B7.1/IL-2 Leukaemia Cell Vaccine for Non-Transplant AML RFUSIN2-AML2 (NTX)

King's College London

Status and phase

Unknown

Phase 1

Conditions

Leukemia, Myeloid, Acute

Myelodysplastic Syndromes

Treatments

Biological: AML Cell Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT02493829

2494

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.