WT1 Immunity via DNA fusion Gene Vaccination in Haematological Malignancies by intramuscular injection followed by intramuscular electroporation. - WIN: Anti-WT1 DNA fusion gene vaccine in haematological malignancies

Phase 1

• Conditions: Chronic myeloid Leukemia and acute myeloid leukemia in cytogentic remission

• Registration Number: EUCTR2009-017340-14-GB
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-17
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 184

Inclusion Criteria

CML patients:

Philadelphia chromosome positive CML in chronic phase, in complete cytogenetic
response (CCyR) but with detectable BCR-ABL transcripts and maintained the CCyR on
imatinib monotherapy for a minimum of 24 months.

AML patients:

WT1+ AML in CR or morphologic CR with incomplete blood count recovery (CRi);

All patients:

• = 18 years of age, written informed consent.
• Performance status of 0 or 1.
• For vaccination groups: HLA-A0201 positive in at least one allele.
• For control groups: HLA A2 negative in both alleles.
• Renal function and liver function (Creatinine <1.5 x upper limit of normal, liver
function tests < 1.5 x upper limit of normal); Lymphocyte count > 1.0 x109/l; normal
clotting.
• Adequate venous access for repeated blood sampling according to protocol
schedule.
• If sexually active and possibly fertile, patients must agree to use appropriate
contraceptive methods during the trial and for six months afterward.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with CML:

• CML in accelerated phase or blast crisis.
• Imatinib dose modification in the previous year, imatinib interruption for more than 15 days in the previous 6 months to enrollment.
• Prior interferon-a therapy.
• having achieved complete molecular response (CMR) at any point during imatinib therapy.
• hypocellular bone marrow (<20%).

Patients with AML:

• AML in haematological relapse or eligible for allogeneic SCT.
• AML patients with the good-risk abnormalities comprised by the core binding
factor leukaemias (i.e., AML with the translocation (8;21) and inversion of
chromosome 16, and acute promyelocytic leukemia with the translocation (15;17)).

All patients:

• Systemic steroids or other drugs with a likely effect on immune competence are
forbidden during the trial. The predictable need of their use will preclude the patient from trial entry.
• Major surgery in the preceding three to four weeks from which the patient has not
yet recovered.
• Patients who are of high medical risk because of non-malignant systemic disease,
as well as those with active uncontrolled infection.
• Patients with any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial, such as concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease.
• Current malignancies at other sites, with the exception of adequately treated basal
or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease
for five years and are deemed at low risk for recurrence, are eligible for the study.
• Patients who are serologically positive for or are known to suffer from Hepatitis B, C, Syphilis or HIV. Counselling will be offered to all patients prior to testing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified