Leukaemia (Acute Lymphoblastic) Clinical Trial
Official title:
WT1 Immunity Via DNA Fusion Gene Vaccination in Haematological Malignancies by Intramuscular Injection Followed by Intramuscular Electroporation
The study is not currently recruiting new subjects due to an interruption in funding from its
sponsors. Efforts are under way to re-establish funding, however, the study is currently
on-hold pending the outcome of these re-funding efforts. There have been no safety concerns
identified during the study
This is an open label, single dose level, phase II study in two patient groups (CML and AML)
using genetic randomisation. Consented and eligible HLA A2+ve patients will be vaccinated
with two DNA vaccines and HLA A2 -ve patients will be followed up with molecular monitoring
only. The objectives are to evaluate: 1) Molecular response following p.DOM-epitope DNA
vaccination in patients with CML (BCR-ABL, WT1) and AML (WT1) at weeks 4, 8, 12, 16, 20 and
at months 6, 12, 18 and 24. 2) Time to disease progression, 2 year survival rate (patients
with AML) 3) Correlation of molecular responses with immunological responses. Primary
Objective: CML: Molecular response of BCR-ABL. AML: Time to disease progression. Secondary
Objective: Molecular response of WT1 transcript levels, immune responses to WT1 and DOM,
Toxicity, CML-Time to disease progression, next treatment and survival, AML-2 year survival,
overall survival
n/a