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AzTrials

Leukaemia (Acute)Phase 2WINNCT01334060

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

A Phase 2 study testing p.DOM-WT1-37 DNA Vaccine and p.DOM-WT1-126 DNA Vaccine in people with Leukaemia (Acute) and Leukaemia (Chronic), run by University Hospital Southampton NHS Foundation Trust at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
p.DOM-WT1-37 DNA Vaccine and p.DOM-WT1-126 DNA Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
3 sitesUnited Kingdom
Study dates
1 Feb 2011to 26 Feb 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • HB>100 g/l
  • 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 afterwards.

Who cannot join

  • CML patients:
  • CML in accelerated phase or blast crisis or having achieved CMR at any point during imatinib therapy.
  • Imatinib dose modification in the previous year, Imatinib interruption for more than 15 days in the previous 6 months to enrolment
  • Prior interferon-α therapy
  • hypocellular bone marrow (<20%)
  • Complete molecular response (CMR)
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  • AML patients:
  • AML in haematological relapse or eligible for allogeneic SCT.
  • hypocellular bone marrow (<20%)
  • 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 leukaemia 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.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, EX2 5DW

  • Imperial College NHS Trust

    London, W12 0HS

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD

Other trials in United Kingdom

About this study

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

Being tested
p.DOM-WT1-37 DNA Vaccine and p.DOM-WT1-126 DNA Vaccine
Medical subject headings
Leukemia, Bronchiolitis Obliterans Syndrome, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT01334060
Study groupRoleWhat they receive
CML HLA A2-No interventionNot described
AML HLA A2-No interventionNot described
AML HLA A2+ExperimentalNot described
Receives: Biological: p.DOM-WT1-37 DNA Vaccine and p.DOM-WT1-126 DNA Vaccine
CML HLA A2+ExperimentalNot described
Receives: Biological: p.DOM-WT1-37 DNA Vaccine and p.DOM-WT1-126 DNA Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Molecular response following p.DOM-epitope DNA vaccination in patients with CML (BCR-ABL, WT1) and AML (WT1)

    Measured: 2 years

Secondary outcomes (2)

  1. CML-Time to disease progression, next treatment and survival

    Measured: 2 years

  2. AML-2 year survival, overall survival

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2011 (estimated)
  2. Study start1 Feb 2011
  3. Primary completionFeb 2013
  4. Study completion26 Feb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01334060
Sponsor's protocol ID
RHMCAN0700
Other IDs
2009-017340-14, ISRCTN62678383, 2009
Acronym
WIN
Status last verified
Sep 2018
First submitted
11 Apr 2011
Last updated
7 Sep 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Chaise C, Buchan SL, Rice J, Marquet J, Rouard H, Kuentz M, Vittes GE, Molinier-Frenkel V, Farcet JP, Stauss HJ, Delfau-Larue MH, Stevenson FK. DNA vaccination induces WT1-specific T-cell responses with potential clinical relevance. Blood. 2008 Oct 1;112(7):2956-64. doi: 10.1182/blood-2008-02-137695. Epub 2008 May 23.

    PubMed 18502835

  • Rice J, Ottensmeier CH, Stevenson FK. DNA vaccines: precision tools for activating effective immunity against cancer. Nat Rev Cancer. 2008 Feb;8(2):108-20. doi: 10.1038/nrc2326.

    PubMed 18219306

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing p.DOM-WT1-37 DNA Vaccine and p.DOM-WT1-126 DNA Vaccine in people with Leukaemia (Acute) and Leukaemia (Chronic), run by University Hospital Southampton NHS Foundation Trust at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Molecular response following p.DOM-epitope DNA vaccination in patients with CML (BCR-ABL, WT1) and AML (WT1) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01334060, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.

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