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WT1 Immunity Via DNA Fusion Gene Vaccination in Haematological Malignancies by Intramuscular Injection Followed by Intramuscular Electroporation

NCT01334060 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-09-07

No results posted yet for this study

Summary

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

Conditions

  • Leukaemia (Acute)
  • Leukaemia (Chronic)
  • Leukaemia (Acute Myeloid)
  • Leukaemia (Acute Lymphoblastic)
  • Leukaemia (Acute Promyelocytic)

Interventions

BIOLOGICAL

p.DOM-WT1-37 DNA Vaccine and p.DOM-WT1-126 DNA Vaccine

p.DOM-WT1-37: 1mg/dose/vaccine p.DOM-WT1-126: 1mg/dose/vaccine The DNA vaccine will be administered 6 times at 4 weekly intervals. Responders (Immunological but without molecular progression) may continue vaccination 3 monthly to maximum of 24 months. The vaccines will be injected intramuscularly (im) followed by electroporation (EP) into separate locations.

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Royal Devon and Exeter NHS Foundation Trust

    collaborator OTHER

  • Inovio Pharmaceuticals

    collaborator INDUSTRY

  • Efficacy and Mechanism Evaluation (EME) Programme

    collaborator OTHER

  • Leukemia Research Fund

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-01
Primary Completion
2013-02-28
Completion
2013-02-26

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01334060 on ClinicalTrials.gov