- SUB-TYPE OF MDS: High Risk MDS RAEB-2 and Acute Myeloid Leukaemia Patients Unsuitable for Allogeneic Haematological Stem Cell Transplant
- SEVERITY OF MDS: High Risk MDS
- NAME OF DRUG: B7.1 (CD80)/IL-2 Immune Gene Therapy
- Aims and benefits: This is a phase I study intended to identify the safety and tolerability of an "AML Cell Vaccine" given to eligible MDS and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction chemotherapy.
- Primary outcome measures:
To determine the toxicity of the vaccine and the frequency and severity of adverse events.
- Main basic inclusion criteria:
- Diagnosis of MDS RAEB-2 or primary (de novo) or secondary AML.
- Patients for whom the optimal therapy in CR1 would be to undergo allogeneic bone marrow transplantation, but for whom this procedure is either not recommended (e.g. due to comorbidities) or not available (e.g. lack of a suitable donor
- Main basic exclusion criteria:
- Patients with MDS RAEB-2 or AML and favourable prognostic profile (good risk cytogenetics: t(15;17)(q22;q12~21), inv16(p13q22)/t(16;16)(p13;q22), t(8;21)(q22;q22) or cytogenetically normal AML with NPM1 mutation and absence of Flt-3 ITD).
- Patients unsuitable for standard induction chemotherapy.
- Patients who have previously undergone or will be able to undergo allogeneic transplantation.
- Patients who have had previous or current treatment with any form of investigational immunotherapy.
- Trial sites/locations and name of physician in charge of trial:
- Sponsor and collaborator - King's College Hospital NHS Trust, London
Please read information and always discuss trial information with your own physician.