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    Summary
    EudraCT Number:2011-004144-22
    Sponsor's Protocol Code Number:BORLEUWT01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-004144-22
    A.3Full title of the trial
    A Phase I/II study to assess the safety and immunogenicity of WT1-A10 + AS01B Antigen-Specific Cancer Immunotherapeutic (ASCI) combined with infusions of ex vivo regulatory T cells depleted T lymphocytes in in vivo regulatory T cells depleted patients as post-consolidation therapy for adult patients with WT1-positive Acute Myeloid Leukemia (AML) in CR1 (for high risk patients) or in CR2 or CR3 who are not eligible for allogeneic stem cell transplantation (SCT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety and immunogenicity of an anti leukemia Antigen-Specific Cancer Immunotherapeutic (ASCI) combined with infusions of T lymphocytes in in vivo regulatory T cells depleted patients as post-consolidation therapy for adult patients with WT1-positive Acute Myeloid Leukemia (AML).
    A.4.1Sponsor's protocol code numberBORLEUWT01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstitut Jules Bordet - Université Libre de Bruxelles
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFonds National de la Recherche Scientifique (FNRS)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut Jules Bordet
    B.5.2Functional name of contact pointPhilippe Lewalle
    B.5.3 Address:
    B.5.3.1Street AddressRue Héger-Bordet 1
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3225417208
    B.5.5Fax number3225413453
    B.5.6E-mailphilippe.lewalle@bordet.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameWT1-A10 + AS01B
    D.3.2Product code WT1-A10 + AS01B
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNWT1-A10
    D.3.9.3Other descriptive nameWT1-A10
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    For adult patients with WT1-positive Acute Myeloid Leukemia (AML) in CR1 (for high risk patients) or in CR2 or CR3 who are not eligible for allogeneic stem cell transplantation (SCT)
    E.1.1.1Medical condition in easily understood language
    Protein and adjuvant injection for consolidation immunotherapy in leukemia in order to improve outcome
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Co-primary Objectives :
    To evaluate the safety of combined treatment strategy of WT1-A10 + AS01B, infusions of ex vivo regulatory T cells depleted T lymphocytes and in vivo regulatory T cells depletion as post-consolidation therapy.
    To evaluate the safety of Treg depletion (including auto-immunity).
    E.2.2Secondary objectives of the trial
    To evaluate the immune (humoral and cellular) response induced by WT1-A10 + AS01B in AML patients, in vivo depleted in Tregs by metronomic doses of cyclophosphamide, administered concomitantly with Tregs-depleted T cells add-back.
    To evaluate the clinical activity of this approach in bad risk patients in CR1 and all patients in CR2 or CR3, non eligible for an allo-HSCT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following criteria are to be checked at the time of study entry. Patients may only be included in the study if all of the following criteria are met:
    1. The patient has cytologically proven AML, as defined by the WHO classification. The leukemia is a de novo or a secondary leukemia.
    2. The patient received the following therapy according to the institution’s standard of care:
    •For patients ≤ 60 years old, at least two cycles of intensive chemotherapy (induction and consolidation)
    •For patients > 60 years old, at least one induction chemotherapy. Any patients with severe co-morbidity for which consolidation is unacceptable, can receive only one induction therapy.
    3. The patient is in complete morphologic remission, as detailed in Appendix G
    a)AML patients in first complete remission (CR1) who are not eligible for allo-HSCT following the institution’s standard of care, except the favourable genetic group subset as defined in Table 1 below which is excluded from this study.
    According to the EBMT treatment consensus: favourable risk group AML patients should not be transplanted upfront, whilst high and intermediate-II risk group patients should be transplanted as first treatment option (The EBMT handbook 5th edition, 2008). The benefit of transplant for the intermediate group-I is still an open question and a center decision.
    b)All AML patients in second or third complete morphological remission (CR2 or CR3) according to response criteria who are not eligible for allo-SCT.
    4. The patient's blasts cells show over-expression of WT1 transcripts, detected in peripheral blood by qRT-PCR at diagnosis or in first relapse.
    Note: WT1 expression analysis will be done using peripheral blood obtained before chemotherapy.
    5. Written informed consent has been obtained prior to the performance of any protocol-specific procedure.
    6. The patient is ≥ 18 years of age at the time of signing of the ICF.
    7. ECOG performance status of 0, 1, or 2 at the time of enrolment.
    8. Adequate hepatic and renal function defined as:
    - Serum bilirubin < 1.5 times the Upper Limit of Normal (ULN).
    - Serum alanine aminotransferase ALAT < 2.5 times the ULN.
    - Calculated creatinine clearance > 40 mL/min.
    9. If the patient is female, then she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to treatment administration, have a negative pregnancy test, and continue such precautions for two months after completion of the treatment administration series.
    10. Under the investigator criteria, the patient is able to comply with the protocol requirements during the duration of the study.
