- SUB-TYPE OF MDS:Patients with primary or secondary AML acute myeloid leukaemia (including disease
transformed from Myelodysplastic Syndrome) who fail to enter complete morphological remission or have persistence of cytogenetic abnormality following intensive combination chemotherapy at day+100 post-transplant
- SEVERITY OF MDS: AML
- NAME OF DRUG: Lentivirus Transduced Acute Myeloid Leukaemic Cells (AML) that express
B7.1 (CD80) and IL-2 (AML cell vaccine)
- Aims and benefits: This is a phase 1 study aimed at determining the safety of the AML cell vaccine.
- Basic inclusion criteria:
- ≥ 18 years of age
- Prior treatment with Myeloablative or Reduced Intensity Conditioned allogeneic HSCT
- Morphological relapse of disease as defined by the presence of >5% bone marrow blasts post allogeneic HSCT
- Presence of ≥25% donor CD3 chimerism at time of disease relapse
- Patients need to have achieved morphological remission (as defined by <5% blast in the bone marrow) following cytoreductive chemotherapy, for treatment of disease relapse.
- HIV negative at relapse.
- Absence of active viral infections including HTLV-1, hepatitis B or C.
- Adequate renal and liver function
- ECOG performance status of 0, 1 or 2
- Basic exclusion criteria:
- Life expectancy of <24 weeks
- Patients not fit for cytoreductive chemotherapy following relapse
- Evidence of graft versus host disease
- Concurrent use of other forms of anti-leukaemic therapy for relapse
- Other malignancy with the exception of carcinoma in situ.
- Significant history of heart disease (unstable angina, myocardial infarction within the past six months)
- Positive pregnancy test
- Trial sites/locations and name of physician in charge of trial (none are currently recruiting):
- Kings College Hospital
Please read information and always discuss trial information with your own physician.