Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Conditions
Brief summary
The study will be an open label, single arm, phase I study intended to identify the safety and tolerability of AML Cell Vaccine given to eligible MDS RAEB-2 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.
Interventions
BIOLOGICALAML Cell Vaccine
Sponsors
King's College Hospital NHS Trust
King's College London
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of MDS RAEB-2 or primary (de novo) or secondary AML defined according to the WHO classification either as a new diagnosis or as a relapse. * 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). Key
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency, severity of adverse events to the AML cell vaccine | 52 weeks |
| Vaccine-related toxicity based on the NCI criteria V4.0 | 52 weeks |
Outcome results
None listed