Effects of Ceplene® & IL-2, Proleukin® in Patients with AML in CR1

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter Study of the Effects of Remission Maintenance Therapy with Ceplene® (Histamine Dihydrochloride), Given in Conjunction with Low-Dose Interleukin-2 (IL-2, Proleukin®), on Immune Response and Minimal Residual Disease (MRD) in Adult Patients with Acute Myeloid Leukemia (AML) in First Complete Remission (CR1)

• IRAS ID

  22853

• Eudract number

  2009-012083-14

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Acute myeloid leukaemia (AML) is a rare disease, which account for less than 3% of all cancers. Among adults, AML is the most common type of acute leukaemia and has one of the lowest long-term survival rates.Complete remission (CR) is usually achieved after induction chemotherapy in 50-60% of patients across all age groups. Remission means that the disease has responded fully to treatment. Despite ensuing consolidation chemotherapy, most AML patients will relapse (deteriorate) within 3 years. Relapse after achieving CR remains a major clinical challenge, therefore, once remission has been achieved, a critical goal in AML therapy is to prevent or delay relapse by maintaining patients in CR.In a previous trial with Ceplene/IL-2 no treatment-related deaths or long-term significant sequelae were associated with Ceplene/IL-2. Commonly reported AEs after treatment with Ceplene/IL-2 werefluhing, various injection site reactions, headache, fatigue, pyrexia, and nausea.To be eligible to take part in this trial amongst other factors patients must have a bone marrow examination confirming CR and must be over the age of 18.It is estimated that 150 patients will be enrolled and enrolment will be completed in approximately 2 years. Ceplene/IL-2 treatment will be continued for up to ten 3-week cycles over a period of approximately 18 months. IL-2 will be administered subcutaneously (sc) (just below the skin), twice daily during treatment periods. Ceplene will be administered sc twice daily after IL-2. After the patient or family member is trained by study staff and demonstrates the ability to administer injections, both drugs may be administered at home.After completion of the treatment, patients will be monitored for a minimum of 6 months to determine the duration of Leukaemia free survival at 2 years.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  09/H1211/79

• Date of REC Opinion

  7 Sep 2009

• REC opinion

  Favourable Opinion