EUCTR2011-004144-22-BE
Active, Not Recruiting
N/A
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)
Institut Jules Bordet - Université Libre de Bruxelles0 sitesSeptember 27, 2011
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Institut Jules Bordet - Université Libre de Bruxelles
- Status
- Active, Not Recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Not specified
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