    11. In the investigator's opinion and in compliance with the Institution hematology guidance, the patient should not be eligible for an approved standard of care such as induction with chemotherapy or allo-HSCT.

    E.4Principal exclusion criteria
    The following criteria should be checked at the time of study entry. If any are met, then the patient must not be included in the study:
    1. The patient is in morphologic leukemia-free state or in morphologic complete remission but with incomplete blood count recovery as defined by IWG Response Criteria (Appendix G)
    2. The patient is in CR1 and is in the category of low-risk for relapse patients, i.e. belong to the favourable genetic group subset (as described in table 1).
    3. The patient was diagnosed with leukemic central nervous system (CNS) disease (E.g. before chemotherapy) or presents neurological symptoms at baseline suggestive of a CNS involvement.
    4. The patient has received, is receiving (or is due to receive) allogeneic HSCT.
    5. The patient has concomitant malignancies, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
    6. The patient is known to be human immunodeficiency virus positive.
    7. The patient has autoimmune disease such as, but not limited to, multiple sclerosis, lupus, rheumatoid arthritis and inflammatory bowel disease.
    8. The patient has a history of allergic reactions likely to be exacerbated by any component of the study investigational product.
    9. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
    10. The patient has congestive heart failure, symptomatic coronary artery disease, or previous myocardial infarction.
    11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
    12. The patient has received any investigational or non-registered medicinal product other than the study medication within 30 days preceding the first dose of study medication, or plans to receive such a drug during the study period.
    13. The patient requires concomitant treatment with systemic corticosteroids or any immunosuppressive agents. The use of inhaled corticosteroids or topical steroids is permitted.
    14. The patient has an active infection and/or is receiving antibiotics. Enrolment will be allowed 48h00 after the end of the treatment.
    15. For female patients: the patient is pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    The two co-primary endpoints of this study are:
    •Occurrence of severe toxicities during the study treatment phase related or possibly related to ASCI, to Treg depletion or to the combination of both and defined as:
    -An ASCI-related or possibly ASCI-related Grade 4 toxicity (exception: ASCI-related or possibly ASCI related Grade 4 fatigue including lethargy, asthenia and malaise must have a duration of at least 48 hours to be taken into account).
    -An ASCI-related toxicity or possibly ASCI-related Grade 3 toxicity lasting for at least 48 hours, (exceptions: myalgia, arthralgia, headache and fever, regardless of duration).
    -An allergic reaction/hypersensitivity Grade 2 toxicity (i.e. rash, flushing, urticaria and dyspnea). Drug fever will not be part of this definition.
    -An ASCI-related or possibly ASCI-related decrease in renal function, with a calculated creatinine clearance < 40 ml/min.
    -An ASCI-related or possibly ASCI-related Grade 2 cardiac ischemia/infarction (i.e. asymptomatic and testing suggesting ischemia; stable angina).
    -A Treg depletion-related or possibly related Grade 2 toxicity. (i.e. potential immune-related diseases (pIMDs))
    E.5.1.1Timepoint(s) of evaluation of this end point
    - first patient : December 2011
    - interim analysis : November 2012
    - last patient : November 2013.
    - last patient follow-up : November 2015
    E.5.2Secondary end point(s)
    • Immunogenicity endpoints:
    -The anti-WT1 humoral response.
    -The anti-WT1 cellular (T-cell) response.
    -Blood Treg level during and after completion of the study compared to Treg at pre-treatment.

    Immunogenicity of the WT1-A10 + AS01B ASCI will be described at different time points.
    • Safety endpoints:
    -Occurrence of adverse events and serious adverse events during the study treatment period and ending 30 days after the last study treatment administration, including abnormal hematological and biochemical parameters.
    -Occurrence of serious adverse events related to study treatment during the whole study duration.
    • Clinical activity endpoints:
    -Time to study treatment failure; defined as withdrawal from investigational product because of disease progression or death. Persistence of Complete Response (CR), or stabilisation of minor recurring disease status (MRDS).
    -Progression-free survival, calculated as the time from first treatment to either the first progression of the disease or the date of death, whichever occurs first.
    -Induction of molecular CR (CRm) (for patients with patients with molecular abnormality detected before starting ASCI treatment). (CRm is defined in Appendix G).
    Induction of cytogenetic CR (CRc) (for patients with aberrant cytogenetics detected before starting ASCI treatment).
    WT1 mRNA transcripts levels in peripheral blood samples.
    Induction of molecular CR (CRm) (for patients with patients with molecular abnormality detected before starting ASCI treatment).
    Induction of cytogenetic CR (CRc) (for patients with aberrant cytogenetics detected before starting ASCI treatment).
    WT1 mRNA transcripts levels in peripheral blood samples.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - first patient : December 2011
    - interim analysis : November 2012
    - last patient : November 2013.
    - last patient follow-up : November 2015
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety of combining ASCI with in vivo Treg depletion and T cell infusions
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Treatment or care after the subject has ended his/her participation in the trial is the expected normal treatment for leukemia.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-30
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