Trial Name

WT1 Immunity via DNA fusion Gene Vaccination in Haematological Malignancies by intramuscular injection followed by intramuscular electroporation.

Description

The WIN trisl studys the effect of DNA vaccination with two DNA vaccines, p.DOM-WT1-37 and p.DOM-WT1 in two patient groups Chronic Myeloid Leukaemia (CML) and?Acute Myeloid Leukaemia (AML).

Objectives

Primary Objectives:

• CML: Molecular response of BCR-ABL;
• AML: Time to disease progression.

Secondary Objectives:

• 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

Design

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. HLA A2 ¨Cve patients will be followed up on trial without vaccination.

Status

Complete

Population

• Vaccination Arm: (HLA A2+ve patients): 32 patients with data to at least 8 weeks will be recruited into the CML treatment group. 39 patients with data to at least 8 weeks will be recruited into the AML treatment group.
• Control Arm: this arm will consist of all eligible and consenting patients who are HLA A2 ¨Cve.

Contact Details

All Trial enquiries should be addressed to ctu@soton.ac.uk