drugs known as HDAC inhibitors. Previous research suggests that this type of drug can act against cancer. NHL and CLL are cancers of the lymphocytes (a type of white blood cell). The first part of this study has already been completed. The results from the first part helped us decide on the best dose and dosing schedule to test in the second part of the study. In the second part of the study we will assess how effective the drug is in the treatment of these cancers. If the study shows that the drug is effective, further studies might follow and ultimately the drug could become a new treatment that could be prescribed to NHL and CLL patients. It is important to develop new treatments because existing treatments are not effective for everybody. The study will recruit NHL and CLL patients who have relapsed or who are resistant to standard treatments. Study participants will be treated in 3 week cycles (14 days of study treatment followed by 7 days without treatment). Each participant will have a minimum of 2 cycles of treatment but could have more depending on their progress. There is no maximum number of cycles. This is a single-arm, open label study meaning that all participants will take the drug, which is not being compared with any other drug during the study. Participants will undergo various procedures during the study including: pregnancy test for women; physical examination; measurement of temperature, blood pressure, heart rate; blood tests, urine sample, electrocardiogram, bone marrow sample, scans and tumour cell sample. The study, which is funded by a pharmaceutical company, will take place at Leicester Royal Infirmary.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  12/EM/0051

• Date of REC Opinion

  29 Feb 2012

• REC opinion

  Further Information Favourable Opinion