Trials / Completed
CompletedNCT01334060
WT1 Immunity Via DNA Fusion Gene Vaccination in Haematological Malignancies by Intramuscular Injection Followed by Intramuscular Electroporation
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- University Hospital Southampton NHS Foundation Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2013-02-01
- Completion
- 2013-02-26
- First posted
- 2011-04-12
- Last updated
- 2018-09-07
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01334060. Inclusion in this directory is not an endorsement.