Study to determine the PK/PD of Forodesine in children with ALL & NHL

• Research type

  Research Study

• Full title

  A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non-Hodgkin’s Lymphoma

• IRAS ID

  6440

• Sponsor organisation

  Mundipharma Research Limited

• Eudract number

  2008−002219−42

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study is to evaluatepharmacokinetic and pharmacodynamic parameters of intravenous and oralforodesine, an experimental medicine. Safety and efficacy will also beassessed. Twenty eight patients(aged between 2 to 18 years old) with relapsedor refractory T-cell or B-cell Acute Lymphoblastic Leukaemia or T-cellNon-Hodgkinds Lymphoma will take part in approximately 15 hospitals in Europe.patients will participate for several weeks or months depending on how theyrespond to the treatment. In the Screening Phase various tests will beperformed to ensure that the patient is eligible to join the study. This phasecan last from one day to one week. In the Treatment Phase of the study patientsill receive forodesine, by intravenous infusion for the first 5 days. Aftertwo days without treatment patients will then receive the drug orally for up to31 days. Blood tests will be taken during this period to assess how the drugbehaves in the body. If at the end of the Treatment Phase it is found thatforodesine is making the cancer respond, reduce or become stable then thepatient may be advised by their doctor to continue taking forodesine for up tosix months. This is called the Extension Phase of the study. If this is thecase then the doctor will see the patient at least once a month to check thatthe medicine is continuing to have an effect. During these monthly visits thedoctor will ask some questions on how the patient is feeling and some testswill be performed. The tests that are performed are necessary to check how thepatient is responding to forodesine treatment. It is not certain patients willhave a clinical benefit by taking part in this study, but there may betherapeutic potential based on previous efficacy studies, however these studieswere performed in adults and young adults.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  08/H0305/61

• Date of REC Opinion

  8 Oct 2008

• REC opinion

  Favourable Opinion