Date: 2013-07-26
Type of information: Completion of patient enrollment
phase: 2
Announcement: completion of patient enrollment
Company: Cell Medica (UK)
Product: Adoptive cellular therapy
Action mechanism:
Disease: pre-emptive treatment of cytomegalovirus (CMV) infections in patients who have received a bone marrow transplant from an unrelated donor
Therapeutic area: Infectious diseases - Transplantation
Country: UK
Trial
details: The CMV~ACE/ASPECT trial is a randomised, controlled study and will include 36 patients across ten UK hospitals. Patients in the trial’s treatment arm will receive CMV-specific memory T cells while patients in the control arm will receive only conventional antiviral treatment. The Chief Investigator is Dr. Karl Peggs at the UCL Cancer Institute. The study is expected to be completed by the end of 2012 with results published in 2013. the CMV~ACE/ASPECT study is being carried out at the following hospitals in the UK, subject to final local approvals: University College London Hospital, Queen Elizabeth Hospital, Birmingham, University Hospitals Bristol, King’s College Hospital, Manchester Royal Infirmary, The Christie Hospital Manchester, Nottingham City Hospital, Churchill Hospital Oxford, St James’s Institute of Oncology, Leeds, and The Royal Free Hospital.The trial will complement an ongoing confirmatory (Phase III) study, CMV~IMPACT, which is investigating the use of adoptive cell therapy in bone marrow patients whose donors are siblings. The CMV~IMPACT Study is also sponsored by Cell Medica and funded through a Translation Award from The Wellcome Trust.
Latest
news: * On July 26, 2013, Cell Medica announced the completion of recruitment in the CMV~ACE/ASPECT study, a randomized stage Phase II clinical study investigating Cytovir™ CMV. The CMV~ACE/ASPECT study is a phase II randomized study to investigate the use of adoptive cellular therapy (ACT) in combination with conventional antiviral therapy for the treatment of CMV reactivation episodes in patients following allogeneic hematopoietic stem cell transplant from an unrelated donor. The study recruited over 33 months in 9 centers across the UK. Results will be available January 2014 after the 6 months follow-up period of the patients. The principal investigator of the study is Dr. Karl Peggs, Reader in Stem Cell Transplantation and Immunotherapy at UCL Cancer Institute and Honorary Consultant in Haematology & Transplantation at UCLH NHS Hospitals Foundation Trust. The CMV~ACE/ASPECT study represents a collaboration between Leukaemia & Lymphoma Research, a UK charity dedicated to research into blood cancers including leukemia, lymphoma and myeloma, University of Birmingham, and UCL (University College London). * On February 10, 2011, Cell Medica has announced that the first patient has been treated in the CMV~ACE/ASPECT trial at University College Hospital London. The Phase II randomised clinical trial is designed to demonstrate the efficacy of adoptive cellular therapy for the pre-emptive treatment of cytomegalovirus (CMV) infections in patients who have received a bone marrow transplant from an unrelated donor.
